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					     28/9/00                          C/ 853

 1                      THURSDAY 28 SEPTEMBER 2000
 2                   THE HEARING RESUMED AT 10.00 AM
 4   CHAIR:      When you‟re ready Mrs Sholtens, or is it Mr Murray.
 5   MR MURRAY:           I‟m sorry, it‟s still me. Just some preliminary matters
 6   first.   The Ministry advises that exhibit 48 which was the suppressed
 7   laboratory review information has been the subject of an official information
 8   request which was withheld on the grounds of this suppression order but that
 9   has been overruled by the Ombudsman so that‟s outside this hearing and so
10   be it. But I thought it appropriate to warn that the Ministry has done what it
11   thought it should do.
12   CHAIR:      Well thank you Mr Murray. The inquiry‟s view at the time when
13   it made the suppression order was that the information in its full form was
14   not necessary for the inquiry to be able to answer the terms of reference and
15   as it wasn‟t relevant information for the inquiry‟s purposes and given that it
16   had been received in confidence, the inquiry‟s view was that the
17   confidentiality should be preserved but equally the inquiry is aware that
18   when the Ombudsman comes to rule on matters under the Official
19   Information Act he approaches it from a completely different perspective to
20   what the inquiry does. It‟s not surprising that under the Official Information
21   Act he has decided to have the information released so it is of no concern to
22   the inquiry other than it makes the suppression order redundant and it‟s
23   really just, there‟s usually a general principle that once an order is redundant
24   or once confidential information is out in the public domain, there is no
25   longer a need for the suppression. So it seems it would be sensible to lift the
26   suppression order, do you have any comment to make on that?
27   MR MURRAY:          I think we just won‟t make any comment or submission
28   and that‟s for the inquiry, but if it‟s in the public domain anyway the
29   suppression order becomes irrelevant.
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 1   CHAIR:         Well it becomes irrelevant and it‟s silly having an order which
 2   technically someone can still be in breach of if they happen to be a party to
 3   this inquiry because they‟ll have the document as an exhibit but if they were
 4   to use it in anyway, they could still technically be in breach of an order
 5   when the information is available throughout other sources now.
 6   MR MURRAY:            Yes and the Ministry might be asked to comment on it
 7   and then find that it‟s in a dilemma because it is a party and the suppression
 8   order might bite. I believe because the information actually is so unhelpful
 9   to anyone because it is statistical information that has no real meaning
10   unless you..
11   CHAIR:     Yes it‟s very old and out of date and it‟s been severely criticised
12   in terms of its robustness.
13   MR MURRAY:            Yes and the Ministry is going to make it clear when it
14   releases the information, well don‟t read much into this because no one is.
15   So that was that point. If you want to formally just confirm that that order is
16   lifted.
17   CHAIR:     I‟ll just hear from counsel assisting but that seems to me to be the
18   way to go. Mr Hindle?
19   MR HINDLE:          Yes Ma‟am that‟s obviously right, I just wondered whether
20   it‟s worth making the lifting of the suppression order a contingent on the
21   actual delivery of the information by the Ministry under the Official
22   Information Act. I‟m just conscious that in case there is right of appeal or
23   further consideration until the Committee actually knows that the
24   information has hit the public domain, it may want to just leave the status
25   quo.
26   CHAIR:     Yes that‟s wise. Mr Murray do you know anything about that?
27   MR MURRAY:            I don‟t know the exact date of release, it‟ll probably be
28   this week but it would be appropriate to word the suppression order, the
29   lifting of it, on the basis that once it goes into the public domain that the
30   suppression order no longer applies.
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 1   CHAIR:     Right, well if I tide that so, because it‟s very hard to say when it‟s
 2   in the public domain. If I made it specifically on the day the Ministry
 3   releases the information to the requester, so we will have a specific point in
 4   time. I‟m not sure what the ruling number was.
 5   MR MURRAY:         Six I think.
 6   CHAIR:      We‟ll get it and we‟ll deal with it now. On 3 May 2000 under
 7   Committee ruling No. 6, the Committee ruled that exhibit GRB/MOH/048
 8   which contained laboratory reports showing statistics on laboratory
 9   reporting rate would be produced as an exhibit in its entirety to the
10   Committee but that the Committee would suppress any information which
11   might enable the laboratories to be identified. The Committee did this
12   because the laboratories were not themselves before the inquiry and had no
13   opportunity to make submissions to the Committee. The information had
14   been obtained from the laboratories by the Ministry in circumstances where
15   there was an obligation of confidence on the Ministry to preserve the
16   confidentiality of the information and the Committee had decided that for
17   the purposes of it reporting to the Minister under the terms of reference it
18   was unnecessary for the identities of the laboratories to be made known
19   publicly. The information contained in the statistical reports related to the
20   year June 94, the information was almost six years old and on top of that,
21   the Committee had heard evidence from experts that the value and reliability
22   of the statistical information was doubtful. The Committee has now been
23   told today by counsel for the Ministry that a requestor for the information
24   contained in exhibit GRB/MOH/048 a requestor under the Official
25   Information Act access to the information in its full form which identified
26   the laboratories. The Ministry had withheld the information but on an
27   application to the Ombudsman the Ombudsman has ruled that the
28   information should be made public. It seems to the Committee therefore
29   that there is little point in it maintaining the suppression order that it made
30   on 3 May 2000 because the information will be in public domain. Those
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 1   persons who are parties to the inquiry including the Ministry will be placed
 2   in a difficult position if they wish to comment or in any way refer to use
 3   information which is now in the public domain but which as the result of
 4   being a party in this inquiry, they are still affected by the suppression order.
 5   There is no point in having a suppression order that is of no effect. For
 6   these reasons, the Committee has decided to lift the suppression order.
 7   However the Committee has been told the information has not yet been
 8   released and it is likely to be released next week. The Committee therefore
 9   directs that the information will remain under the suppression order made on
10   3 May 2000 until such time as the Ministry of Health releases the
11   information to the requestor. On that day, the suppression order made on 3
12   May 2000 will expire.
13   MR MURRAY:           The next point is that in our submissions, thanks to the
14   researchers of Mrs Sholtens, we found this article from the Chicago Law
15   Review about hindsight bias and we have copies of that article if I could
16   make it available to the panel and counsel. Is it a situation where we really
17   should have heard some expert evidence from psychologists, psychiatrists
18   etc. in hindsight bias.
19   MR MURRAY:          No definitely not. Lawyers are very well qualified to deal
20   with this concept I believe. And the legal writing seems to indicate that I
21   have some support for that view. Actually although it‟s legal writing it
22   draws on psychological studies so it‟s the psychology brought into the law.
23   CHAIR:     Yes.
24   MR MURRAY:            The next thing before we ended last night, we were
25   talking about this relationship between the Midland Regional Health
26   Authority and Ministry of Health and their respective responsibilities
27   flowing from the funding agreement which quoted the policy. If I can just
28   round that off, I don‟t want to go into too much more than I did last night. It
29   is quite complex but the way I was talking about this last night as that I was
30   referring to the two performance indicators in the funding agreement,
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 1   namely the requirement for the Regional Health Authorities under the
 2   funding agreement to monitor and report on enrolment of women and
 3   colposcopy waiting times. I indicated that conceivably more indicators
 4   could have been added to the list to better safeguard the screening pathway
 5   but the only point I would like to clarify is there is a difference between that
 6   type of performance indicator and the more technical standards that apply to
 7   laboratories reading cytology. In the Ministry‟s 91 and 93 policy, as the
 8   panel knows 4.1.4 of the 93 policy for example, lists criteria for cytology
 9   and the Ministry‟s technique for implementing those criteria was not to use
10   the funding agreements and the formal mechanism through the funding
11   agreements, the Ministry‟s technique for implementing those criteria was to
12   have an expert advisory group called CALC identify the criteria. They were
13   then put in the policy and then the Ministry sends them to TELARC so that
14   the end result is that TELARC applies the criteria, TELARC being the more
15   technical body that is able to credit laboratories against those standards.
16   This is probably where there is need for some clarity because Ms Glackin in
17   her brief of evidence at paragraph 291, you will recall I think, Ms Glackin‟s
18   referring there to the content of the policy in the detail relating to cytology
19   and she is saying that it could be read as intending that the Ministry would
20   in some way be responsible for confirming laboratories were meeting all the
21   criteria required for TELARC registration and this was clearly not possible.
22   All she is really saying is that this policy technical, it‟s cytology criteria, it‟s
23   been identified, it‟s been passed to TELARC, the Ministry can‟t go out and
24   monitor at that level of detail so what the Ministry has to rely upon is that
25   the Regional Health Authorities will pursue reasonable endeavours to
26   achieve TELARC accreditation. So you‟ve got two streams of activity,
27   you‟ve got the funding agreement, reasonable endeavours and on the
28   Regional Health Authorities, achieving TELARC accreditation when that‟s
29   achieved TELARC is applying these criteria that the Ministry has
30   promulgated and I think that‟s where the evidence in our submission we say
     28/9/00                           C/ 858

 1   it all ends up with Dr Lambie referring to the clear obligation in the funding
 2   agreement on the laboratories to use reasonable endeavours to get TELARC
 3   accreditation.
 4   CHAIR:      I think no, it‟s actually the Regional Health Authority has to use
 5   reasonable endeavours to get laboratories to become TELARC accredited.
 6   MR MURRAY:          I didn‟t get that quite right. But in any event, that is the
 7   mechanism and in our evidence, we explain that when we get to Dr
 8   Lambie‟s evidence he quite rightly comes back and says yes but it still
 9   depends on the TELARC accreditation and if that is done that achieves what
10   is required. Of course there‟s two residual issues then if that submission is
11   right, one is how good were the criteria and the second one is, how long did
12   it take for the laboratories to achieve TELARC accreditation.
13   CHAIR:      I think there is a third too and that is why anyone would choose
14   to organise matters in that way because obviously the simple way is for
15   someone to have line authority who does everything. If one tried to run an
16   army in this way you‟d have chaos. What you‟re saying here is that when
17   you look at it and this is what I think came out from Mr Mule‟s evidence
18   too, there was a reliance after 93 on contracts and funding and so in a sense,
19   people I would have thought would look to contracts to set out their
20   obligations. They would receive budgets, they might have felt they were on
21   a tight budget and I would think therefore they would only do what they
22   were obliged to do under their contracts. In that sense to be running the
23   policy and the minimum requirements in 4.1.4 separately to the contracts
24   seems to me to itself create difficulties because you‟ve got so many different
25   people. You‟ve got the Regional Health Authority who under the contracts
26   has to use reasonable endeavours to get the laboratories accredited. You‟ve
27   got the Ministry who was responsible for monitoring and evaluation and it‟s
28   responsible for confirming that the laboratories meet the requirements in
29   4.1.4 but it can‟t actually do that itself it has to fall back on others. The way
30   it does it is it first of all goes to an entirely voluntary Expert Group which
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 1   didn‟t meet that often to set come up with the criteria and then it has to ask
 2   TELARC to take on board the criteria in an environment where the Ministry
 3   itself can‟t say to TELARC you take on this criteria and then laboratories
 4   must be accredited by you because the accreditation process is left over to
 5   the Regional Health Authority. So you‟ve got so many different players and
 6   given that once you look at the way the set up, I think you can say ultimately
 7   well the Ministry of Health is the Government agency responsible for the
 8   programme in a sense the Minister of Health is a person ultimately
 9   responsible for the delivery of health services. Through the Ministry, you
10   would say at some point someone given the delays that occurred should
11   have stood back and said well the current system that we have set up is not
12   working because in 91 we recognised that laboratories should be TELARC
13   accredited. We expected then that it would be done by 93 and 93 we have
14   this new system and as time went by each year 94, 95, concern should have
15   been growing why isn‟t something happening here.
16   MR MURRAY:          Yes well that‟s obviously a legitimate question but the
17   submission I suppose I‟m outlining starts from the premise that the Health &
18   Disability Services Act created these structures so that I‟m saying when one
19   is focusing upon the role of the public servants and the Ministry, have some
20   pity because it was actually the political policy implemented through
21   legislation to create this structure in 93. Then you say alright well how well
22   is that being done? The emphasis of my submissions is first to just try and
23   clarify what actually has been done and the next layer one goes to is well
24   was that a correct or unnecessarily complex way of doing it and with the
25   benefit of hindsight we are putting all this together and saying goodness
26   gracious this is just a screening pathway, why is it being split into two
27   performance indicators going off through the contracts and the technical
28   cytology requirements going out to TELARC. Just to respond now to why
29   is it so complex and why wasn‟t something done, well of course the
30   Ministry itself did recognise that and Ms Glackin in her evidence said that
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 1   there was a project then initiated within the Ministry to make sure that
 2   instead of having this division of responsibility, it was all moved to the
 3   Regional Health Authorities.       The Minister said no, hold it, we‟re
 4   restructuring but eventually the Ministry did in 1998 manage to move it to
 5   the Health Funding Authority where that did at least give the screening
 6   programme a central home and of course now we are restructuring again.
 7   CHAIR:      yes. Well it seems to me a number of issues in what you say.
 8   The first is the contract model could have been used in such a way that the
 9   clauses 4.1.2 to 4.1.4 were brought into a contract. The contract model
10   could have been used so that instead of the Regional Health Authorities to
11   use reasonable endeavours and a benchmark or a performance indicator was
12   written into the contract, Regional Health Authorities are to ensure
13   laboratories reading cytology are TELARC accredited by the year 94/95. If
14   that had been an indicator in the contract then Dr Lambie‟s unit could have
15   come along the next year and look to see what each Regional Health
16   Authority was doing and was it meeting the performance indicators or not.
17   It‟s not the contract model that is at fault in fact utilised effectively, the
18   contract model may have allowed things to move forward in the sense that if
19   you had written into the contract model the requirement that laboratories
20   instead of even going to TELARC, you just wrote into the contract to say
21   the Regional Health Authority was 1) to use TELARC accredited
22   laboratories for cytology purposes 2) the Regional Health Authority was
23   only to contract with laboratories to read cytology for those laboratories that
24   were reading a minimum number. There must have been persons within the
25   Ministry who could have thought of an appropriate minimum number
26   because way back in the days of the Straton Report, there was evidence of
27   the need for minimum numbers. If you go through all the things in 4.1.4 the
28   criteria they could have been identified and written into contracts, but they
29   weren‟t.
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 1   MR MURRAY:          Yes and I don‟t think that I‟m arguing that that technique
 2   was available. My main emphasis is to actually explain what has happened
 3   so that the inquiry can determine whether that was very appropriate or not.
 4   The explanation for what has happened seems to go back to the advisory
 5   committees that the Ministry relied upon and that is probably the heart of
 6   where it diverged out through the path to TELARC.            Because it was
 7   regarded as an area for expert advice, the Ministry relied upon cytology
 8   pathologists in advisory group and they said this is the way you do it. Now
 9   obviously today we‟d say well looking back why did we allow those
10   advisory groups to perhaps have the final say, why didn‟t we stand back and
11   think hang on we‟ve got a contracting structure let‟s be a little bit more
12   rigorous here and go down the contracting route rather than putting it out to
13   TELARC and hoping that those criteria will bite when the laboratories come
14   under TELARC accreditation in the regions. I probably can‟t take it much
15   further than that although Mrs Sholtens can probably explain the advisory
16   group role at the origins of that.
17   CHAIR:        It seems really that although you have focused a lot in 93
18   onwards in the contract model that the seeds for what went wrong were
19   sowed at the beginning. If you look at Dr Boyd‟s evidence in the documents
20   he put out to the then Minister of Health in December 88, his
21   recommendation for a Chief Executive and an internal board within the
22   Ministry which would control the programme fits with most people‟s idea of
23   management and how you would get something done. That was disregarded
24   and instead you seem to have a situation where although the programme was
25   Ministry‟s programme, it tended to rely on other people a lot to have it
26   moved along. A lot of these people were volunteers or receiving a small
27   amount of money too which is surprising to see how one could think as
28   something as complex as a screening programme could actually be got off
29   the ground and implemented with the help, and this is not to knock the
30   advisory groups, they were well meaning, but normally exercises of the
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 1   complexity of the National Cervical Screening Programme would be carried
 2   out by persons on good salaries with good experience and sufficient
 3   authority ultimately that if they couldn‟t persuade the people whom they
 4   need to persuade in order to get the programme implemented, they had some
 5   authority to do something.
 6   MR MURRAY:          Yes and looking back, one can see these principles quite
 7   starkly.   Even looking forward there were individuals identifying these
 8   issues but I think the point that we make in our submission is that the full
 9   complexity of this process was not fully understood. Even though advice
10   was given the implementation of the advice was a whole new ball game. It
11   was easy for experts in particular fields to say well this is how you should
12   do it. To try and implement that advice in a complex health structure that
13   wasn‟t designed for a screening programme like this seemed to be the
14   challenge that took a long time to crack. It was cracked but it just seemed to
15   be excruciating to get everything coming up right on each of the points that
16   were required.
17   CHAIR:       There‟s one other point too which I think is clear from Ms
18   Glackin‟s evidence at paragraph 291. When she says that paragraph 4.1.3
19   could be read as intending the Ministry would be in some way responsible
20   for confirming laboratories were meeting all the criteria, this in itself is quite
21   important because it seems and we‟ve moved back into the 93 structures,
22   where people are working in accordance with contracts it‟s often how they
23   understand a contract and so to set a system up that was based on contract
24   models where obligations were not clearly expressed, where obligations
25   were present or could be perceived to be present because Ms Glackin
26   concedes that paragraph 4.1.3 could be read as the Ministry having
27   responsibility. Now the impact of that would mean that the Regional Health
28   Authority reading it that way, seeing it that way, may well have thought that
29   it‟s the Ministry‟s that‟s going to do these things not us. Who was right and
30   who was wrong doesn‟t matter, what I‟m talking about now is if you‟re
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 1   going to use contract models, the obligations of each party have to be very
 2   clearly expressed because if they‟re not clearly expressed, you get the
 3   danger that both parties have a different interpretation and so each one does
 4   something different and the end result is something falls through the gaps.
 5   MR MURRAY:          Yes and I think that the Ministry is just acknowledging
 6   that concept there that Ms Glackin‟s frankly acknowledging that that was a
 7   risk.
 8   CHAIR:      The Ministry‟s evidence has been very well prepared and a full
 9   credit to you and Mrs Sholtens in terms in which you‟ve discharged your
10   ethical obligation ensuring that the Committee is fully informed of what
11   occurred and we do most appreciate that.
12   MR MURRAY:              Yes as you know we haven‟t taken a very defensive
13   approach to this inquiry and all credit to Mrs Sholtens I might say who
14   prepared the Ministry‟s evidence.       It has actually been interesting that
15   although the inquiry has ranged far and wide that a lot of the evidence has
16   come back to Boyd and Glackin. So we seem to have captured the heart of
17   this in the evidence.
18   CHAIR:       Yes if the Boyd and Glackin evidence hadn‟t been so well
19   prepared, the Committee and other parties may well have been struggling
20   and it is to your credit. We are all here I mean this is not a court case, we‟re
21   not here to apportion blame, we‟re here to find out what happened. The
22   preparation of the Ministry‟s evidence has enabled us to do that.
23   MR MURRAY:              Well our instructions were to take that open approach
24   regardless of the consequences. The only point I would add and ask the
25   inquiry to take account of when writing the report is that Dr Boyd of course
26   only had first hand knowledge at the very early stages and Ms Glackin had
27   some managerial responsibility at some of the stages but neither of those
28   two witnesses had direct knowledge of everything that the huge area that
29   they covered in their briefs. I know we as counsel were concerned that
30   because they were first up, they were asked to go well beyond their
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 1   knowledge and did so willingly to be helpful but we think it probably took
 2   some hits that they shouldn‟t have taken because they didn‟t have direct
 3   knowledge. If when the inquiry panel is reviewing their evidence, our
 4   submission is that that should be taken account of and if they are
 5   contradicted or they‟ve appeared to be evasive, it‟s not because they were
 6   evasive, it was because they actually didn‟t know but were endeavouring to
 7   piece together the Ministry‟s documents and offer a view that might help the
 8   inquiry forward. I just mention that because we as counsel did have a
 9   concern at that stage of the inquiry.
10   CHAIR:        Well if there are any passages in the evidence that are of
11   particular concern, point them out so we know which ones they are.
12   MR MURRAY:           I‟ve almost finished, there was only just a couple of
13   points. Turning to the Royal College of Pathologists, the College seem to
14   have some concern about its relationship with Government, it seemed to
15   think that it wasn‟t consulted enough and I just want to refer to a passage.
16   The Royal College‟s submission at page 43 deals with my cross examination
17   of Dr Tie, it‟s page 43 at paragraph 8.11.
18   CHAIR:     My paragraph 8.11 is on page 46.
19   MR MURRAY:         Yes I wonder if it‟s the difference between electronic and
20   hard copy.     It‟s definitely the submissions of counsel, it‟s definitely
21   paragraph 8.11.
22   CHAIR:     That‟s fine, I can follow it from paragraphs.
23   MR MURRAY:          It starts off, it is further submitted there appears to be a
24   strong likelihood that there will be better liaison between the Ministry and
25   the College in the future. Then there is a quote from my cross examination
26   of Dr Tie and I put to him “so you can see that in fact the list is quite
27   extensive” but this is a bit of a selective quote because what I have put to Dr
28   Tie was the Health Funding Authority‟s engagement of the Royal College
29   on a number of important matters, the panel will recall that the Royal
30   College was invited to participate in development of the Sylvia SACS
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 1   general standards along with TELARC and they were actively involved in
 2   that exercise.     When the Gisborne situation broke, the Health Funding
 3   Authority consulted with the College and did not accept the advice or the
 4   position of the College about rereading the smears and was quite entitled in
 5   my submission to go away and get other advice and take the course that we
 6   know was taken. We also know that when the National Laboratory Review
 7   was done, the evidence of Mr Du Rose makes it clear that the Royal College
 8   was brought into that exercise and the College had a cytology focus group
 9   and that was group was engaged to work with the Health Funding Authority
10   on that National Review.        So that when one goes to the front of the
11   submission at page 2, at the end of the introduction the College submits that
12   the hearing is shown the key determinant of observants of standards and the
13   operation of the scheme lies with Government. My submission the inquiry
14   panel should just be alert to the fact that it‟s not really sufficient for an
15   organisation like the Royal College to say well if things go right because of
16   our advice well that‟s good but if you don‟t get our advice and it goes
17   wrong, well the responsibility lies with Government. I‟m not really trying
18   to make a big issue of this but I just do think that we need to fairly point out
19   that Government certainly has a role but the Royal College has been
20   engaged in the development of standards and it‟s been a two way process.
21   CHAIR:         Yes but as a matter of principle, the last paragraph on page 2,
22   well that‟s the way it is in my copy which is the paragraph where the
23   sentence begins “it is submitted that the hearing has shown the key
24   determinant of observants of standards and the operation of the scheme lies
25   with Government, it is the funder, the legislature, the legislator, the health
26   care provider and therefore the body who must lead”. In principle, do you
27   accept that?
28   MR MURRAY:             No in my submission that is debatable. In an area as
29   specialised as cyto-pathology in my submission there is scope for the Royal
30   College to take a lead. It is not correct to say that the Government is the
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 1   health care provider, the whole language of the health sector at the moment
 2   is that the pathologists are the providers.
 3   CHAIR:     Well I think to the public of New Zealand the Government would
 4   be seen overall as the health care provider because most people still see us
 5   as having a public health system to some degree. It could also be said I
 6   think from the public perspective that in terms of cytopathology, when
 7   you‟re talking about the Royal College of Pathologists and ACL laboratories
 8   that those persons may be seen as having a vested interest because of course
 9   it‟s the pathologists who some of them derive their income from the
10   laboratories in the Government funding. Without wanting to be insulting to
11   pathologists at all and to say well all they‟re really interested in is making
12   money because I‟m not saying that all but I‟m sure that the public in New
13   Zealand still thinks that ultimately it‟s the Government that has the
14   responsibility to ensure that there is good quality health care and that it does
15   that by ensuring that the appropriate standards are in place.
16   MR MURRAY:          I don‟t think what you‟re putting is really what I would
17   be arguing with. All I‟m doing is just addressing this issue because I do
18   think there‟s a balance here and that when we talk about pathology and
19   pathologists that appeared before this inquiry in different guises, when they
20   come as an ACL participant, it‟s their commercial, not just commercial but
21   their business interests that are being represented. With the College, it‟s
22   their professional interests. When it‟s the individual pathologists they come
23   as individual doctors, providers of health care. The only point of addressing
24   is I just wouldn‟t like the balance to be shifted all on the Government all the
25   time when clearly the evidence shows that the Health Funding Authority has
26   gone out to engage that expertise and has relied upon it and ultimately I
27   accept its decision making for Government for what it does and that is
28   exactly what the Health Funding Authority responsibly did when, I know
29   there is a distinction between your assessment of the Ministry‟s position and
30   the Health Funding Authority and I‟m conscious of that, but with the Health
     28/9/00                            C/ 867

 1   Funding Authority when the Gisborne situation broke, the Health Funding
 2   Authority was very reluctant to accept the assurances of the College that
 3   look you don‟t need to worry there‟s a false negative rate. In my submission
 4   that evidence shows that the Health Funding Authority was alive to the
 5   position of the College whether it was self interest or just not willingness to
 6   look at the reality of it I‟m not saying.
 7   CHAIR:     Well that‟s a good example I think that I was talking before about
 8   the public expectation.       I think their expectation would be that a
 9   Government body be it Health Funding Authority, Ministry of Health
10   whoever is responsible would take that line rather than just listening to the
11   College but stand back and say well what is the best thing to do here and
12   take into account broader issues as well. So in a sense that is a good
13   example of good governing because there the Health Funding Authority did
14   step in and it was presented with a difficult situation and it moved very
15   quickly. In some ways it shows the benefits when you have a body does act
16   with authority, does accept leadership and moves in and takes action and
17   they also seem to get some good legal advice in terms of how could go and
18   look at slides a good five or six years old, on the basis it was looking at the
19   treatment provided. I forget the actual phrase that was used.
20   MR MURRAY:          I haven‟t actually been back over that but I think it was a
21   combination of focusing on the care of women and also women were given
22   the chance to opt out of the slide reread so it was a combination of the
23   concern and treatment of women but recognising that the reread was
24   something else. I think individual letters were sent out and Tracey Mellor‟s
25   evidence was that some small number did actually ask not to have their
26   slides included within the reread. So it was a combination of…
27   CHAIR:     Did they go to every woman and get the consent of every woman
28   to look at her slides?
29   MR MURRAY:          I can‟t recall exactly.
30   CHAIR:     Because I haven‟t seen that.
     28/9/00                          C/ 868

 1   MR MURRAY:          There were two things happening. There was a public
 2   relations campaign of course and then there was also correspondence, the
 3   Health Funding Authority did a huge mailout of information about what was
 4   going on. I can‟t be clear on the evidence, counsel assisting may be able to
 5   recall whether one of the letters in Tracey Mellor‟s evidence made it clear
 6   that they were doing a reread and women could opt off, in which case they
 7   should write to the Health Funding Authority.
 8   CHAIR:      But you see that is different in the sense that if you take the
 9   difficulties the National Evaluation exercise has gone through, the Doctors
10   Cox and Richardson have been required to obtain consent. What it seemed
11   the Health Funding Authority did is said we‟re going to do this, let everyone
12   know and then said if you don‟t want this to happen to you, let us know. So
13   they were more or less saying your consent will be implied by your failure
14   to act and let us know you don‟t want to be part of it. Which is a more
15   practical way of getting consent from large numbers of people but I don‟t
16   think it would meet the tests the Doctors Cox and Richardson were required
17   to meet through the Ethics Committee.
18   MR MURRAY:          No. In my submission the solution to this is a balance,
19   I‟m not talking about a short term solution but I do think that at the front of
20   the programme, the concepts of evaluation have to be clearly articulated so
21   women know that there is a personal benefit for being on the programme
22   and there is a benefit to the population as well. The advantage to women in
23   general is that the programme will work efficiently and so the Ministry is
24   looking at legislation that amends Section 74 so that ideally 74A instead of
25   just being a technical little section, perhaps more reflects where we‟re
26   getting to, the need to have women buy in and give their consent and the
27   legislation therefore confirms that concept so that these evaluations can be
28   done. Having said that, as I understand the current climate in New Zealand
29   and from the experts we‟ve heard is that even with that they would go and
30   get ethical approval because of their necessity to deal with the medical
     28/9/00                           C/ 869

 1   practitioners in the community and their need to feel safe and confident in
 2   that relationship. That‟s the policy debate that may have to occur.
 3   CHAIR:       Well it seems if you look at the provision, I think it‟s 64k of the
 4   Hospitals Act, that used to be enforced that allowed the Minister by gazette
 5   notice to have access to hospital records, there needs to be some residual
 6   power like that because we‟d have to say well how else are you going to get
 7   access to information if you really need it in an emergency in a case of
 8   necessity.
 9   MR MURRAY:            Yes it may well be that that‟s the residual power that
10   needs to be clear in legislation that despite lack of individual consent,
11   despite lack of ethical approval and if women cannot be contacted for any
12   reason, that it shouldn‟t hold up the achievement of the outcome that‟s
13   required. It‟s just getting that mix right and I‟ve submitted before that 74A
14   might have been a reflection of 93 thinking and the experience in trying to
15   evaluate the programme from 96 onwards, the delay in identifying the issues
16   but now the identification of the problem…
17   CHAIR:       What do you say to Ms Coney‟s submission though which was
18   that well it was always expected by women that the programme would be
19   evaluated and monitored and that at the time she was going out selling 74a
20   to women‟s groups.       The expectation was that the Register would be
21   available for monitoring evaluation purposes and she never expected the
22   section to have the impact that it has done in terms of making it difficult for
23   researchers to get access to information, not researchers, auditors, I‟ll call
24   them that.
25   MR MURRAY:            I think that Sandra Coney‟s evidence and submissions
26   were very interesting because take that as one side of the equation but she
27   was also very clear that you shouldn‟t override consent. Her submission, I
28   thought very fairly, identified the problem we‟re grappling with here.
29   CHAIR:       Well they identify a problem which really can‟t be resolved if
30   people want to have their cake and eat it too. If they want to have a full
     28/9/00                              C/ 870

 1   evaluation exercise go ahead but have the consent of all women, it‟s difficult
 2   to see how that can really happen in the real world. It‟s all very well to talk
 3   about educating women and getting them alongside, I mean that‟s falling
 4   back into that consensus persuasive model, it‟ll work to a degree but you
 5   have to realise that there are times when it won‟t work and when it doesn‟t
 6   work, force of circumstance will mean you don‟t get an evaluation. Your
 7   choice then is either you have a thorough evaluation or you don‟t have a
 8   thorough evaluation.
 9   MR MURRAY:          I think the legislation perhaps just doesn‟t go quite as far
10   as enough to expose the importance and the methodology for achieving that
11   evaluation and that‟s the policy work that‟s being done now and I think a
12   paper‟s going to Cabinet on that.
13   CHAIR:      Well the other problem though is that at the moment it seems it‟s
14   the Ministry of Health who write the guidelines for Ethics Committees and
15   obviously they would do that in consultation with the Ethics Committees but
16   there is no reason that I could see why the guidelines couldn‟t deal with the
17   way the Ministry actually operates. So that whereas the guidelines at the
18   moment have clearly provided for internal audits, given that the Ministry‟s
19   approach and the approach of a number of people is that an external audit
20   may be more credible, the ethics guidelines should allow external audits to
21   be treated in the same way as internal audits. Because provided the external
22   auditors are contracted on a basis whereby they‟re obliged to keep the
23   personal information they see confidential in the sense they get full access to
24   it but when their report comes out, you‟re not identifying women, it‟s hard
25   to see that that is objectionable.
26   MR MURRAY:             That‟s right and if the guidelines of course can be
27   changed I would have thought much more expeditiously than making new
28   statute law or regulations so that‟s something that may find its way into the
29   inquiry‟s report and produce an immediate outcome if not before. There‟s
30   just one point about the 74a which I don‟t think has come out and that is I
     28/9/00                          C/ 871

 1   recall Mr Rennie conducted a satirical review of some basic statutory
 2   interpretation around 74a and he was a bit critical of the Crown Law opinion
 3   because the focus with all the regulation making power referred to studies,
 4   persons studying cancer. I think there is a more fundamental point and that
 5   is we have to recognise the distinction between private researchers who are
 6   advancing the cause of cancer research and public bodies like the Ministry
 7   who have responsibility for a programme and need to be able to either
 8   employ inhouse the expertise to carry out the audits and evaluations or
 9   contracted out.    But whether they have internal expertise or external
10   expertise, there shouldn‟t be legal barriers for the public body achieving its
11   own objectives.
12   CHAIR:      That's right, I think on one reading of 74A the current approach
13   the Ministry‟s taking that its staff will look at the Register and do the
14   matching exercise could well be in breach of this section because the section
15   says no person may use this information. And it could be said well yes the
16   Ministry staff can have access to the Register in order to maintain the
17   Register to put data into it to keep it etc., but they too are bound by this
18   prohibition no person may use information that identifies a woman for these
19   purposes.
20   MR MURRAY:          That‟s another point. I don‟t think that‟s causing much
21   trouble in the Ministry as I understand it because the fact that no person,
22   there is no person other than the Director General, the Director General
23   being the Head of a Ministry there‟s quite a number of staff that need to
24   manage the Register, there‟s computer people. Because now that the Health
25   Funding Authority screening team is coming back into the Ministry that
26   separateness has come together and you‟ve got the Director General in
27   charge of two registers and the Ministry doesn‟t seem to be too concerned
28   about the use of the information internally.
29   CHAIR:      That‟s the point. It‟s not for me, well the Committee should
30   comment if it thinks the Ministry is acting unlawfully on this point. You
     28/9/00                          C/ 872

 1   look at sub-section 5, you take this creative approach, you don‟t read that as
 2   including the Director General, I don‟t see why not. You could say no
 3   person including the Director General may disclose information on the
 4   Register that identifies a woman unless there is consent. If you disclose
 5   information from the Register as a result of an information matching
 6   exercise and ultimately the recipient is able to identify the woman, there is
 7   the possibility that that is a breach of 74A. Because it leads to the woman
 8   being identified and you‟re disclosing it for those purposes.
 9   MR MURRAY:           I think at that point I rely on Ms Coney‟s evidence in
10   submissions.
11   CHAIR:         You‟re chopping and changing there. I just point this out
12   because…
13   MR MURRAY:          That certainly could go on a list of issues that could be
14   clarified if 74 is being…
15   CHAIR:     Well if it‟s going to be clarified I think it needs to make it clear
16   that this no person prohibition applies to persons 1) outside the Ministry but
17   2) you may well want it to apply to persons who are outside the Ministry
18   when it comes to external auditors.
19   MR MURRAY:          Yes, well we‟re looking at this very constructively. We
20   haven‟t put that issue on our list because we hadn‟t seen it as a serious
21   concern, we did think that the Director General had the responsibility for
22   both registers, had certain obligations in that regard and although the
23   information of course is made available to many people in the Ministry, they
24   didn‟t see it as an impediment to themselves looking at the information for
25   evaluation purposes.
26   CHAIR:      I don‟t see there‟s anything wrong maybe if they look at it too.
27   There is that possibility, maybe that‟s so. What I‟m concerned about is if
28   ultimately the results they do get passed down the line to an epidemiologist
29   when it comes to looking clinical files, if you look at it as a various staged
30   process at some point for the epidemiologist to make sense of this
     28/9/00                           C/ 873

 1   information, he or she is going to have to know the identity of the woman.
 2   Because he or she may want to look at the woman‟s slides, the woman‟s
 3   medical files etc. And at that point she is going to be identified.
 4   MR MURRAY:         Those are my submissions, I‟m keen to hand over to Mrs
 5   Sholtens.
 6   CHAIR:       One other thing I would like to ask you though because it‟s
 7   become clear to me that the Cox Richardson Study on the cancer audit hit
 8   difficulties with the Cancer Registry, wasn‟t a 74A problem there and with
 9   the Ethics Committees. It seemed to me that at the moment given the way
10   the standards for Ethics Committees are set out, the problem for persons
11   carrying out audits of health services, be it cervical screening in fact be it
12   any health service, is going to be a very live issue. It‟s not a 74A problem,
13   it‟s a problem relating to the way the standards are set out for Ethics
14   Committees because anyone who wants to go and do an audit of health
15   services has to look at patient information of some sort be it on a health
16   register, a database, hospital records, GP records whatever. It‟s going to
17   presumably have to get Ethics Committee approval and that could founder
18   on the need for consent.
19   MR MURRAY:         I believe that those issues have actually been addressed or
20   are being addressed now. The health research counsel has become involved
21   and I think it‟s going to be resolved in two ways. One is of course the
22   Ministry will apply the Privacy Act and or Official Information Act
23   depending on the nature of the exercise.          Two, the Cancer Registry
24   information and that means the information should be released for the
25   purpose for which it was collected. That problem I think with just some
26   brief legal advice should be resolved. I think then if you accept that external
27   researchers are always going to want Ethics Committee approval, it is then
28   important that the standards recognise responsibility of a public body to
29   evaluate its programme, gauge the best experts it can in a country and make
     28/9/00                           C/ 874

 1   sure that the guidelines or the standards take account of that discreet
 2   situation which is quite different from general research.
 3   CHAIR:      Yes, it‟s used purely for the purpose to see whether or not the
 4   health service is working properly. It‟s very hard to say well it‟s better to
 5   protect people‟s privacy and we‟ll just hope for the best in terms of how
 6   well the health service is going because that‟s the alternative.
 7   MR MURRAY:          Yes but if that machinery is all aligned, one would have
 8   thought that it‟s the best of both worlds because the external researchers do
 9   have the comfort of an Ethics Committee approval and the clinical providers
10   they inter-relate with can have the confidence that those mechanisms have
11   been properly checked rather than just having to respond to requests from all
12   sorts of people, researchers, who may or may not be representing people, a
13   public body conducting an official evaluation. Personally I don‟t see that
14   the problems are unsolvable and those ones seem able to be resolved
15   without legislation and it‟s only the residual issue, I think there‟s just a
16   narrow area where Section 74A and obviously there needs to be a bit of
17   policy work done on whether the balance is wrong.             The privacy and
18   personal interests of being given preference.
19   CHAIR:     It strikes me as unusual that if I have invasive cervical cancer I‟m
20   on the Cancer Register and someone who meets the tests under Section 9
21   can get access to my information. If I have a high grade abnormality on the
22   Screening Register you‟ve got 74A or a low grade abnormality. People with
23   cancer, their information is there on the Cancer Register I mean certainly it‟s
24   not going to be handed out willy nilly but the test for whether it is released
25   or not is Section 9 of the Official Information Act and you look at balancing
26   personal privacy against public interest. It‟s interesting that lower levels in
27   a sense of this disease in a sense that when it still at the abnormality stage on
28   the Screening Register there‟s a complete block on getting information.
29   MR MURRAY:           Yes it‟s interesting that that issue was addressed in the
30   Crown Law Office opinion.
     28/9/00                               C/ 875

 1   CHAIR:     Was it, I didn‟t see it.
 2   MR MURRAY:          It does seem as if because the taking of a cervical smear
 3   is such a personal matter and could at least imply or indicate something
 4   about a woman‟s sexual history or background. That the whole focus out of
 5   Cartwright has been well that type of information should be securely kept so
 6   that women have the confidence that their smear history is kept in a bank if
 7   you like and it‟s not subject to release except on various grounds. Whereas
 8   once a woman has got cancer, that is a different situation…
 9   CHAIR:     Well the same connotations apply though if you are going to say
10   well this abnormality can come from certain behaviours, the fact that it has
11   progressed to cervical cancer the same connotations can be attached.
12   MR MURRAY:           I think that the Crown Law Office opinion pointed out
13   though that there had been a legislative intention to create an opt off
14   systemic with 74A whereas the Cancer Registry women didn‟t have that
15   choice. The legislative deal with the Cancer Registry is that the providers if
16   they diagnose cancer much register it.         I think the Crown Law Office
17   opinion identified those distinctions.
18   CHAIR:         Yes there‟s actually some good authority in the law of
19   confidentiality which is the reverse of the Crown Law Office opinion which
20   is that information is obtained under compulsion, there is less reason to use
21   it for other purposes. So in other words, if you have to provide your
22   information to the Cancer Register you shouldn‟t have to run the risk of it
23   being disclosed for other reasons.         Whereas if you choose to produce
24   information voluntarily to an agency, then you don‟t have to do it but you do
25   it therefore it can be used for other purposes. There‟s actually an English
26   Court of Appeal case Marcel v. the Commissioner of Police which is in the
27   Appeal Case as anyway you can find it, but there‟s good debate of the issues
28   there. It‟s about other types of information but it looks at this whole issue
29   between the use for other purposes of information that‟s been obtained by
30   compulsion and information that hasn‟t. I know Mrs Sholtens was involved
     28/9/00                          C/ 876

 1   in the Fyser case where the Minister was using information there that had
 2   been presented by one company to get approval to see whether or not he
 3   would approve the generic company‟s drug as well and of course the
 4   company who first put up their information said well hold on we did this to
 5   get our licensing approval, the last thing we want is our information helping
 6   our competitor but that argument wasn‟t accepted.
 7   MR MURRAY:        I remember that litigation.
 8   CHAIR:     I just raise that because the Crown Law Office statement has no
 9   authority to back it up in terms of they don‟t refer to any authority, there‟s
10   no principle, it‟s just the statement is made in the year which is obviously
11   what the writer might think. The fact that there are other thoughts about the
12   issue and these thoughts have found their way into case law and there‟s
13   complete silence on that.
14   MR MURRAY:          I‟ll report back to base on that each year. If the panel
15   pleases, those are my submissions and I‟ll hand over to Mrs Sholtens.
16   PROFESSOR DUGGAN:             Mr Murray, I would like to go back to a topic
17   that I didn‟t completely finish with you yesterday which is your concept of
18   the programme having a past, a present and a future and my concept of the
19   disease being a disease with a 15-20 year history that is a dynamic process it
20   waxes and wanes and it may progress.         How do you marry those two
21   concepts or your concept of the programme having these time periods and
22   my concept of the disease being something unregulated really, how do you
23   fit one into the other. I‟m coming to my question. From 1990 to 96 or from
24   1990 to the present day, many women in New Zealand have been enrolled in
25   a programme something close to 90% of women are enrolled and there is an
26   obligation to these women in terms of delivering a service. It‟s difficult to
27   take the view that or it may be difficult to take the view that what is in the
28   past is in the past and today we deal with a programme that‟s good and we
29   move on. Because you have ten years of women on the programme whose
30   disease may have gone undetected, worst case scenario may have gone
     28/9/00                          C/ 877

 1   undetected. I wonder what your opinion is about that completely because
 2   yesterday you mentioned that you would just draw a line in the sand and
 3   move on, but in terms of a disease that is fluctuating and unregulated, you
 4   have all of those women out there who are wondering about the disease and
 5   in the period 1990 to 2000 a lot of women reached the age of 68 and they‟re
 6   off the programme, they‟re out there, they have no opportunity today to be
 7   in the programme or no opportunity in the future to be in the programme.
 8   I‟ve asked for your opinion but I‟m going to pose a hypothesis or a question
 9   to you as well which is should the programme start all over again when all
10   the bricks are in place because the bricks are not in place yet. When all of
11   those are in place should the programme start all over? That is properly
12   enrol women, following the rules, two smears, one year apart. Only when
13   those two smears are normal and satisfactory and have been interpreted in
14   accredited laboratories and everybody is satisfied that every single thing that
15   should be in place is in place, those women move on to a three year
16   screening frequency.
17   MR MURRAY:         I think you could probably spend another long time doing
18   analysis on those concepts, I‟m just trying to think of a way to cut through
19   it. It seems to me we have a ten year timeframe where we know there are
20   systemic problems with the screening programme and you‟re rightly saying,
21   well how can we responsibly move on unless we‟ve identified women who
22   may be at risk during that time period because they‟ve been affected by
23   failures at one or more points in the pathway. My submission I think is that
24   we have identified numerous systemic problems arising out of one case
25   study which is Gisborne. But the systemic problems have not been the same
26   throughout that ten year period. There have been more serious systemic
27   problems right at the start of the programme that have been increasingly
28   resolved and so I suppose my submission is that it seems unlikely there is
29   obviously still a risk and I believe the Health Funding Authority accepts
30   there is still some risk that there has been underreporting during that ten year
     28/9/00                           C/ 878

 1   period that hasn‟t been detected.      Given that the programme has been
 2   operating, given that laboratory standards have been improving either
 3   voluntarily or because they were required to improve and given that it‟s a
 4   cyclical smear process, you‟ve got a number of factors that are going to
 5   hopefully pick up most of the women who have abnormalities at any stage
 6   during that ten year period. There‟s a huge number of variables in there so
 7   my submissions will have to be taken as a concept answer rather than a
 8   detail answer. But if that‟s right, if the submission is broadly correct, I think
 9   you then get to where the Health Funding Authority arrived at after doing
10   the Du Rose Study. They found variable laboratory practice but no on
11   practicing like Dr Bottrill and so if they had found other Dr Bottrills out
12   there, sole practitioner, no cyto-screener, no internal or external quality
13   control there would be a strong case for the Health Funding Authority
14   saying we can‟t move on, we‟ve got to go back, we‟ve got to look at each of
15   those laboratories, identify the women concerned and take proactive steps to
16   make sure that they are treated if necessary. But the exercise that was done
17   was to assess that risk and it arrived at the conclusion that there was no
18   serious problem of the Gisborne situation that there were examples of
19   coding errors and variable practice in underreporting but that all laboratories
20   had achieved accreditation and cyto-pathology as at 1996 whether
21   voluntarily or mandatory Mr Du Rose didn‟t deal with that. So that there
22   was a justifiable basis for saying that the time has come to implement the
23   Peters standards and move on so that to the extent that women are still in the
24   system they can expect a high quality service to pick them up from this
25   point on if they have abnormalities. Now I don‟t know whether that makes
26   sense but as I read the Health Funding Authority‟s view on the National
27   Laboratory Review that‟s where we‟ve got to. And that does not mean to
28   say we are all confident for the future, this won‟t happen again. What it
29   does mean is that we‟ve identified some serious systemic issues historically
30   that have been resolved, we‟ve identified another group of systemic issues
     28/9/00                           C/ 879

 1   that have not actually been resolved, there‟s data problems, there‟s register
 2   quality, there‟s all sorts of systemic issues like that.       Just to pick one
 3   example was the Dr Peters work on the Register and you will recall you‟ve
 4   focused on that a little bit. So clearly there‟s some issues about getting that
 5   Register working at an even better standard where the regions are using a
 6   standard manual and so you don‟t have diverse practices developing. So all
 7   I‟m saying is that the historical systemic problems even on the evidence
 8   we‟ve heard have been resolved, the next group of systemic issues have
 9   been identified so let‟s make sure they don‟t continue from this point on.
10   That‟s where the inquiry‟s report is the cut off point if you like, the value of
11   the inquiry‟s report is to say there are still residual systemic issues that have
12   come out of Gisborne, these are what they are, we are told under terms of
13   reference 4 that changes have been identified to be made under 5, other
14   changes have agreed to be made and then you say well what‟s left, there
15   may even be things left and they have to be implemented. For example, the
16   Peters standards, there may be something that the inquiry panel has
17   identified there. One example I think the .5% for high grade abnormalities
18   and I think one of the submissions, it might have been Mr Corkill‟s was that
19   on the basis of the evidence there should be a review of whether a .5%
20   standard for monitoring as a performance indicator is appropriate or not.
21   Obviously there is a case for it but there‟s a case that it‟s not appropriate.
22   CHAIR:       I think Dr Peters said they were going to increase it to .6%
23   because Dr Cox thought it was too low as well.
24   MR MURRAY:            Yes that‟s right, there was some evidence about that.
25   Anyway I just used that as an example that we seem to be doing the right
26   things now with those standards, there may be additional points but
27   therefore there is a case for drawing a line in the sand and moving on and it
28   may actually be all we can do because we can‟t go back and historically
29   review millions and millions of smears, it just may not be a viable way of
30   doing a retrospective risk assessment.
     28/9/00                           C/ 880

 1   CHAIR:      But if you had every woman come in again because it may be
 2   that there are women out there whose smears have been under reported and
 3   the disease could be growing and one way of picking it up would be to have
 4   them to come back and reassess them and rescreen them.
 5   MR MURRAY:         I think to an extent the publicity about cervical cancer and
 6   what‟s happened in Gisborne must of itself put women on alert that there
 7   may be a need to go and have a review themselves. Really the focus then is
 8   well if they do that, do we have adequate laboratory standards in New
 9   Zealand to make sure that the report is likely to be accurate.
10   CHAIR:     That is really the crux of the whole problem because it‟s troubled
11   me that you seized on the Du Rose study and said well look there‟s no one
12   else practicing like Dr Bottrill as if that is the litmus test for deciding the
13   problem. Whereas what we do know now is that there was no compulsory
14   accreditation, some laboratories were not accredited, there being no
15   benchmark standards as such in New Zealand for laboratory reporting,
16   there‟s been no evaluation of laboratory reporting to see whether it‟s
17   accurate or not.    Therefore although certainly there are no laboratories
18   around like Dr Bottrill‟s, we accept what you say, how do we know that the
19   laboratories that are around are getting it right. I know because I raised this
20   with Professor Skegg when you look at the Du Rose study. They looked at
21   the information, worked out the average reporting was .8% (point eight) for
22   high grade picked the .5% (point five)…
23   PROFESSOR DUGGAN:            No it was the other way round.
24   MR MURRAY:         .8 (point eight) for all abnormalities.
25   CHAIR:      For all abnormalities? Right. Well my understanding though
26   there is a graph that shows when they were trying to look at what
27   laboratories did they look at, they picked those that were at Dr Bottrill‟s
28   level which was his reporting on the statistics was .5 (point five) and that‟s
29   why they chose .5 (point five).
     28/9/00                            C/ 881

 1   MR MURRAY:          I can‟t recall the detail of that evidence. I don‟t think it
 2   was just the one indicator.
 3   PROFESSOR DUGGAN:               No I think the questioning was why was .5
 4   (point five) chosen and Mr Du Rose finally conceded it was chosen because
 5   it‟s an international benchmark.
 6   MR MURRAY:          He referred to Australia, he acknowledged that wasn‟t the
 7   case for applying it in New Zealand of itself.
 8   PROFESSOR DUGGAN:             He finally did.
 9   MR MURRAY:          Well maybe he shouldn‟t have made that concession but
10   as I understood his evidence it was a notional benchmark, they just wanted
11   something around which they could as a group of pathologists make some
12   decisions.
13   CHAIR:       That's right. Well I understood there was this whole series of
14   laboratories and they picked those that were 5 or under and they had this
15   sort of average of 8 and the concern I had was that it was all based on the
16   information the Ministry has which we know is not robust information. And
17   to use a .5 (point five) benchmark from Australia which is a lower rate of
18   cancer it might not be a good benchmark to use. To say that the average
19   reporting rate of laboratories in New Zealand was 8 may not be good
20   because we don‟t know how accurate they are. In other words without rock
21   solid robust data to begin with, you can create a false impression. It‟s like
22   those statistics that were given to Dr Bottrill which showed exhibit 48 of
23   Glackin. On the face of it, it looked good.
24   MR MURRAY:          As I recall Mr Du Rose‟s evidence was to the effect that
25   they recognised the data from the Register in the early years was not very
26   robust but it became increasingly more reliable.
27   CHAIR:       Well how do you know it‟s reliable when there‟s never been any
28   thorough monitoring and evaluation.         If there‟s never been a thorough
29   evaluation of laboratory smear reading, how do you know that the reports
     28/9/00                            C/ 882

 1   that they provide and the statistical information you extract from those
 2   reports is robust?
 3   MR MURRAY:           Well that part of the evaluation has been done actually. I
 4   mean we haven‟t got it in the evidence but he‟s got to write it up, I think
 5   he‟s done the study and he‟s got to write up the data integrity on the
 6   National Cervical Screening Register .
 7   CHAIR:     Well when he‟s saying data integrity does that include, because I
 8   thought it was actually his cancer audit that was going to show if there had
 9   been underreporting. I didn‟t think the data integrity study would actually
10   show you that there had been underreporting because what I‟m saying is that
11   it‟s all very well for a laboratory to send in reports and they might be picked
12   up and accurately recorded and all the rest of it, but if there is a component
13   of underreporting in those reports, it‟s going to skew your data.
14   PROFESSOR DUGGAN:               As I read Dr Cox‟s brief methodology on the
15   data integrity he was to determine how complete is the data on the Register.
16   Of course we learned from Mr Du Rose‟s study that the coding is done in
17   the laboratory and then the laboratory forwards, the Register doesn‟t really
18   check that coding and if it had been checking the coding, it would have
19   identified many years earlier that they had coding problems. So the point is
20   I do not believe that Dr Cox‟s study will address this particular issue.
21   MR MURRAY:           Well we‟re all in trouble then.
22   PROFESSOR DUGGAN:              Unless he‟s changed the methodology.
23   MR MURRAY:           But I do think we‟re talking about two different things at
24   the same time. One is identifying the risk to individual women historically
25   and the other one is working out what might have gone wrong with the
26   programme historically and I don‟t think they‟re directly the same thing.
27   Therefore even if the evaluation is done and even if the methodology is
28   appropriate, if it shows under reporting it wouldn‟t necessarily show where
29   you go and find the women who are at risk as I understand.
     28/9/00                         C/ 883

 1   CHAIR:      No that‟s why you need the clinical audit and that‟s why we
 2   wanted the four region study to determine. One was the systemic problem, I
 3   know you‟ve conceded that but what was the nature of the systemic
 4   problems, was there underreporting in other areas and it‟s a clinical audit
 5   which will show that up. Because you see if you look at the statistical
 6   information you‟re getting, imagine for the moment that 50% of the
 7   laboratories that are sending you in information are Dr Bottrill. They‟re Dr
 8   Bottrill types, that‟s what the information‟s like. It‟s going to skew your
 9   data completely because you‟d think everything is alright and until you go
10   back and you actually check and you see whether or not the smear reading is
11   accurate, you have a false picture. Because no one has ever carried out this
12   exercise and the programme is been running now for so long, without that
13   thorough careful evaluation being done to make sure that what information
14   you get now is robust, it is accurate, smears have been properly read, it‟s
15   hard to see how you can use it as a guide to work on.
16   MR MURRAY:           I do think that we can take account of the National
17   Laboratory Review to some extent. All those underlying concerns are there
18   and because we‟ve recognised them and that of itself is valuable. Just going
19   back to Dr McGoogan‟s evidence that you can also take account of how
20   laboratories practice and that‟s a much easier thing to get a grip on. The
21   value of the Du Rose and work in my submission is that he was able to
22   actually go to laboratories, work out which ones were accredited, when they
23   became accredited, how they practice cytology, did they have a cytology-
24   screeners, did they have qualified cytology-pathologists. So that you‟ve got
25   some base information about what New Zealand laboratories were doing
26   and in the early part of the decade, the practice seems to have been variable
27   and questionable and TELARC accreditation wasn‟t in place. From 1996
28   on, you get a level of comfort that laboratory performance had improved or
29   should have improved because the quality requirements were in the
30   laboratory. Now what we don‟t know is the extent to which those quality
     28/9/00                           C/ 884

 1   improvements completely remove the risk, they would never have removed
 2   the problem of false negatives. I think that would be a given. So you‟re left
 3   with but is there still an unacceptable level of underreporting?
 4   CHAIR:     Yes but we do what is the correct benchmark to determine that at
 5   the moment? How do we know for sure that the point 5 or the point 6 or
 6   whatever correct because you really have to look at what your cancer rates
 7   and work out what you expect the rate of underreporting to be here of
 8   abnormals. If you‟re going on the historic information, if that historic
 9   information is inaccurate, it‟s going to give you a false picture for the future.
10   All the research papers show that the best way of picking up whether a
11   screening programme is working is the clinical audit because then you‟ve
12   got the woman with cancer, you go back and you look at her treatment and
13   you say well why wasn‟t it picked up. If you find that the smears have been
14   wrongly read, if you find she‟s got say five normal smears and then she‟s
15   got invasive cervical cancer, that may trigger an alarm bell, you can then go
16   and look at the slides and do a slide reread. You only need to do that sort of
17   audit once or twice to pick up that maybe you‟ve got a problem with a
18   particular laboratory in a region because if it has happened say for three
19   women, you may say well how come this is happening? Is it happening for
20   more and you then need to look further. But until you do that intensive type
21   of exercise, you can be quite mislead by saying yes this laboratory is
22   TELARC accredited, yes it‟s reporting rates are in line with what we think
23   is an acceptable benchmark. But you have to say to that well without real
24   knowledge of what is going on, so what.
25   MR MURRAY:           I want to come to Professor Duggan‟s question I think
26   which is so why wouldn‟t you start the whole programme again now and I
27   think that it picks up that analysis that there is two things that are critical to
28   this. One is the report of this inquiry about systemic problems, historical
29   and current. The second is the completion of the Cox Richardson National
30   Evaluation.
     28/9/00                           C/ 885

 1   CHAIR:     Is that going to do a slide review or…
 2   MR MURRAY:           As I understand that is now being looked as, yes it‟s
 3   going to be a variation to the protocol.
 4   CHAIR:      Yes because it seemed if you were going to do a clinic audit of
 5   women who had got invasive cervical cancer, that wasn‟t enough to go back
 6   to their GP records. You would want to make sure that earlier smear tests
 7   that were said to be normal did check out as normal and that wasn‟t a
 8   problem with the laboratories.
 9   MR MURRAY:           I think that evaluation on my quick reading on it and
10   Professor Duggan will quickly correct me if I‟m wrong here was more
11   focused on programme issues than women issues, than individual women
12   issues. I might be wrong there. But if you then put a slide review exercise
13   on top of it, you then I believe have the ability to find out whether negative
14   reports were false negatives or true negatives. Assuming anyway that that
15   evaluation is scientifically correct and that slide review is necessary and that
16   the slide review established is false negatives and therefore exposes all the
17   women in New Zealand who need follow up, you then have the answer to
18   that historic problem. I‟m not sure that the focus of that work is directed at
19   identifying individual women for treatment, I think it‟s actually the other
20   way, it‟s identifying women who have got cancer and going back and saying
21   how did that come about given that they were on the screening programme
22   and therefore you have to fix it for the future.
23   CHAIR:     Well that would involve certainly looking at their slides wouldn‟t
24   it because if you‟re saying how did it come about given that they were on
25   the screening programme, one possibility is that their earlier smear tests
26   were misread.
27   MR MURRAY:           Yes but there‟s two issues here. It may be too late for
28   those women who have got cervical cancer and …
29   CHAIR:       Yes but we‟d need to know if there was a laboratory reading
30   smears wrong because there could be other women out there who‟s smears
     28/9/00                           C/ 886

 1   had been read by the same laboratory who had abnormalities that hadn‟t
 2   been picked up but they hadn't progressed to the stage of having invasive
 3   cervical cancer , they weren‟t showing any demonstrable systems or signs.
 4   And you‟d want to get those women early before they progressed to
 5   invasive cervical cancer.
 6   PROFESSOR DUGGAN:             Mr Murray, I‟m actually going to help you here
 7   because I accept what you‟re saying that in terms of the individual women
 8   this exercise does not help her but this exercise is invaluable to the
 9   programme in terms of identifying areas of deficiency in the programme and
10   establishing the benchmarks.
11   MR MURRAY:           That‟s what I was trying to say in a far less sysinct and
12   correct manner.
13   CHAIR:       Well I wasn‟t saying the clinical audits are done to help the
14   woman because I too can see the woman‟s got invasive cervical cancer, the
15   clinical audit is done to find out what went wrong in her treatment, be it on
16   the programme, be it the GP, whatever. The whole purpose of finding out
17   what went wrong, putting aside the woman and how she might like to know
18   is so you can ensure that it doesn‟t go wrong for another woman in the
19   future or that there aren‟t women out there who have been subject to the
20   same errors but who don‟t know and you want to pick that up.
21   MR MURRAY:           I think that must be right. I think where we‟ve got to
22   though is we‟ve got a Du Rose study which is not a scientific clinical
23   evaluation so it was just a risk assessment, a snapshot in time, are there any
24   other Dr Bottrill situations out there.
25   CHAIR:      It depends what you call a Dr Bottrill situation. If you call a Dr
26   Bottrill situation a situation with a man working on his own, isolated area,
27   not TELARC accredited, the answer is no.
28   MR MURRAY:         That was the immediate focus.
     28/9/00                          C/ 887

 1   CHAIR:     If you say a Dr Bottrill situation is a generic term for a situation
 2   where you‟ve got a laboratory that‟s underreporting in a systematic way,
 3   you don‟t know, we don‟t know.
 4   MR MURRAY:         But you can say from 1996 on, the laboratories appeared
 5   to have or actually do have accreditation and the usual things you expect
 6   that laboratories practicing at a high standard. So then the next thing you
 7   have to do is get the gold standard if you want to be sure and that might
 8   show up, I mean we‟re focusing on laboratories but it might show up a poor
 9   level of smear taking or something as the cause for a problem in a particular
10   part of the country. So that‟s a different exercise, but if it‟s done, it gives
11   you a more reliable basis for finding actual problems that may have affected
12   the problem historically during that ten years.
13   CHAIR:     Well my concern is I‟ve been lead to believe that the four region
14   study which I thought was necessary to enable us to answer term of
15   reference 3 in the sense that it would enable us to know with any certainty
16   whether there were other systemic issues in relating to laboratory
17   performance. Because there could be laboratories out there not like the Dr
18   Bottrill laboratory that was still underreporting and I‟d been lead to believe
19   that the National Evaluation was going to be an exercise that would pick that
20   up. And that in view of your concession that there are systemic problems
21   we don‟t need the four region study to answer terms of reference 3,
22   therefore we can be satisfied. As I understand the evidence at the moment,
23   we simply don‟t know what‟s out there.
24   MR MURRAY:          I think that must be a given that the inquiry can only do
25   what it‟s asked on its terms of reference and that may well be a result of this
26   report and that‟s what the Health Funding Authority‟s position was too.
27   They could not say for certain after doing the Du Rose National Laboratory
28   Review that there were not some women out there at risk, they could not
29   give that guarantee.
     28/9/00                           C/ 888

 1   CHAIR:       Well our four region study, given that we‟ve picked two areas
 2   that was going to be narrowed down to three, given that there were two
 3   areas where there was a high rate of invasive cancer might well have
 4   identified whether or not there were other laboratories put there performing
 5   in a manner similar to Dr Bottrill‟s in the sense it was underreporting.
 6   MR MURRAY:           Yes it might have but of course we don‟t actually, we
 7   know there‟s one and we know what systemic issues have come out of that.
 8   So for the sake of the inquiry we could go and say if we find another area,
 9   that will add weight to our report…
10   CHAIR:      To our systemic issues.
11   MR MURRAY:          Systemic issues assessment but we don‟t need to do that,
12   we‟ve heard there have been so many systemic issues identified.              My
13   concern in fact would be that holding up the report to do a case study on
14   another area may actually undermine the objective we‟re trying to achieve
15   which is to report on the systemic issues identified and make sure they‟re
16   resolved.
17   CHAIR:      Well if the report were to say something to the effect that on the
18   evidence before the Committee there are certainly systemic issues, systemic
19   issues relating to laboratory performance and the reading of cervical smears,
20   that on the evidence we‟ve heard there is nothing to suggest to us that the
21   problems were limited to Gisborne. That for all we know there could be
22   other laboratories out there who have in the past and in the present
23   underreported smears and there could be women walking around
24   abnormalities that they are unaware of because they‟ve had a false assurance
25   of a normal smear test. Until a thorough evaluation of the programme
26   including a clinical audit is done, that state of affairs can‟t be ruled out. And
27   given the health risk involved, one should assume the worst.
28   MR MURRAY:         I think that would have to be balanced by reporting…
29   CHAIR:      I know it‟s quite strong. I mean if you don‟t know, if you have to
30   say we don‟t know what‟s out there, there could well be underreporting out
     28/9/00                           C/ 889

 1   there of a significant level, we just don‟t know. If there is isn‟t well then all
 2   well and good but if there is, women are at risk, there are women at risk
 3   now, there are women who could become at risk in the future and given the
 4   dire consequences that will attach in a sense it‟s safer for the sake of the
 5   women to assume the worst then to say oh well we‟ll be balanced, we‟ll
 6   hope everything will be alright just as we hope tomorrow will be a sunny
 7   day like today, there won‟t be another storm.
 8   MR MURRAY:         Well I was going to say that if you report on that analysis
 9   you would have to balance it by saying that that analysis is based upon
10   systemic problems we have identified, namely lack of standards and
11   effective monitoring over the ten year period. But you would have to say
12   that the seriousness of those systemic problems were ameliorated by the
13   improvements that were made to the programme during the ten year period.
14   That does not affect your analysis, it just balances, it gives you a risk
15   assessment and it‟s the risk assessment at the end you have to make.
16   CHAIR:      Well look we‟ve gone beyond 11.30 so we‟ll stop here and we‟ll
17   come back at 12 but I would like you to identify very clearly what you say
18   ameliorates the risk because my concern is that is the information is not
19   robust because it‟s never been thoroughly audited. Certainly one could say
20   well if all laboratories are TELARC accredited, they‟re less likely to go
21   wrong but it‟s that level of comfort so I would like to be very clear so I
22   don‟t misunderstand you about what you say ameliorates the risk.
24             INQUIRY ADJOURNS AT 11.42 AM UNTIL 12.00 PM
26   MR MURRAY:          I don‟t think I have come up with anything that I haven‟t
27   already been saying but my submission is that it‟s not just a simple matter of
28   TELARC accreditation and maybe I‟m being too simplistic by just referring
29   to TELARC accreditation from 1996 onwards but if that imports quality
30   assurance procedures that include for example individual laboratory
     28/9/00                          C/ 890

 1   correlations where a woman is diagnosed with cancer and the laboratory
 2   then looks back on its own smears
 3   CHAIR:     But does TELARC do that?
 4   MR MURRAY:           No but if the quality assurance procedures require the
 5   laboratories to have this process…
 6   CHAIR:     Just tell me does it happen at the moment or not and if so, where
 7   is the requirement to be found that forces laboratories to do it?
 8   MR MURRAY:           I think we might have to take a moment to find some
 9   evidence on that.
10   CHAIR:     I don‟t want to rush you it‟s just you see I don‟t have anything in
11   writing from you on systemic issues and I‟m trying to get a good
12   understanding of the Ministry‟s case. I don‟t want to misunderstand it in
13   any way and you have said yes there were systemic issues, a lot of them
14   historic but it has been ameliorated since 1996. What I want to know
15   because I need this for the purposes of terms of reference 4 onwards where
16   we‟re looking at what changes have been made, agreed to be made, what‟s
17   still needs to be done.     I want to know from you what you say has
18   ameliorated matters. Now if you would rather leave that until later in the
19   day because I know you‟ve only had a 15 minute break, that‟s fine but I
20   would like to know precisely what it is and where it‟s to be found because I
21   want to be able to go back and check it out for myself.
22   MR MURRAY:          I just on my feet can‟t think what evidence covered that
23   but if I‟m right, if the quality assurance procedures give you that level of
24   comfort, you would expect that a woman from 96 onwards would have gone
25   to a laboratory twice that had high quality assurance procedures and it
26   would be very, it‟s not impossible of course that both smears could have
27   been false negatives, but you would not expect that to occur in a laboratory
28   that had high quality assurance procedures. And if it happened once, you
29   would say that was unlucky, if it happened twice, it would be highly
30   unlikely. If that approach is right, we are at a situation where the Health
     28/9/00                          C/ 891

 1   Funding Authority‟s decision on risk assessment is correct and I believe
 2   that‟s where we‟re at. What I need to do now is back up that with the
 3   evidence on the…
 4   CHAIR:      Yes if you could back it up. Yes I suppose one thing is if you
 5   look at the pattern of taking smears on a three year basis, if those smear tests
 6   are being read by big laboratories and are doing big numbers, quality
 7   assurance, even if you get a bad cyto-screener in one test who misreads it,
 8   you‟re not likely to go back to the same cyto-screener in the next three year
 9   interval, you will get someone else, you may go to another laboratory. So
10   it‟s that randomness that should reduce the risk but to what degree, there are
11   probably mathematical models one works out to work out these random
12   issues. Putting that aside, I would like to know from the evidence what it is
13   that you now say has improved matters because for the purposes of writing
14   the report, we‟re going to have to say matters have improved or they haven‟t
15   improved and if they have improved, by how much. So I would like to
16   know where the information is to be found.
17   MR MURRAY:          And I suppose if I sense there‟s an underlying concern
18   that the programme was not working, I still come back to where I began that
19   you do see the outcomes of the programme reducing the incidence in
20   mortality from cervical cancer. What you don‟t know is whether those
21   outcomes could be even better.
22   CHAIR:      Well yes but the other thing is what we don‟t know is given the
23   long period of cervical cancer in terms of its development, we don‟t know
24   whether the reductions that we now see are as a result of steps that were
25   taken earlier. We don‟t know if the reductions are just through opportunistic
26   screening, through women leaving the country.              There are various
27   speculations but I‟d asked Dr Duggan about this because it was pursued by
28   her in evidence. You can‟t just say that the rate has dropped because of the
29   programme, it could have dropped for other reasons as well. Also in terms
30   of the targets that have been set, you‟ve got to say well were they good
     28/9/00                          C/ 892

 1   targets, were the targets set right, were they set too high, were they set too
 2   low? In some ways it could be said the fact that they have been achieved so
 3   quickly ahead of time might suggest they were set too low. All I‟m saying
 4   and that‟s really where we get to, it‟s not a matter of saying the programme
 5   is bad, it‟s a really a matter of saying until you have that very good
 6   evaluation that we‟ve read about in the Who Guide documents, the
 7   European Guidelines of the Clinical Audit, it‟s very hard to say is the
 8   programme working well or not. But what we do know is that Gisborne
 9   provides an example where the programme hasn‟t worked well. Whether
10   there is another Gisborne out there in the country that has yet to be
11   discovered we don‟t know, that‟s the problem, we don‟t know.
12   MR MURRAY:        Well that‟s probably as far as I can take it.
13   CHAIR:       If you can point to evidence which provides comfort which
14   would convince us that no it couldn‟t be happening elsewhere, that‟s sort of
15   evidence I would like to hear from you.
16   MR MURRAY:          I think we do need to write up the Du Rose material, I
17   think that‟s where we‟ve been remiss in not getting that far and putting the
18   Du Rose material in context. I believe that the problem is we‟re being
19   referring to the National Laboratory Review for different purposes, it was
20   done for one purpose, it‟s been applied for another purpose. If we can
21   retreat and gather strength and come back with some references even to that
22   material, that would be of some value.
23   CHAIR:      I am in the middle of reaching the termination of whether we
24   have the four region study or not and I thought if we need it to answer term
25   of reference 3 then we need it. If we don‟t need it to answer term of
26   reference 3 you have to stand back and say well why do it. But the problem
27   is my mind shifts all the time because one time I‟m hearing from you, yes
28   there are systemic problems, we accept the Du Rose study doesn‟t give you
29   confidence that there are systemic problems but then you start to say well
30   these issues have been addressed and we can point to the Du Rose study.
     28/9/00                          C/ 893

 1   MR MURRAY:         Yes well that‟s the point that it does two things, I suppose
 2   this is where I started with this submission on that evidence because,
 3   perhaps I should go back to it because it is actually important. There were
 4   four points about it and the first was the isolated case or not issue. I think
 5   on that there was no guarantee that it wasn‟t an isolated case but having said
 6   that, there was no Dr Bottrill situation discovered, no serious example of a
 7   laboratory practicing without quality assurance or cyto-screeners. So you
 8   get…
 9   PROFESSOR DUGGAN:            I‟m disturbed Mr Murray.
10   MR MURRAY:         I hope I‟m not going backwards here.
11   CHAIR:     You are. You‟re rapidly losing ground.
12   PROFESSOR DUGGAN:                   Because there was so much missing
13   information from the early years of the programme, I don‟t think you can
14   actually say that, that there was no example of a Dr Bottrill out there.
15   MR MURRAY:          I think that‟s probably right and it‟s in more the recent
16   period, it‟s the post 96 period where you can say, in fact I think even Mr Du
17   Rose was candid about that, that everything was very unreliable in the early
18   part. More recently from 96 onwards they couldn‟t find any case where
19   there had been somebody practicing like Dr Bottrill. So that‟s point one, the
20   evidence is relevant to an isolated case or not.        Point two it showed
21   additional systemic issues, not only did it not say no isolated case, couldn‟t
22   give you that assurance.      It said there was additional systemic issues
23   identified so you add those to the ones you‟ve already identified. The third
24   thing it did was report on the Health Funding Authority‟s risk assessment of
25   this situation and the Health Funding Authority‟s risk assessment is that
26   having engaged pathologists from around the world and having done various
27   things as set out in the study, the Health Funding Authority‟s conclusion
28   was there was nothing to warrant doing a whole scale slide review in the
29   nature of the Gisborne exercise. There was identification of concerns and
30   there‟s a number of laboratories being followed up with, even to the extent
     28/9/00                            C/ 894

 1   of following identifiable women and going out there and making sure that
 2   their treatment was appropriate. So some limited follow up is actually being
 3   done but overall the Health Funding Authority‟s risk assessment was that
 4   nothing sufficiently serious to warrant a major exercise like Gisborne should
 5   be done.
 6   PROFESSOR DUGGAN:              Mr Murray, I acknowledge what you‟re saying,
 7   I‟d like to ask you to confirm for me whether this statement with regard to
 8   the risk assessment has actually been signed off by the advisory group of
 9   this study.
10   MR MURRAY:           I meant to just check the evidence on that. As I recall the
11   evidence, the material on the laboratories was signed off but the Health
12   Funding Authority‟s conclusion on what that meant was not signed off.
13   CHAIR:        That‟s my understanding.
14   MR MURRAY:           And so what I am submitting is that the Health Funding
15   Authority had that work done, the pathologists advisory group said yes we
16   are happy that we‟ve identified problem laboratories and that the Health
17   Funding Authority‟s follow up of those problem areas is appropriate. And
18   then the Health Funding Authority put its own words on that and said, I
19   haven‟t got the words just here but it drew a conclusion and those words
20   were not signed off by the advisory group. I suppose where we get to is
21   does this panel take, is this panel‟s risk assessment of the situation the same
22   as the Health Funding Authority‟s or not. I suppose on that you can look to
23   the work of the advisory group and Dr Medley of course came over here to
24   try and help us with this exercise. Although you‟re still left with thinking
25   yes well the science wasn‟t quite right, when Dr Cox was asked in evidence
26   well what would you do in a situation like this, he said well I would have to
27   ask the pathologists and of course that‟s what the Health Funding Authority
28   did, it asked the pathologists what do you make of this laboratory practice,
29   what do you make of the problems we‟ve identified, what do you make of
30   the follow up we‟re doing with the six laboratories and they were
     28/9/00                           C/ 895

 1   comfortable that that was appropriate and Dr Medley gave direct evidence
 2   of that.
 3   CHAIR:       I would now like you to just pull out the terms of reference
 4   because it seems to me that the Du Rose study was all about is there another
 5   laboratory operating like Dr Bottrill‟s and it took a very concrete view of
 6   what that meant, namely sole pathologist, no TELARC accreditation, doing
 7   primary screening, isolated environment, I can‟t reel off any others off the
 8   top of my head. It looked around to see if there were laboratories liked that
 9   and decided no and it also picked up that point 5 benchmark and looked at
10   and identified six laboratories. Under terms of reference, we‟re not here to
11   look at are there other laboratories performing like Dr Bottrill, under term of
12   reference 3 we have to say if we think there‟s unacceptable level of
13   underreporting and that doesn‟t mean by a laboratory functioning like Dr
14   Bottrill‟s it just means underreporting generally. If there is underreporting
15   we have to say is it an isolated case, in other words in Gisborne only or is it
16   a systemic issue. So we‟re not really interested in, I mean obviously we are,
17   but the telling factor is not are there other laboratories out there operating
18   like Dr Bottrill‟s and if you can point to no other laboratories, you can say
19   be assured. We‟re concerned to know is there underreporting out there?
20   MR MURRAY:           Yes and I wouldn‟t disagree with that the assessment the
21   way you‟ve put it.
22   CHAIR:     I‟m pleased about that, I‟m trying to pin you down. I‟ve had no
23   written submissions, I‟ve had no ability to prepare on this, it‟s very tiring at
24   the end of the inquiry to have to deal with this.
25   MR MURRAY:            It‟s tiring for me trying to respond too. Maybe it‟s
26   valuable to do it this way because I think we‟re making progress…
27   CHAIR:      Can I on behalf of my two colleagues give an oral report to the
28   Minister on 20 December?
29   MR MURRAY:           I think that would probably be accepted. I just want to
30   pick up on that point because although your assessment of that term of
     28/9/00                          C/ 896

 1   reference 3 is right on my analysis as well, you can still say when you do the
 2   risk assessment well we can get some comfort from the fact that we didn‟t
 3   find any other laboratory practicing at such a poor, having such poor
 4   methods. I think at the end of the day you do have to make these judgement
 5   calls, it‟s the balance one strikes. If the National Laboratory Review had
 6   shown up three other laboratories working like that during the 91 to 96
 7   period, you‟d have even greater concerns. Then if you found one of those
 8   laboratories had carried on practicing through the late 1990‟s like that, well
 9   of course your risk assessment would be different. You would say well the
10   Health Funding Authority can‟t possibly say that further action to identify
11   women is not warranted. But we‟re not in that position, I believe we have
12   made on the evidence that we‟ve had given all the variables in cytology and
13   all the debates about the science of the studies, I do believe when you stand
14   back and take a commonsense approach, you get a level of comfort that the
15   Health Funding Authority‟s risk assessment is probably right and that
16   there‟s a stepping stone into standards that would be regarded around the
17   world as appropriate for a screening programme.
18   CHAIR:      Well I‟m not advocating a rereading of slides of all women in
19   New Zealand because in a sense that would be a possibility because you
20   couldn‟t really pick particular areas, I mean that was your point about the
21   four region study. Why is it these four regions, it could be others, you
22   would have to look nationally. What does concern me is that and I come
23   back to what I‟ve read that this clinical audit is the gold standard for finding
24   out if there‟s underreporting. It‟s never happened, not only has it never
25   happened but at the moment on the current state of the law as at September
26   2000, it can‟t be carried out unless you get the consent of the women
27   concerned. When that audit is carried out that in a sense may alleviate
28   concerns about underreporting because that audit looking at women who
29   have developed cancer going back to see what does their smear history
30   show, were they correctly read or not as part of the audit, it‟s not all of the
     28/9/00                           C/ 897

 1   audit but it‟s part of it. Will then completely allay doubts people will know
 2   where they stand but until then, you really are in a situation where you could
 3   say yes things seem to be okay but then have an audit and have everything
 4   blow up in your face. If you look at the discussion Dr Teague and Dr Tie
 5   had with Tracey Mellor, it seems, I say seems because they‟re not here
 6   making findings as such, but it seems that they truly believed that they were
 7   looking at an isolated case that it was just the false negative, that you could
 8   have these problems. No one actually realised the magnitude of the problem
 9   until the Sydney reread was carried out and that came as a surprise probably
10   to a large number of professionals who probably thought yes there‟s a
11   problem but could never have imagined it would have been as big as it was.
12   With that type of knowledge, I am very concerned to say well in the face of
13   no direct information, it‟s alright to assume that things are probably okay
14   now because laboratory practices have improved therefore they‟re probably
15   alright. It‟s very like saying I‟m looking at a false negative here.
16   MR MURRAY:             I don‟t think we‟re arguing that you should give
17   assurances that the evidence doesn‟t support and I think the value of the
18   inquiry‟s report is to document the absence of a National Evaluation in all
19   the regions of New Zealand for all the women who have contracted cervical
20   cancer even though they‟ve been on the Register or not as the case may be
21   because that‟s important. The value of the report as it documents that and
22   puts the onus back squarely on those who manage the programme to ensure
23   it‟s done and it‟s just the inquiry can only achieve so much.
24   CHAIR:      I understand that all I‟m trying to do now is test and challenge
25   everything you say so that you‟ve got, and I‟m not saying what I‟m
26   expressing to you now are my firm views on the matter at all but I see they
27   seem to me at the moment as I hear your argument weaknesses in it and I‟m
28   challenging it to give you an opportunity to respond to it so I can go away
29   later and read through everything and then come to a conclusion.
     28/9/00                          C/ 898

 1   PROFESSOR DUGGAN:             Mr Murray I would like to say with regard to
 2   the terms of reference of the inquiry clearly we are bound by those but at the
 3   same time we all function on the certain moral level. And I‟m not being
 4   facetious when I say this that my own internal morality forces me to go
 5   beyond the terms of reference and express concern for the women and the
 6   programme.
 7   MR MURRAY:         And I don‟t think any of us who have participated in this
 8   inquiry have felt any differently and I suppose where we end up though is
 9   we‟re using lawyers and legal techniques and procedures to resolve the
10   problem. And I suppose as a lawyer I have to make this submission that I
11   understand that and I realise that the pressure is greater on inquiry panel
12   members even more so that those who are on the other side of the table here.
13   But that at the end of the day the power that you have is to write a report
14   that does not create undue concern because it‟s excessive concern but does
15   not understate the magnitude of the problems discovered. That‟s why I
16   started off the submission with the balance that has to be struck, the need for
17   an objective tone, an objective approach to the analysis so that we end up
18   with an authoritative report that people will say clearly this has got to be
19   acted upon. The moral responsibility is recognised it‟s just the legal process
20   traps us into doing it a certain way and then putting the pressure back on to
21   those who run the programme. I think that tension is probably understood
22   more with lawyers because we know the process we‟re locked in, we‟ve had
23   to go over to some medical concepts and I think what you‟re finding is
24   you‟re finding the tension of being locked into an inquiry process bound by
25   terms of reference. Having said that, I do believe that the terms of reference
26   are drafted in quite an open ended way particularly towards the end. The
27   inquiry does not need to feel inhibited that if those concerns about women
28   are based on evidence that you have heard and they need to be addressed
29   they can be written up in the report and even to the point if the evidence
30   goes far enough or the expertise of the panel goes far enough to identify the
     28/9/00                            C/ 899

 1   action that should be taken and that‟s a judgement call, it‟s not just the
 2   evidence inquiries like this are appointed and proceed on the basis that the
 3   panel members have expertise that brings value over and above the evidence
 4   itself. Obviously you base it upon the evidence but your expertise is applied
 5   to the evidence. I think although we‟re in a legal process I don‟t think it
 6   need inhibit what you would want to report.
 7   CHAIR:       We understand that the findings and conclusions etc of the
 8   committee have to be based on evidence, I mean that‟s the principle from
 9   Erebus when we see that what I‟m trying to explore with you and Dr
10   Duggan is to is to say well what does the evidence show because there may
11   well be different views on the evidence and one person may take a view that
12   the Du Rose study particularly the Health Funding Authority‟s risk
13   assessment is sufficient to allay doubts. Another person looking at matters
14   may say well no we don‟t think it is and it‟s really that difference of opinion
15   in terms of inferences drawn from the evidence which we were trying to
16   explore with you.
17   MR MURRAY:           It‟s not easy. If there‟s one truism here it‟s that screening
18   programmes are highly complex and that cyto-pathology has so many
19   variables in it that it‟s a challenge to find some bedrock and be definitive
20   about conclusions.
21   CHAIR:     I think you‟ve hit on the point there because this is what concerns
22   us in terms of a, I‟ve stolen Dr Duggan‟s line, the lack of solid foundation or
23   in your words, the lack of a bedrock, as I see it, in terms of information
24   about laboratory reporting. And without that firm bedrock, it‟s very hard to
25   be clear as to how accurate is the laboratory reporting.
27   MR MURRAY:            I do think that the McGoogan evidence may give us a
28   way out.     I recall that her evidence was that this is internationally a
29   problem. You can pick up a benchmark for abnormalities for a particular
30   jurisdiction but whether you're picking a good one or whether it has any
     28/9/00                           C/ 900

 1   basis is always going to be open to debate. So that internationally there's a
 2   problem with benchmarks and cytopathology, I think is her evidence.

 3   CHAIR: I'm sorry, I've led you astray. I don't mean the lack of specific
 4   benchmarks which you tick off and say – you know, is your specificity rate
 5   X, is your sensitivity rate Y? What I'm saying for the lack of foundation is
 6   it seems to me in order to know where you're going with the programme
 7   you've got to have good solid data which tells you what the programme has
 8   been.     In fact, I recall reading the European guidelines and they actually
 9   said ideally you should have good solid data about the situation before the
10   programme so then you're in a good position, you get that data and you
11   build up from it and that allows you to get a good picture of what's going on.
12   There are the 17 tables on the European guidelines which suggest that
13   you've got all this information, you're then in a very good position to be able
14   to look at how is your programme working, and because that hasn‟t
15   happened here, because that information has never been properly gathered
16   and assimilated and made use of, partly because you say that the focus was
17   all up the front rather than the quality assurance monitoring and evaluation
18   part as well, and because of the legal impediments as well, it hasn‟t
19   happened. Therefore, it‟s almost like you're starting with a new programme,
20   in a sense, with the Peters material putting benchmarks, etc., in place. But
21   to me, when you get down to laboratory reporting, you probably know as
22   much now as you would have known 10 years ago. That might be going too
23   far, but –

24   MR MURRAY:          I don't think Mrs Sholtens will let you get away with that.

25   CHAIR: I see, that‟s good.

26   MR MURRAY:          Because of the evidence.

     28/9/00                           C/ 901

 1   PROFESSOR DUGGAN:                Probably in terms of process standards not
 2   much has changed in 12 years. I'm mindful of the American Society of
 3   Cytology/Fitzgerald standards.

 4   MR MURRAY:        Oh, yes.

 5   PROFESSOR DUGGAN:             Stolen, of course, from the Canadian Society of
 6   Cytology.

 7   MR MURRAY:            Yes, I remember that evidence, and adapted for New
 8   Zealand conditions.

 9   PROFESSOR DUGGAN:             And adapted, right. Not much has changed in
10   terms of process standards.

11   MR MURRAY:        No.

12   PROFESSOR DUGGAN:             But I will wait to hear what Mrs Sholtens has to
13   say.

14   MR MURRAY:            Well, I‟ll sit down but I will see if I can find some
15   evidence on the quality assurance procedures. Mrs Sholtens may have that
16   in her head.


18   CHAIR: Certainly from the material I've read – this is the Cox exhibits of
19   the European guidelines and the World Health Organisation article on
20   running screening programmes from 86, they both say that quality of
21   laboratory smear reading is pivotal to the success of a programme, and that
22   is something that should be carefully monitored and evaluated from the
23   beginning. In fact, you ought to know how things are before the programme
24   starts up, but it‟s something that you've got to be keeping pace with from the
25   very beginning because if you don't have that then the programme will fall
26   down, and of course that‟s right because you can enrol large numbers of
27   women on the programme and you can have smears taken beautifully and
     28/9/00                            C/ 902

 1   you send them off and you can have all the coding right and everything else
 2   but if they're not being read correctly the programme is going to have
 3   serious difficulties.

 4   MR MURRAY:              I will sit down at that point and pass over to Mrs
 5   Sholtens.


 7   MRS SCHOLTENS:             I thought it might be useful to start on that point
 8   about quality assurance and laboratories and what evidence we have got
 9   about the last 10 or 12 years, and I do think this is something that we should
10   write down for you and trace through the evidence. I have got a little bit of
11   it in my head at least and maybe it would be useful to try and clarify the
12   position because it is so fundamental.

13   CHAIR: I don't mind. You can do it twice if you like. You can do it now
14   and then come back with a written version. I just want to make sure that
15   I've got a firm understanding of what you say are the factors that have
16   ameliorated things.

17   MRS SCHOLTENS:            Yes, and I can see that this is at the heart of the task
18   that you're trying to deal with, so perhaps now‟s the best time to try.

19   CHAIR: Right.

20   MRS SCHOLTENS:             Can I say I think there are two streams of quality
21   assurance relating to laboratories that the evidence covers.         One is just
22   quality assurance that‟s at a general level that laboratories have perhaps just
23   taken on voluntarily, and, for example, the Canadian Cytology Standards
24   that we refer to as the Fitzgerald Standards in 1986 which –


26   PROFESSOR DUGGAN:              Could I say at this point that it was incorrect of
27   me to say that they were stolen – I don't know how they got those.
     28/9/00                          C/ 903

 1   MRS SCHOLTENS:           No, that wasn‟t treated as an allegation. That was
 2   the New Zealand professional organisation adopting standards for its own
 3   internal practice. One can assume, and obviously the government did not
 4   have standards in place or check this, but laboratories were setting their own
 5   quality assurance measures there and the correlation of cytology and
 6   histology is an issue that‟s addressed in those Fitzgerald standards which are
 7   in Boyd 19.    In those late 80s documents, or mid-80s/late 80s documents
 8   where, for example, the Cancer Society and the Ministry of Health are
 9   looking at a screening programme pre-Cartwright, cytology/histology
10   correlation is something that they see as significant and important.


12   CHAIR:     Yes, would you say – my reading of the documents is that that
13   correlation was seen as important from the very beginning.

14   MRS SCHOLTENS:             Yes, I would agree with that.      It was seen as
15   important by both the programme advisers and operators and it was seen as
16   important by the professional organisations, so both streams – the
17   programme quality assurance stream and professional quality assurance
18   stream saw that as important. And so when we‟re looking at what have
19   laboratories been doing over the last 10 to 12 years, I think the evidence is
20   that‟s been seen as important, and I know that only takes us so far.

21   CHAIR:     Yes, because it seemed to me also, given that you've admitted
22   everyone – the programme operators, the professionals, all saw the
23   histo/cyto correlation as important.

24   MRS SCHOLTENS:          Yes.

25   CHAIR:     The way the programme was set up initially didn't allow it to
26   happen. 93, when you get the move to the centralised register, it was then
27   practically possible but you then had to do all the computer re-writing, and
28   my understanding on the evidence is that it hasn‟t become nationally
     28/9/00                            C/ 904

 1   possible until about 96 I think when they finally finished doing the
 2   reconfiguration of the register.

 3   MRS SCHOLTENS:           That‟s almost right as I understand the position, and
 4   I hope – can I take it really slowly because I do see this as very important?

 5   CHAIR: Yes.

 6   MRS SCHOLTENS:          The programme, yes, recognised it as important, and
 7   in terms of, first of all, just setting quality there were two issues: there was
 8   quality assurance within laboratories and there was what the registers could
 9   achieve by way of cyto/histo correlation. And what you've said is basically
10   correct, that when a programme was set up there wasn‟t the ability to report
11   histology – there wasn‟t the requirement or ability to report histology to the
12   register for the programme to monitor that.

13   CHAIR:      That‟s right, and also if it was reported to the register, if the
14   laboratories could have got access to the register, which I understand they
15   can, they could have used the register because the histology, my
16   understanding is, is normally done by the hospital laboratory because the
17   woman goes to the hospital for a colposcopy or a cone biopsy as that‟s
18   where the histology is done, whereas the smear reading is done usually in
19   the community laboratory.      Now sometimes the histology does go to the
20   community laboratory, but unless you've got the histology going to the same
21   laboratory as did the cytology it‟s somewhere else.

22   MRS SCHOLTENS:          You can't correlate.

23   CHAIR: You can't correlate, and my understanding of Dr Boyd‟s evidence
24   is that on an informal basis the professionals did manage to exchange
25   information – who knows how much, but then when the Privacy Act came
26   in that stopped it because then the hospitals were very reluctant to tell the
27   laboratories what the histology results were.      Dr Bottrill apparently said
28   that, but I thought Dr Boyd had actually talked about it in his early evidence
     28/9/00                             C/ 905

 1   too. So you had this situation where the only organised way of making sure
 2   there was cyto/histo correlation was through the register, which if the
 3   laboratories could get to the register they could see it.

 4   MRS SCHOLTENS:             Right.    The Fitzgerald standards in 1988 talked
 5   about developing relationships, yes, with the local hospital – we are dealing
 6   with local laboratories basically – to enable that cyto/histo correlation to
 7   occur, and then the Privacy Act, which was 1993, coincided with the
 8   requirement that histology be provided to the programme.

 9   CHAIR:      That's right, except the configuration of the register probably
10   delayed it. You're probably at a 3 year gap where the old informal systems
11   which were in place, wherever, weren‟t working.

12   MRS SCHOLTENS:            As to that point, I'm not sure how far the evidence
13   goes.

14   CHAIR: We don't know.

15   MRS SCHOLTENS:           No, and I think when you actually look at what was
16   happening, like what TELARC was monitoring, what the Royal College of
17   Pathologists of Australasia quality assurance processes were in the early
18   90s, and beyond 93 cyto/histoo correlation was important and was being
19   done within laboratories. Now whether the Privacy Act got in the way, my
20   understanding is it was only Dr Bottrill who mentioned that as an issue.

21   CHAIR: Yes, I‟ll have to look back through the evidence. It just seemed
22   to me, anyway, there would always be a difficulty in circumstances where
23   the histology was somewhere else.

24   MRS SCHOLTENS:            Yes, there would. And we don't know how much
25   histology was somewhere else. Now we know what the programme‟s been
26   doing for as long as it‟s been able to – which is several years in some cases
27   and not so long in others – they tell the laboratory the results of histology
28   when it‟s read somewhere else but they leave it to the laboratory to do their
     28/9/00                           C/ 906

 1   own correlations when they read the histology for the same woman whose
 2   cytology they‟ve also read.      So that‟s assumed to be done in accordance
 3   with their internal and external quality assurance processes.

 4   CHAIR:          My understanding from Dr Bierre‟s evidence was that a
 5   laboratory could get access to the register, that they had computer access to
 6   the register.

 7   MRS SCHOLTENS:              I didn't pick that up from his evidence.        The
 8   evidence from the Ministry is that they don't at the moment.

 9   CHAIR: Do they get printouts?

10   MRS SCHOLTENS:            Yes, they can ask the local site or the central site to
11   provide them with printouts and that can be done I think – 4 hour turnaround
12   time was Ms Matcham‟s evidence.

13   CHAIR:      So if a laboratory wanted to, it could get regular printouts from
14   the register.

15   MRS SCHOLTENS:           Yes.

16   CHAIR: and given that there is a cyto/histoo correlation on the register it
17   could then have someone go through those printouts to check to see how
18   things matched up?

19   MRS SCHOLTENS:             Yes, and that is expected of them as part of their
20   quality assurance processes.        I think the evidence was that different
21   laboratories ask for different information from the register; there was some
22   standard information that went out, but it wasn‟t the same across all
23   laboratories.    But can I just come back to the histo/cyto correlation point.
24   You are right to say as far as the register, the programme goes, it was
25   required from 93. Laboratories were slow to report to the register. The
26   register couldn't accept the information in an electronic way until 1994, and
27   it took a long time to get that – until 1996 I think – well, even longer – to get
28   that information onto the system, and then until you had the reconfiguration
     28/9/00                            C/ 907

 1   you were still dealing with this unsatisfactory situation of 14 separate,
 2   effectively 14 separate data bases.

 3   CHAIR: That‟s right, so really what do you say to this, then, if we take the
 4   Fitzgerald standards which recognised the importance of a histo/cyto
 5   correlation back in 1988, in 1990 to commence the programme with the 14
 6   registers, which didn't allow for histo/cyto correlation, was itself really a
 7   systemic issue. Well, it points to a defect in the programme.

 8   MRS SCHOLTENS:          Yes.

 9   CHAIR: You accept that?

10   MRS SCHOLTENS:                Yes. I certainly come, when I'm looking at a
11   situation or factors, I think, we have to look at what was feasible and
12   possible at the time.

13   CHAIR: One thing you can help me on, and you don't have to answer now
14   if you would rather have time, because I've struggled to find the evidence,
15   but the bulk of the evidence – in fact I think all the evidence is to the effect
16   that all the experts, all the persons involved in the programme (going back
17   to the Porirua Workshop and before that Professor Skegg‟s ideas) were all in
18   favour of a centralised register.     There was a lot of focus on the World
19   Health Organisation guidelines and a central register. I haven't seen any
20   specific documents where someone is writing saying why it‟s a good idea to
21   have 14 separate registers.

22   MRS SCHOLTENS:          I can deal with that now if you like. I'm still halfway
23   through the cyto/histo thing so I want to come back to that.

24   CHAIR:        All right, well deal with my point and then come back to
25   cyto/histo.

26   MRS SCHOLTENS:           You were told on the last day, the Sunday morning,
27   by the full panel that they'd looked very hard through the documents to try
28   to work out where that initial decision for 14 separate registers came from
     28/9/00                           C/ 908

 1   and they basically couldn't find out whether it was an internal or political
 2   decision, but they could confirm it was made by 1988.

 3   CHAIR: Yes.

 4   MRS SCHOLTENS:            But basically after Cartwright reported, or at that
 5   time it was clear that that was a given.

 6   CHAIR:      Yes, it seems, and if it were an internal decision or if it were a
 7   decision being advocated by officials, advisers, etc., you'd expect to find not
 8   a paper setting out the position but some early background papers weighing
 9   up the two options. You know, 14 registers against 1 register. There is no
10   working document at all that shows that someone was sitting there mulling
11   over this notion of why it was a good idea to have 14 registers.

12   MRS SCHOLTENS:           No, but you can perhaps draw some inferences from
13   the circumstances at the time.        There were pilot registers going, for
14   example, in Otago in 1988 using the same system, the same software, the
15   same providers.     There was this move, and a dramatic change to the New
16   Zealand health system, to Area Health Boards and the devolution.        I must
17   emphasise that this was – I know it‟s obvious – a political decision. There's
18   been a lot of talk about public servants advocating for devolution.     Public
19   servants offer advice and then they do what they're told – they implement,
20   and they had to try and fit this, what was well understood had to be a
21   nationally co-ordinated programme, into a model which was going the other
22   way, which was making the regions, with democratically elected people
23   running those areas, responsible for deciding what the priorities were for
24   health in their area.

25   CHAIR: Well I've got no difficulty with that, I just want to be clear of your
26   position because if we come to the conclusion that all the expert official
27   advice was to go for one register but that it seems there was a political
28   decision because of the devolution in the Area Health Board structure to go
     28/9/00                          C/ 909

 1   for the 14 registers and then set out the problems that created and the fact
 2   that you had to almost start – I‟m u sing the words here of one of the co-
 3   ordinators who was on the panel on the Sunday morning, he said “we almost
 4   had to start again, and having got the programme in place we had to, in a
 5   sense, start redoing, remaking the problem.”

 6   MRS SCHOLTENS:          Yes.

 7   CHAIR: If you are happy with that conclusion, then, you know, I'm happy
 8   with that conclusion too, but before I reached such a conclusion I‟d want to
 9   make sure that I had gone carefully through the evidence to see whether
10   there was some – I don't know – non-political reason, I will call it, for
11   managing a programme with 14 separate registers.

12   MRS SCHOLTENS:           What you've said, there are just a couple of caveats.
13   The first is the nature of the expert advice about whether there should be
14   one central register. I think it‟s pretty clear that all the expert advice we've
15   looked at – the Review Committee, Stratton expert group and then the
16   Advisory Committees, they all were giving advice after the 14 register
17   decision had been made after 88.

18   CHAIR:       Yes, what about Dr Boyd‟s paper in December 88, and
19   Fitzgerald‟s guidelines were in 88.

20   MRS SCHOLTENS:          86.

21   CHAIR: 86, yes. It seemed to me that there was actually material around
22   before 88, or at 88.

23   MRS SCHOLTENS:          Yes.

24   CHAIR:      Which also, if you read it, would strongly suggest a single
25   register. I think the World Health guidelines were around then.

26   MRS SCHOLTENS:            Oh, absolutely.   But I think when you read these
27   reports people will talk about “the register” and mean the 14 separate
     28/9/00                            C/ 910

 1   registers. That happens right throughout those early documents. What the
 2   debate seemed to be focusing on was whether everyone would be required
 3   to use the same software and the same system, which meant many boards
 4   would have to ditch what they had or set up a separate system [tape
 5   turnover] along with the locals.

 6   CHAIR: Yes.

 7   MRS SCHOLTENS:              And so that that could be centrally managed and
 8   linked, there was this concept of, well, you've got the national master patient
 9   index which you can then use. I think there was a perception that it would
10   be easy, everyone would have a number and you'd be able to tell whether
11   somebody had been enrolled on a different register and a different Area
12   Health Board by their number.        Of course the index wasn‟t developed at
13   that level and never was.

14   CHAIR: No.

15   MRS SCHOLTENS:              So I think that if you read those reports, everyone
16   accepts that it was a given there would be 14 registers.      The real concern
17   was that they'd be linked properly and that they'd all have the same software
18   and they'd all follow the same rules, and there seems to have been a debate
19   about that. Certainly, the expert advice was very focused on no, they must
20   all follow the same rules. I think we've referred to Judith Stratton saying,
21   “Well, there‟s ability for some, you know – decide what sort of letters you're
22   going to write”, but –

23   CHAIR: Yes. It seems to me, I‟ll look over the break, but certainly if you
24   take the World Health guidelines and there's a World Health document Dr
25   Cox put forward which came out in 1986 which talks about running
26   screening programmes what you should do, what you need, and a centralised
27   register is what's talked of.       Certainly that was the impression I got,
28   everyone thought there needed to be a centralised register.       But I accept
     28/9/00                            C/ 911

 1   what you say is as you go along certainly people accepted there was going
 2   to be 14 and then they were struggling to ensure that those 14 were
 3   sufficiently co-ordinated to form a centralised register.

 4   MRS SCHOLTENS:           Yes.

 5   CHAIR:      I suppose the concern I have, and your discussion about the
 6   histo/cyto correlation sparked it off, is that‟s one example of something that
 7   people knew at an early stage a register ought to be able to do, and in the
 8   ideal world you would sit down and no doubt draw up a list of all the
 9   objectives that you wanted the register to achieve and then, having looked at
10   what you wanted it to achieve, you would say, “Well, how do we arrange
11   the register so it can do this?”, and it‟s that that‟s missing.

12   MRS SCHOLTENS:             Yes, that's right, this wasn‟t a slow and carefully
13   thought out process. That‟s a clear conclusion I think, we can't argue with
14   it from the evidence.

15   CHAIR: No.

16   MRS SCHOLTENS:            But we also don't know what was possible in 1988,
17   from a technology point of view.          I think the submission refers to Ms
18   Matcham‟s view that it may not have been possible, certainly not at a
19   reasonable cost, to have one database.

20   CHAIR: That‟s the sort of thing I'm saying is lacking. In terms of talking
21   about centralised register, weighing up the pros and cons, you would expect
22   an official‟s paper that put up these ideas and said a centralised database
23   would be good but it can't be done it‟s too costly.        I mean, one can think
24   there was at the time the Wanganui computer which functioned as a
25   centralised database but that was very expensive, so you'd be saying, “Well,
26   for the sake of the programme, this is what it‟s going to cost, it‟s not going
27   to work”, and it‟s that type of decision document which would, therefore,
28   give you an insight into how it came to be that there were 14 registers.
     28/9/00                             C/ 912

 1   MRS SCHOLTENS:                I am sorry we can't help you there.     We have
 2   certainly searched and the earliest Azimuth reports work on these givens
 3   that there will be 14 registers and there won't at this stage be a histology on
 4   that particular register.

 5   CHAIR: I will just look at what Dr Boyd said, you know in that document
 6   of his of December 1988 where I know he‟s recommending a Chief
 7   Executive etc., because that came out of the Porirua Workshop.

 8   MRS SCHOLTENS:                  Yes, those are the recommendations of the
 9   workshop.

10   CHAIR: That‟s right, because that‟s at that 88 period before –

11   MRS SCHOLTENS:               Yes, I don't think you will find anything about the
12   register in that.

13   MRS SCHOLTENS:              What about the Porirua Workshop itself?

14   MRS SCHOLTENS:              My recollection there is that they were working on
15   the assumption of 14 registers as well, but I‟d have to go back and check
16   that. It is certainly something that we've looked hard at to try and find the
17   genesis of it. One can assume it arose from the situation of the pilot studies
18   being in place – you've got something that‟s actually being evaluated so you
19   want to use it, and there's the devolution and the pressure to get this done
20   within 6 months, was the initial decision – or 8 months I think it was. So
21   maybe that was what was behind this, and then it was knitting it all together,
22   of course, which was unsatisfactory, but as Ms Grew said, she got to 1991
23   and she was trying to get opt-on and reconfiguration and histology. Can I
24   just go back before lunch and finish the cyto/histo thing to show you where
25   the programme standards are in any event.

26   CHAIR: Yes.

27   MRS SCHOLTENS:              I guess we've got the 1991 CALC recommendations
28   to TELARC, which TELARC say they effectively accepted and
     28/9/00                          C/ 913

 1   implemented from that point, which is Boyd 22. Those standards said
 2   laboratories should be encouraged to participate to the Royal College,
 3   cytology quality assurance programme. Now I haven't got with me with the
 4   Royal College‟s programme was, that was evidence given by Dr Tie and the
 5   Australian gentleman, Dr Davies, but my recollection is that covered such
 6   matters as cyto/histo correlation.   Certainly, the 91 standards also talked
 7   about the evaluation including quality control within the laboratories.      So
 8   given that an important quality control accepted in 1996 with cyto/histo
 9   correlation, and I think you've heard lots of evidence that that was what was
10   expected within laboratories. Dr Teague said that.

11   CHAIR: So the situation was that it was available in 96 from the register;
12   it was available before that in a sense that the Ministry – well, it was really
13   outside the Ministry„s focus, it was just those laboratories that had chosen to
14   be TELARC accredited because they weren‟t required to be, but those
15   laboratories that had chosen to be TELARC accredited would have found
16   that one of the requirements, you say, they had to meet as part of the
17   accreditation process was to correlate their cytology/histology.

18   MRS SCHOLTENS:          I think that is an inference you can draw at this stage,
19   which is confirmed later, that it was certainly a requirement that TELARC
20   checked.   That evidence is Mr Walker‟s affidavit when he actually came
21   back – as you will recall the 1995 standards which CALC had prepared and
22   until this inquiry we all thought had gone to TELARC and TELARC were
23   accrediting against – that is Boyd 25 – those standards included as the
24   specific at 8.2.2: “there must be a documented system of follow-up for
25   correlating the results of cytology with relevant histopathology”.

26   CHAIR: That‟s at Boyd 22?

27   MRS SCHOLTENS:          25 for the 1995 standards, and it‟s at p51.
     28/9/00                           C/ 914

 1   CHAIR: Just so that I am sure, I want to make sure I've got this. I've got
 2   the 91 recommendations in front of me. Now those 91 recommendations,
 3   so far as I can see they don't require histo/cyto correlation?

 4   MRS SCHOLTENS:            No, they require or refer to – at the foot of the left
 5   hand column – “encouragement to participate in the Royal College of
 6   Pathologists of Australasia cytology quality assurance programme.”

 7   CHAIR: and you say that the cyto/histo correlation was part of the Royal
 8   College of Pathologists of Australasia programme?

 9   MRS SCHOLTENS:           I‟ll have to check that, but that was my recollection.

10   CHAIR: Well, counsel assisting is saying no. Could you please check as
11   we have to be precise.

12   MRS SCHOLTENS:            We will check that.     It‟s relevant though, too, as
13   another point in answer to the question you put to Mr Murray earlier, but
14   that quality assurance was still a requirement – other form of quality
15   assurance was still a requirement, whatever that quality assurance process
16   was.

17   CHAIR:      Whatever it was, it was a requirement if you were TELARC
18   accredited, which was a voluntary –

19   MRS SCHOLTENS:           Which was a voluntary, but we do know how many
20   laboratories were. So when you are assessing the risk, you know, and you
21   know which ones they were.

22   CHAIR: What we need to do now is we need to know – in terms of what
23   we‟re getting back to is this risk assessment of the HFA, so we say, okay,
24   we look at how many laboratories were TELARC accredited, what were the
25   standards they were complying with, or the recommendations they were
26   complying with through the history, and we take that into account in
27   evaluating our risk assessment.
     28/9/00                            C/ 915

 1   MRS SCHOLTENS:          Yes, I guess that‟s the way.

 2   CHAIR: Okay, that‟s fine. Well it‟s five past one.

 3   MRS SCHOLTENS:          Would you mind if I just finish before I lose the trail.

 4   CHAIR: No, you just tell me when we can finish.

 5   MRS SCHOLTENS:           Nearly there. The 1995 standards that we thought
 6   went to TELARC, and are at Boyd 25, p51 is the specific cyto/histo
 7   correlation point, but of course there are other quality control standards
 8   there on p50, for example.

 9   CHAIR: Yes, I see, bottom of p50, “internal quality control” – 8.2.1.

10   MRS SCHOLTENS:          Over the page, p8.2.2 is the specific. Now what Mr
11   Walker, in his affidavit, said about these standards in paragraph 8 – and this
12   is his affidavit on 7 August – was that while they didn't receive this
13   document, or at least had no record of receiving it, they did, it says:
14   “laboratories have been indirectly or directly assessed against some of the
15   criteria contained in the document”, and then he lists them, and he lists quite
16   a large number, but including all the quality control standards in standard 8,
17   although 8.1.3 he says it‟s a 10 year period that TELARC require rather than
18   a 2 year period.   So what that shows us, Madam Chair, it is submitted, is
19   that TELARC have been accrediting laboratories for cytology against some
20   standards which we actually don't have clear evidence of exactly what those
21   standards were. We know they took on recommendations in 1991 and used
22   those, but they had their own group of expert advisors and they applied their
23   own standards and we do know they included a large number of standards
24   from this 1995 document, which is almost exactly the NATA 94 document.

25   CHAIR: Yes. Tell me, did TELARC itself when it gave evidence produce
26   the standards that it was using?
     28/9/00                          C/ 916

 1   MRS SCHOLTENS:           Not for cytology, no.    One wonders whether they
 2   had a particular document because they did seem to rely very much on the
 3   experts going in and assessing the particular laboratory.

 4   CHAIR: It just strikes me as you've got a whole lot of other people floating
 5   around saying what TELARC should/shouldn't be doing. TELARC is the
 6   accreditation body so you would think it would have some control and say
 7   in what standards it was applying. Now we've got this sort of hazy situation
 8   where we've got standards that CALC have developed for TELARC not
 9   clear, it seems they were accepted, but not clear exactly what. But one
10   would think, just so that TELARC itself could be an efficient organisation
11   that worked properly, that somewhere within the body of TELARC, in its
12   offices, there would be a document which were the standards that it used,
13   because when you think about it, there it is going out accrediting
14   laboratories, recording laboratories as being accredited, you would think for
15   its own processes and filing and record system it would have a copy of the
16   standards that were being applied.

17   MRS SCHOLTENS:          Well, I was somewhat surprised when this affidavit
18   came in, which was after they'd given evidence, because you will recall they
19   gave us their high level standards against which they accredited, then their
20   medical laboratory testing standards against which they accredited at that
21   next level of detail down, and they said, you know, there are different types
22   of laboratories, or different units, including cytology. Then they told us in
23   evidence that they accepted various industry groups‟ recommendations and
24   looked at those, and they had their experts that went in and did these
25   evaluations and 4 year audits, and one assumed that we‟d been given
26   everything. They accepted the 1991 criteria were applied. But when they
27   said no, the 1995 standards were not something they were familiar with,
28   they did say, “but, however, we've been applying”, and gave us a whole list.

29   CHAIR: They must have got it from somewhere?
     28/9/00                            C/ 917

 1   MRS SCHOLTENS:            That‟s a gap in the evidence.

 2   CHAIR:     Yes, there is a gap there because given their focus on processes
 3   you‟d think that they would at least have a record of the standards they were
 4   using to decide whether to accredit a laboratory for cytology purposes.

 5   MRS SCHOLTENS:             Yes, and we know, too, that they adopted much of
 6   the national quality, the Sax standards, but that‟s at the higher level as well.

 7   CHAIR:      That's right, it‟s just when it gets down to the nitty gritty of
 8   putting something in black and white it‟s very hard.

 9   MRS SCHOLTENS:              Well, you can be assured at least from Walker
10   paragraph 8 that there's a whole list of standards which are in the 1995
11   document which were being applied, and perhaps not surprisingly given that
12   they were Australian standards and presumably things have filtered across to
13   TELARC – it was an internationally accredited body. So just to summarise,
14   those standards were applying to TELARC accredited organisations,
15   laboratories, and we know all the laboratories – certainly all the community
16   laboratories were accredited by 1996.

17   CHAIR: Well, on this basis, I know now that since 95 these standards, or
18   something very like these standards were being applied, and that included a
19   histo/cyto correlation.    As to what was happening earlier, I know that, in
20   terms of CALC‟s recommendations, a laboratory that was a member of
21   TELARC was to be encouraged to participate in a Royal College of
22   Pathologists of Australasia quality assurance programme. I'm not clear yet
23   what that programme entailed, so I don't know for sure yet whether
24   laboratories who were TELARC accredited before 95 as part of the
25   TELARC requirements upon them had to do a cyto/histo correlation.

26   MRS SCHOLTENS:              If my learned friend says that‟s not part of that
27   process I'm happy to accept that, so, therefore, it‟s not here – although you'll
28   see one of those 91 standards is “appropriate quality control”.
     28/9/00                         C/ 918

 1   CHAIR:     Yes, well, I suppose – I mean, if you are a pathologist in a
 2   laboratory and you see – I mean, if Dr Bottrill happened to see this and saw
 3   “appropriate quality control” that could have different meanings to different
 4   people.

 5   MRS SCHOLTENS:         Absolutely, yes.

 6   CHAIR: Can we have lunch now?

 7   MRS SCHOLTENS:         Please do. I apologise.

 8   CHAIR: No, that‟s fine, it‟s easier to finish the topic off. About 25 past 2
 9   we will come back.



12              LUNCHEON ADJOURNMENT 1.15 to 2.25 P.M.

     28/9/00                           C/ 919

 1                   THE HEARING RESUMED AT 2.30 P.M.

 2   MRS SCHOLTENS:           Now just before lunch we were looking at the 1991
 3   recommendations in Body 22 and just to finish off this bit about what
 4   TELARC required at the time, looking at Dr Robertson‟s exhibits, his
 5   exhibit 2, which is the medical testing accreditation procedures. So we had
 6   that sort of a second level one. We had the laboratory management ones
 7   was the highest level and then medical testing was the second level down.
 8   So exhibit 2 at p24 of that document, and this is a 1983 document. On p24
 9   there's a reference to quality control and what TELARC are looking for.
10   Now obviously this is at the general level and this is the middle paragraph
11   I'm looking at.      There's “internal quality control procedures must be
12   practised in association with each test method, full details of such
13   procedures must be recorded as part of each test method in the laboratory
14   manual”, etc., etc. – the sorts of things you would expect. Then in the next
15   paragraph there's “external quality control – that is participation and
16   proficiency testing programmes is an essential ingredient of good laboratory
17   practice”, etc., etc., “in order to monitor the effectiveness of internal quality
18   control”, and then just a bit further down in that same paragraph, “each
19   laboratory section should have full time participation in at least one of
20   these.”   So it would appear that in their 1983 TELARC standards they
21   would be looking at what quality control procedures were in place and
22   would presumably be requiring full time participation in their external
23   quality assurance procedures.

24   CHAIR: Yes, well, there are two issues here: one, how do we know from
25   all of this that histo/cyto correlation was part of the external quality control?

26   MRS SCHOLTENS:           Well, we don't.

27   CHAIR:       So the only thing we can confidently say is after 1995 the
28   standards at exhibit 25 required by virtue of 8.2.2 that there be cyto/histo
29   correlations?
     28/9/00                          C/ 920

 1   MRS SCHOLTENS:            Yes, and I think we call that – I understand that
 2   would be internal quality control, and internal procedure.

 3   CHAIR:     But what you're saying is, well before that, people did have to
 4   belong to external quality control but we don't know whether the external
 5   quality control they may have belonged to involved a cyto/histo correlation?

 6   MRS SCHOLTENS:          In fact, it doesn't look like – it was more in the line
 7   of proficiency testing, but what I am saying is they had to have documented
 8   internal quality control procedures that were appropriate for the unit that
 9   they were being accredited in, and we know that in 1986 the New Zealand
10   Society of Cytology saw histo/cyto correlation as important and that that did
11   seem to be in – I certainly accept, and I can see that this is not a nice tidy
12   standard, but I'm really trying to indicate what evidence is there so you can
13   take what level of assurance from that as you see fit.

14   CHAIR:       You say:    “I take the 83 document which says you must
15   participate in quality control, both internal and external. I take the 86
16   Fitzgerald standards, which talks about quality control and the histo/cyto
17   correlation, and draw an inference that pre-1995 a TELARC accredited
18   laboratory that was complying with TELARC‟s requirements for quality
19   control is likely to have carried out histo/cyto correlation because that‟s
20   recognised by the Fitzgerald guidelines as a good means of quality control”?

21   MRS SCHOLTENS:          Yes, I think, given time, I could probably also point
22   to evidence that you've heard from different pathologists and practitioners
23   that this was a routine method of internal quality assurance.

24   CHAIR:     There's one problem with the thesis you've presented and that is
25   that histo/cyto correlation is very good at identifying false positives because
26   what happens is you get the histology because someone has been, as a result
27   of the smear test, sent off for a colposcopy, they're seen as being abnormal,
28   so you get the histology, and when you look at it, it either fits with the
     28/9/00                          C/ 921

 1   smears, in which case your smear is accurate, or if it doesn't fit with the
 2   smear because you've over-called the smear – and there was an example we
 3   heard from Ms Gibson of Dr Bottrill reading a smear as high grade III,
 4   another laboratory as invasive carcinoma and then the histology showing
 5   high grade III. So it shows you that. So it helps you with over-reporting
 6   and false positives, it doesn't help you to identify false negatives because
 7   there the person is read as being normal and they just go out into the public.
 8   I had wondered, could you extrapolate that if someone is reading false
 9   positives they're likely to be reading false negatives?    But we know, for
10   example with Dr Bottrill, that he didn't read many false positives.    If you
11   did a histo/cyto correlation in Dr Bottrill‟s work, he called the positives
12   pretty well.

13   MRS SCHOLTENS:         Yes.

14   CHAIR: So that wouldn't alert you to a problem of under-reporting.

15   MRS SCHOLTENS:           Well, you would know more than I do, but I had
16   understood that the histo/cyto correlation might also indicate false negatives
17   because you might get histology results when somebody has been identified
18   as having cancer and then you would go back and look at the previous smear
19   history.


21   PROFESSOR DUGGAN:               Unfortunately, Mrs Sholtens, the only
22   pathologist who told us that they did that was Dr Bierre, that in their
23   laboratory set-up, because they are a community laboratory as well as doing
24   hospital laboratory work, they have access to the histology of women who
25   have invasive cancer and they do a look-back. But I have not seen that in a
26   document anywhere, in any of the documents that you've made reference to,
27   with this being a standard or routine practice, or even a recommended
28   practice. It‟s not in the Fitzgerald documents to the best of my knowledge.
     28/9/00                           C/ 922

 1   I appreciate that you have studied that document in depth, so it‟s not there.
 2   So the cyto/histo correlation that you have been discussing as defined here
 3   in 8.2.2, “there must be a documented system of follow-up for correlating
 4   the results of cytology with relevant histopathology.” So what that implies
 5   for the practising pathologist is when you call cytology abnormal you must
 6   follow it up, and you will follow it up with a tissue or the histopathology
 7   that is subsequently obtained. So you are correlating abnormal results with
 8   histology.

 9   MRS SCHOLTENS:           Right, thank you.

10   PROFESSOR DUGGAN:              The converse is, which is actually in the Peters
11   standards now but I haven't seen it any place else, is you take all biopsies,
12   all histopathology of high grade and you do a look-back.              That will
13   demonstrate under-reporting.


15   CHAIR:       It‟s the difference between a look-back exercise and the current
16   cytology which triggers the histology sampling, you see.

17   MRS SCHOLTENS:           Well, I appreciate everything I have said to date has
18   not made that distinction and I do see what you mean. Can I just check one
19   point.    Sandra Matcham produced a report on the register, and it was
20   certainly my understanding that what that showed was areas where it
21   actually highlighted with an asterisk cytology that had been read as negative
22   when the histology was positive.      So that seemed to me to be part of the
23   look-back process that you've just described.

24   CHAIR:       I know the document you mean, but that came very late in the
25   piece – that was about 1997.

26   MRS SCHOLTENS:           We called that a cyto/histo correlation report.

27   CHAIR: But it enables a look-back.       Do you know the document?
     28/9/00                          C/ 923

 1   MRS SCHOLTENS:          I do. It‟s in Matcham volume 2.

 2   CHAIR:      It‟s a very good document but the problem is this is not the
 3   cyto/histo correlation that we've been talking about of laboratories doing
 4   under TELARC.

 5   MRS SCHOLTENS:           So you're looking at the look-back, what you might
 6   call a look-back.

 7   CHAIR:     A look-back will help you pick up mis-reporting but the look-
 8   back only happens by the time the woman‟s developed the cancer, then if
 9   you are feeding the right information back to the laboratories the
10   laboratories should pick the information up and look back over the past
11   smears.

12   MRS SCHOLTENS:          I have to say I thought that was also part of the same
13   internal quality assurance processes and I will need to go back and check the
14   evidence about that. Obviously you've had a good look at it.


16   PROFESSOR DUGGAN:              To the best of my recall I didn't see it in the
17   Fitzgerald documents, and I can't remember the 95 standard.

18   MRS SCHOLTENS:          Well, I was under the impression that the look-back
19   and the histo/cyto correlations were both happening. I wasn‟t sure that there
20   was a distinction between the two of them, but I can see that there is.


22   CHAIR:     I tell you what, I was trying to look at look-back information
23   when Dr Linehan was here the second time because I was trying to see -
24   you know, there was this whole business about how they were doing the
25   look-back at Medlab Hamilton but they weren‟t doing a look-back where the
26   women‟s earlier smears were with Gisborne Laboratories, and I was looking
27   to see what requirement there was, in terms of their processes, to do a look-
     28/9/00                           C/ 924

 1   back and the only thing that we were able to find was their own quality
 2   control manual.

 3   MRS SCHOLTENS:            Yes, and my understanding of that issue was, well,
 4   the look-back for quality assurance processes is to look at their own internal
 5   processes of that laboratory, so, therefore, looking at whatever happened in
 6   the Gisborne Laboratory wouldn't help them with their own internal quality
 7   assurance processes.     But from the programme‟s perspective, completely
 8   different issue. From the individual woman‟s perspective.


10   CHAIR: I think, though, that from what I've read, or the evidence I heard
11   was that the laboratories as part of the quality assurance do do these look
12   backs and if the slides are somewhere else they will ring the other laboratory
13   up and say “have a look.” That was part of the information that I got, it‟s
14   just that it wasn‟t happening with Gisborne because the slides weren‟t so
15   accessible.

16   MRS SCHOLTENS:           I'm still looking for the cyto/histo –


18   PROFESSOR DUGGAN:              I think I've found it – 17, and as we have said,
19   you're correlating the cytology with a subsequent biopsy, not the other way
20   around.

21   MRS SCHOLTENS:           Right. The flags, though, don't they, they also point
22   out a negative smear within the previous 5 years?


24   CHAIR:        I think I've heard some of this, yes the double hashes. That‟s
25   where you get a high grade result with a negative smear within previous 5
26   years.
     28/9/00                           C/ 925

 1   MRS SCHOLTENS:           That's both true positives and false negatives isn't it,
 2   that‟s flagged?

 3   CHAIR: Yes. This is something that the register has been doing, but it‟s
 4   only since it‟s been recently reconfigured that it's been able to do that.

 5   MRS SCHOLTENS:          And once it‟s got the histology on it.

 6   CHAIR: And until then, you're –

 7   MRS SCHOLTENS:           You're relying on the laboratory‟s internal processes
 8   and their ability to communicate with each other.

 9   CHAIR:       Yes, in circumstances where at the moment, and I know we've
10   looked for this, I can't lay my hands on any document which says
11   laboratories should as part of their quality control do a look-back exercise.

12   MRS SCHOLTENS:           I would like to look that up further because buried in
13   the back of my mind somewhere I thought that was something that
14   Fitzgerald covered and I certainly know it‟s been discussed.

15   CHAIR:       What I'm interested to find out is if it‟s in any standards.       It
16   certainly is in the Medlab Hamilton manual, but that could well be
17   something they‟ve adopted for themselves.        I‟d want to know is it in any
18   TELARC standards or any other Royal College, external quality assurance
19   standards.

20   MRS SCHOLTENS:            What you're looking for is whether it‟s sort of an
21   accepted practice of those in the cytology field at the time.

22   CHAIR: At the time, yes.

23   MRS SCHOLTENS:           Which is what I‟m inviting you to do, is to look at
24   what was. Can I take some time to just check that look-back point?

25   CHAIR: Yes.

26   MRS SCHOLTENS:            I‟d certainly take it from the register reports when
27   they highlight both the true positives and the false negatives for histology
     28/9/00                          C/ 926

 1   coming from outside the laboratory that everybody understands the
 2   laboratory will be doing their own checking for whether histology and
 3   cytology is within that laboratory.

 4   CHAIR: Yes. You see, now that we happen to have this document before
 5   us, it really brings home the benefit of allowing your evaluators to have
 6   access to this information because if you look at another – this document
 7   doesn't have page numbers – turn over from the first page. If you look at the
 8   date of birth, 21 June 59, this person from Otago, you will see the double
 9   hashes there.

10   MRS SCHOLTENS:          This is the first page of the report ma'am?

11   CHAIR: Yes. I will hold it up. That‟s the front page, turn over and go in
12   left hand side down, the second one down, and you see the double hashes
13   there.

14   MRS SCHOLTENS:          Yes.

15   CHAIR:     And you see the histology and then the two cytology, and you
16   know from the double hashes that she‟s had a negative smear within
17   previous 5 years and her histology is what? We don't know what the code
18   is so I don't know what the histology has actually diagnosed, but obviously
19   there's an abnormality there.

20   MRS SCHOLTENS:          Yes.

21   CHAIR:      Now if the evaluator had full access to the register, had the
22   woman‟s name, he could look at this and then it would be a matter, because
23   the laboratory is there he‟d have the laboratory‟s identity, he could contact
24   the laboratory, ask the laboratory had it done a look-back or not, if not – I
25   don't know – ask if he could do a look-back, maybe do a slide review to find
26   out whether or not the negative smear within 5 years was accurately called
27   or not.

28   MRS SCHOLTENS:          Yes.
     28/9/00                             C/ 927

 1   CHAIR:         It‟s not that difficult – I mean, it‟s time-consuming, you have to
 2   know what you're doing, but I can certainly see the way that you could do it
 3   and if you started getting odd results you'd no doubt go further and further
 4   down the trail. But it would be one way – I mean, you could sit down with
 5   a whole series of printouts and just go to all these double hashes and think,
 6   well, okay, and follow on from there just to find out how it was working.


 8   PROFESSOR DUGGAN:                 Actually, I'm quite sure Ms Matcham could
 9   give you a cumulative file and you wouldn't have to do it.


11   CHAIR: You could probably search on the double hashes, couldn't you?

12   MRS SCHOLTENS:              Yes, I think you could.    It‟s amazing what can be
13   done, and I don't know whether you need the woman‟s name to do it.

14   CHAIR: Well, it‟s just to go back to the laboratory, you‟d have to say to
15   the laboratory who it was you were ringing about.

16   MRS SCHOLTENS:             Or the NHI number.

17   CHAIR:         Exactly, it could be an NHI number.       Whether that‟s seen as
18   being something that identifies the woman, I suppose it is technically, but –

19   MRS SCHOLTENS:               Yes, of course this information which is held in
20   laboratories, as I understand it, can be disclosed to TELARC when they do
21   their audit.

22   CHAIR:         Yes, I've never gone into how some people can get it and some
23   can't.

24   MRS SCHOLTENS:             I don't think a lawyer‟s crawled over that one yet.

     28/9/00                            C/ 928

 1   PROFESSOR DUGGAN:             I asked Dr Teague about this – I think it was Dr
 2   Teague, and he wasn‟t sure.

 3   MRS SCHOLTENS:          But he‟d never seen, or at least he thought he‟d only
 4   been getting these reports recently and I think Ms Matcham‟s evidence was
 5   no, they'd been going to somebody else in his laboratory.

 6   PROFESSOR DUGGAN:                  And I also asked the representative from
 7   TELARC, “did you look at these reports”, and they said, “not always”. I'm
 8   para-phrasing now, but “not always”. If the laboratory personnel presented
 9   the reports they looked at them, but if they weren‟t presented they didn't ask
10   for them.

11   MRS SCHOLTENS:         Right.

12   PROFESSOR DUGGAN:               Because TELARC is committed to looking at
13   process standards, not performance standards.

14   MRS SCHOLTENS:         Yes.

15   PROFESSOR DUGGAN              This is very important.

16   MRS SCHOLTENS:         Yes.

17   PROFESSOR DUGGAN:              And you can have excellent process standards
18   and dreadful performance standards.

19   MRS SCHOLTENS:          And I‟d like to think that our process standards were
20   improving quite significantly, and what you say about performance
21   standards has been taken on board but at this sort of level, in order to
22   determine whether there's under-reporting or not, it‟s a very sophisticated
23   process and we‟re not there yet.


25   CHAIR: No. To say it‟s a sophisticated process, the sad thing is when you
26   think about this audit that Cox/Richardson are carrying out, which is
27   requiring them to go to the Cancer Register to get information, then go off
     28/9/00                          C/ 929

 1   and look at clinical records of women, if you want to find out if a woman
 2   has – presumably if a woman is diagnosed as having cancer, and cervical
 3   cancer, the histology that results in that diagnosis is recorded on the
 4   Screening Register as well. The Cancer Register will show you the cases of
 5   women who aren't on the register, so you need the Cancer Register to look
 6   at how they‟ve been managed, but for the purpose of the women on the
 7   register (which is about 90% of the population now) really if you searched
 8   on the double hashes you'd be quite some way down the track, in the sense
 9   that you'd be picking up those women who have got positive diagnosis of
10   some abnormality, you could probably once you'd done that, given there are
11   diagnoses codes, you could probably then sort of search on them, cut out the
12   other grades and hone in on the very high grade or the invasive cervical
13   cancer.

14   MRS SCHOLTENS:          Yes, I think that‟s absolutely right.

15   CHAIR:       So to not allow an independent evaluation team access to the
16   register is quite tragic because it certainly is a valuable tool that would
17   expedite the process.

18   MRS SCHOLTENS:          Indeed, yes, and I think now that we understand that
19   problem, and to be frank it hasn‟t be understood until relatively recently,
20   and we can see the concerns – especially those that have been expressed
21   here this morning, there's no question that these problems will have to be
22   fixed.

23   CHAIR:      But I just want to follow this through with you, though. What
24   does      the Ministry think it indicates about the management of the
25   programme that these sort of difficulties that stand in the way of a
26   comprehensive evaluation haven't been fully realised until just recently?

27   MRS SCHOLTENS:          I don't really know the answer to that question as to
28   what the Ministry thinks about that.
     28/9/00                          C/ 930

 1   CHAIR: I don't want to know that. I was trying to be neutral. It seems to
 2   me the reasonable observer, standing back looking at this situation, might
 3   well conclude that if you've just recently come upon this difficulty it means
 4   that until the time you came upon the difficulty no steps had been taken to
 5   do a thorough evaluation.

 6   MRS SCHOLTENS:          Right.

 7   CHAIR:     Now what do you say to what I think the reasonable observer
 8   might well conclude?

 9   MRS SCHOLTENS:           I say that it is clear from the evidence that in terms
10   of doing this national evaluation, which was to evaluate the programme to
11   date, it was only in 1996 that the first steps were taken towards doing that,
12   and it has taken until 1999 for a contract to be signed. Now that‟s a long
13   time, and you've heard all the reasons why it took that long, and I think the
14   Ministry certainly accepts that it was too long.

15   CHAIR: So you accept that it was too long.

16   MRS SCHOLTENS:          It was too long.

17   CHAIR: and also it seems that even though you were looking at doing the
18   evaluation from the end of 96 and you received the Cox/Richardson draft
19   evaluation plan in June 97, there must have been a lot of talk within the
20   Ministry about what should be done looking at reducing the scope of it
21   because of the cost.   It seems that all the way through, it wasn‟t until the
22   researchers actually started trying to do something that the problem came
23   up; in other words, no-one at all saw it beforehand.

24   MRS SCHOLTENS:           I think that‟s one of the things that I do know has
25   surprised the Ministry. Largely the reason for that delay period was – there
26   were two main reasons: consulting, which happened several time – I think
27   there were 3 periods of consultations on different things; and secondly, I
28   can't remember what secondly was – oh, the need to tender at two different
     28/9/00                           C/ 931

 1   stages in the process. Once they decided what they wanted to do, they
 2   couldn't just contract with Cox/Richardson to do it, they had to go out to
 3   tender.

 4   CHAIR: No, I understand that.

 5   MRS SCHOLTENS:            So those two things.     But in all that consultation
 6   with all the various stakeholders and interest groups it didn't occur to
 7   anybody that this was going to be an issue, and sure you might say, well,
 8   wasn‟t it obvious to the Ministry.    No, it wasn‟t, and it wasn‟t obvious to
 9   Doctors Cox/Richardson either. It wasn‟t until the specific protocol was
10   written up that somebody said, “Oh, he wants all this register information –
11   hang on.”

12   CHAIR:      But what it also indicates, I think, is that no-one in the past had
13   been getting the register information, other than Ministry officials, because
14   if others had been getting the register information, or attempting to get it, the
15   problem would have been realised.

16   MRS SCHOLTENS:               Well, I'm not sure.      I mean, we know that
17   laboratories got it. We know smeartakers got it. And I don't know whether
18   there might have been a problem with 74A that was just overlooked or
19   whether that all came within it, but TELARC representatives people saw
20   some reports.     Information has been made available in the past, and
21   obviously can be under certain circumstances under the existing law, and it
22   may have been that we never even would have realised that there might have
23   been legal hurdles in the way had it not been for Ms Peters‟ careful eye over
24   the protocol.

25   CHAIR: Yes, well, it was that and the fact that once the programme moved
26   into the HFA you then had two separate bodies, didn't you, because you had
27   the HFA managing the programme, the register was still with Health wasn‟t
28   it?
     28/9/00                            C/ 932

 1   MRS SCHOLTENS:            No, it was in the HFA but [inaudible]

 2   CHAIR: That‟s right it went to the HFA and so, therefore, given the HFA‟s
 3   independent legal existence, then the difficulty would have become obvious
 4   because as long as it was within Health I suppose people within Health
 5   thought, “Well, this is information within our control, it‟s our information,
 6   we can sort of use it.”

 7   MRS SCHOLTENS:            But of course the legal position was it was still the
 8   Director-General in charge of the register delegated to the HFA.

 9   CHAIR: Yes.

10   MRS SCHOLTENS:            So the legal position hadn't changed but the factual
11   position had and that‟s perhaps what gave rise to the query and further
12   enquiry, and then we've had lots of different legal opinions. It‟s as if it
13   wasn‟t a situation of “I‟ll recognise a problem, get advice, fix it”, it‟s been –

14   CHAIR: Well, you have been offered the opportunity to have it clarified.

15   MRS SCHOLTENS:            Yes. Well, we have found other ways. Certainly,
16   ma'am, I understand that. We just want to get to the end here as quickly as
17   we can and as best as we can. We are trying to do that.


19   PROFESSOR DUGGAN:              Mrs Sholtens can I perhaps help you about this
20   14 register issue. I'm one of these people who actually enjoys reading Ms
21   Matcham‟s exhibits.

22   MRS SCHOLTENS:            I'm pleased.

23   PROFESSOR DUGGAN:                Volume 1, exhibit 1 is the Azimuth report
24   October 1989 to June 1990. In this report there is an appendix R [un-
25   numbered pages], it‟s a history of the register, dated 16 May 1990. Under
26   number 4, “The purpose of the register. The design of the cervical cytology
27   register took into account four main factors: the needs of New Zealand
     28/9/00                          C/ 933

 1   women, recommendations in the Cartwright Report, overseas programme
 2   experiences and proposals for devolution to Area Health Board.”

 3   MRS SCHOLTENS:         Yes.

 4   PROFESSOR DUGGAN:             It might throw some light on why there were 14
 5   registers.

 6   MRS SCHOLTENS:         Yes. That fits with the theory I've got too, doctor.


 8   CHAIR: Well, this is Azimuth in 1990, so it fits but it‟s an outside body‟s
 9   historical view. Although it‟s a short period in time, it‟s not a Ministry
10   document.    So, in other words, it could be right, it could be wrong, but it
11   certainly does –

12   MRS SCHOLTENS:          Yes, although I think Dr Boyd‟s evidence was that
13   there was a lot of input from the Department of Health into the reports that
14   went under Azimuth‟s name.

15   CHAIR: So you accept it‟s likely to be corrected?

16   MRS SCHOLTENS:         Yes.

17   CHAIR: You do, right. Because when you look at the register, the needs
18   of New Zealand women, well, it‟s hard to say whether that would support
19   one register or 14. Recommendations in the Cartwright Report I don't the
20   recommendations were for 14 registers.

21   MRS SCHOLTENS:         It was centrally organised, regionally implemented.

22   CHAIR:       Overseas programme‟s experiences, well I think that the UK
23   experience showed that having series of registers didn't work.

24   MRS SCHOLTENS:         Yes, I thought there was a conflict on the evidence.
     28/9/00                          C/ 934

 1   CHAIR: Yes, if you look immediately above “Purpose of the register”, on
 2   the same page you will see a heading, “Failure of the British cervical
 3   screening programme”.

 4   MRS SCHOLTENS:          Yes, I see that.

 5   CHAIR:       and you‟ll see “no explicitly assigned responsibility for
 6   performance of the programme.              Poor information, co-ordination, in
 7   particular there was no routine way of linking smears taken from the same
 8   woman. Poor quality of statistics or returns.” I think there's something in
 9   the Straton report too, because she writes on how not to organise a screening
10   programme. It‟s just that I know her report might be later but she talks
11   about the UK experience.      We will get Stratton.       Do you know where
12   Stratton is Ms Janes?

13   MRS SCHOLTENS:          Volume 1 of Glackin, tab 4, p206.

14   CHAIR: I think it was Ms Stratton. There's an article about why screening
15   programmes fail. I thought it was her, maybe it isn't.

16   MRS SCHOLTENS:          I thought Professor Skegg had written in the Medical
17   Journal something along those lines.

18   CHAIR: Yes, that's right, the Skegg Report. That came with the Porirua
19   Workshop didn't it?

20   MRS SCHOLTENS:           Yes, no, there was something else.      It is certainly
21   one that we put in in the Boyd/Glackin exhibits.           It‟s either an extra
22   document or something Professor Skegg produced.

23   CHAIR: There's one that I know it talks about why they failed because I've
24   got a yellow sticky on it somewhere.

25   MRS SCHOLTENS:            I do recall reading several different views about
26   registers and how extensive they should or shouldn't be, but it didn't seem to
27   be –
     28/9/00                             C/ 935

 1   CHAIR:        It‟s just I'm trying to go through these points under paragraph 4
 2   “Purpose of register - overseas experiences” just to see what they are, as I'm
 3   trying to exclude the other factors if they can be.

 4   MRS SCHOLTENS:            Presumably they're talking about what came above?

 5   CHAIR:        Yes.   and then “Proposals for devolution”, that seems to be the
 6   only thing that favours 14 registers. It says here, too, over the page in
 7   Azimuth, again on the left hand side, paragraph 7, “Histology register …
 8   that the concept of adding facilities to the existing register to capture
 9   histology information was considered as early as 1988.             It was not
10   progressed at that time by the department because the focus was on getting a
11   cervical cytology register in place as a first step. A histology register was
12   always seen as a possible future addition.”           And then you've got the
13   advantages.

14   MRS SCHOLTENS:            Yes.

15   CHAIR:        And one of the advantages here, it is noted, is “false negative
16   cervical cytology results can be provided”, which of course is what we've
17   seen, but what this shows is that as at 1988 the department was aware of the
18   benefits of doing something like what we saw in the Matcham report,
19   exhibit 17.

20   MRS SCHOLTENS:               Yes.    I think that‟s absolutely clear from the
21   evidence that that was a benefit and I also think it‟s clear that post-
22   Cartwright there was real pressure to getting something up and running, that
23   is why basically you didn't have a carefully planned and staged
24   implementation.

25   CHAIR: Yes.

26   MRS SCHOLTENS:                   Dr Duggan, I think I have finished on
27   histology/cytology and anything way beyond my level of expertise.        Have
28   you? May I move on?
     28/9/00                          C/ 936

 1   PROFESSOR DUGGAN:            Yes, I go back to it actually.

 2   MRS SCHOLTENS:          Yes, I go back to the Commerce Act.

 3   PROFESSOR DUGGAN:               I just would have one comment about that.
 4   You have shown with Ms Matcham‟s exhibits that laboratories got this
 5   information but there didn't seem to be any consistent methodology for
 6   laboratory providers to use in terms of determine there calculations. It was
 7   left up to laboratories to look at this data and determine their own
 8   performance.

 9   MRS SCHOLTENS:          It does appear that way, yes.

10   PROFESSOR DUGGAN:            So that would be a weakness?

11   MRS SCHOLTENS:           That would be a systemic failure. You will recall
12   that in 1993 Dr Teague – certainly Dr Boyd in his evidence talks about the
13   establishment of a quality assurance process for dealing with histology and
14   cytology. Azimuth had asked, “what do you want to do with this so we can
15   design the computer system to deal with it”, and there was all that
16   discussion with Dr Teague, they worked out a quality assurance process but
17   of course it never became relevant until these reports started to come
18   through, which, as we know, was not until some time later.

19   PROFESSOR DUGGAN:              This is in response to Janet Phuah‟s paper, is
20   that the one?

21   MRS SCHOLTENS:           That's right, yes. And of course we haven't briefed
22   evidence about what was actually going on within the programme after
23   1996. I can't actually tell you what, if anything, was happening to these
24   reports in that period between 96 to 98.

25   PROFESSOR DUGGAN:               But you would accept now that the Peters
26   standards clearly detail how the calculations of all of these different
27   standards are carried out so that there is consistency?
     28/9/00                            C/ 937

 1   MRS SCHOLTENS:          Yes.

 2   PROFESSOR DUGGAN:              and that was lacking in the past?

 3   MRS SCHOLTENS:          Absolutely, yes.


 5   CHAIR: It seems to me at the moment that the type of evaluations that are
 6   contemplated in the Peters documents are themselves, if they are done by an
 7   independent monitoring group, going to run into problems if the legal
 8   position remains as it is?

 9   MRS SCHOLTENS:               Well, I understand that this, of course, was of
10   concern when it dawned on us could this be a problem, but I understand that
11   the monitoring group won't be looking at identifiable information, they
12   won't need to know who the particular individuals are, they will highlight
13   issues and then the programme itself will pick up those issues.            The
14   programme knows who the women are and the programme will deal with it.
15   That‟s my understanding.

16   CHAIR:      So the independent monitoring team would perhaps look at a
17   report much like exhibit 17 in the way that I was doing. You wonder why
18   you'd have them because in some ways you could just run it through a
19   computer and identify people with unusual smear histories and then give it
20   to the people working within the programme to go back and check on why
21   was that unusual pattern there and what is the point of the independent
22   monitoring group?

23   MRS SCHOLTENS:          I know very little about it. Do you want to take this
24   matter up with Mr Murray? I mean, I don't know what the independent
25   monitoring group are actually going to do.


27   PROFESSOR DUGGAN:              It‟s a concept in development, is it not?
     28/9/00                           C/ 938

 1   MR MURRAY:             Actually, the contract for the independent monitoring
 2   group has been let already to Dr Cox. His job now is to get his independent
 3   operating group working and I asked whether they needed the identifiable
 4   information and Dr Peters answer was no, not for the checking of the
 5   information that comes back and for the auditing of the providers they don't
 6   need it. But then if they need to go and look at clinical records they would
 7   need it.

 8   CHAIR:      Yes, if they wanted to check up with a laboratory because they
 9   thought that a woman‟s smear history looked a bit unusual, given a
10   diagnosis, they'd have to have her name to do that.

11   MR MURRAY:             Yes. The programme manager of course will have the
12   name.      They won't necessarily have to disclose it to the independent
13   monitoring group.       The independent monitoring group will produce the
14   information that will cause the programme to go out to a laboratory and say
15   “we need to follow up Mrs X because this looks like a problem.” That‟s as
16   I understand it now.

17   CHAIR:       It seems unduly complex in the sense that if you think of
18   companies where you have external auditors and internal auditors, the whole
19   point of having external auditors is you bring them in and they do an audit.
20   You don't have a situation where they go so far and then some work‟s
21   passed over. I mean, the more that a particular task from beginning to end is
22   with one group of people who are entirely responsible for it, the more likely
23   it is to get done, and certainly to get done in an expeditious manner. Once
24   you start cutting a task in half, or in quarters, you can run into problems.

25   MR MURRAY:             We are planning to bring that independent monitoring
26   group contract back to the inquiry – that‟s one of the items in the list, if you
27   like, that‟s being implemented now and we will just attach it to an affidavit
28   from Dr Peters. Rather than me speculating, I think perhaps she should say
     28/9/00                          C/ 939

 1   whether it‟s going to be working well or whether they‟ve got a problem with
 2   it.

 3   CHAIR:        Well, there's also the suggestion in order for the national
 4   evaluation to go ahead, and hopefully it won't be the one and only national
 5   evaluation, the decks need to be cleared with the information barriers there,
 6   don't they?


 8   MRS SCHOLTENS:           Can I just turn to another subject now, but it is still
 9   important in terms of the level of comfort or whatever that you can draw
10   from the programme, and that is the monitoring of the progress of the
11   programme against its goals and targets. I just wanted to really point you to
12   the most extensive evidence of this in case it sort of got lost in the pile
13   because it was Mr Lambie‟s extra exhibit that he produced on the Saturday
14   that he gave evidence.     This is exhibit 14.    That was a compilation of
15   extracts from the Ministry‟s publication “Progress on Health Outcome
16   Targets”, and the extracts all related to the cervical cancer from 1993
17   through to the 1990 draft. Now this got produced at a time when I was
18   sounding like Donald Duck, so very little was said about it.       Can I draw
19   your attention to a number of aspects of this.

20   1998, if we could turn to those targets, p27 on the top right hand corner.
21   1998 was the last published publication. The 1999 one was still draft. At
22   p29 you've got a pictorial figure of the incidence rate by ethnicity from 1980
23   to 95 and the targets that had been set for 2005, and that‟s the 3 year rolling
24   averages.

25   CHAIR: So if you look at it, it was down in 82, up in 86, then up again in
26   1990 and then starting to go down from 1990 onwards?

27   MRS SCHOLTENS:           Yes, that‟s right. The incidence for Maori of course
28   is, as you'll find notes right throughout these reports, you're dealing with
     28/9/00                             C/ 940

 1   such a small number that the variations are quite significant. So this paper
 2   discuses the progress that‟s been made towards the targets for Maori and all,
 3   and incidence and mortality. It also looks at a number of other indicators.
 4   It talks about data quality, you will see at the foot of p31, and the changes in
 5   recording for ethnicity at the top of p32, interpretation of trends.

 6   CHAIR:       There's something in the duRose study about rates of cancer or
 7   something.

 8   MRS SCHOLTENS:             Page 34, I just wanted to draw your attention to this,
 9   in terms of what might be expected internationally from a screening
10   programme. The sort of reference appears in most years as you go through
11   this document, but on p34 in the 1998 report, under the heading “Health
12   Impact”, third paragraph, there's a reference to Scandinavian countries
13   having considerable success, and then “reductions in mortality range from
14   10 to 80% depending on the level of cervical screening that had occurred in
15   the targeted population.” And I just wanted to note that and compare that,
16   before we look at New Zealand‟s figures, against the targets – just compare
17   that with the World Health Organisation guidelines which Dr Cox produced
18   because they have a reference, too, on what might be expected over certain
19   time periods. Now I'm not sure if that‟s – I think it‟s his exhibit 49, the
20   managerial guidelines.

21   CHAIR: The World Health one is –

22   MRS SCHOLTENS:             It‟s either 47 or 49.

23   CHAIR:       46.   This is World Health Organisation meeting “control of
24   cancer of cervix uteri”?

25   MRS SCHOLTENS:                  The managerial guidelines, “cervical cancer
26   screening programmes”?

27   CHAIR: Oh right, that‟s 47.
     28/9/00                           C/ 941

 1   MRS SCHOLTENS:           I thought it was 47. On p2 of those guidelines, the
 2   other pages aren't marked, on the left hand side under “Setting health
 3   objectives”, the second paragraph in terms of setting health objectives, it
 4   says: “In view of the fact that screening programmes in several countries
 5   have been able to reduce the incidence and mortality from cervical cancer
 6   by 60%, such a goal may be appropriate as a long term objective. This
 7   could be approached in stages, an initial objective being to achieve, for
 8   example, a 20% reduction in the incidence and mortality from the disease
 9   over a period of 10 to 15 years.” And obviously this is going to depend on
10   all sorts of factors within a country, but I thought it‟s useful to draw
11   attention to that in the World Health Organisation guidelines because
12   certainly against that sort of standard New Zealand, whatever‟s been
13   happening something‟s been happening well and we say that it‟s a result of
14   the increased coverage of the programme.

15   On p35, going back to Dr Lambie‟s exhibit 14 –


17   PROFESSOR DUGGAN:             Mrs Sholtens, the only comment I would make
18   is that the targets for the programme were set in – I'm just trying to find it in
19   my own book.

20   MRS SCHOLTENS:          They're at the front of each policy.

21   PROFESSOR DUGGAN:              Yes, but I have my own little quick reference.
22   There were targets set in the 1991 policy and there were targets set in the
23   1996 policy. The targets have not been updated since 96.

24   MRS SCHOLTENS:            I don't think so.   This progress towards outcome
25   targets does say when they‟ve been updated. I don't think they have since
26   then.
     28/9/00                                C/ 942

 1   PROFESSOR DUGGAN:                   Not since the 96 policy, they're absolutely the
 2   same?      What's in this document is what's in the 96 policy document as
 3   targets?

 4   MRS SCHOLTENS:               Right, yes.

 5   PROFESSOR DUGGAN:                   And it begs the question, when do you update
 6   your targets? Do you do it on a set schedule of every 5 years?

 7   MRS SCHOLTENS:                 Well, I can't answer that, just save to say they
 8   haven't got to where the dates are – you know, the target by 2000. Now I'm
 9   not sure whether there's a new target set in the –

10   PROFESSOR DUGGAN:                   Yes, but you see the problem is, as I see it, and
11   it‟s got to do with the Cancer Registry data, you only have data in the year
12   2000 going up to 1995 or something like that?

13   MRS SCHOLTENS:               Yes.

14   PROFESSOR DUGGAN:                   So it seems that they are 5 years behind so you
15   are already at your target year in 2000 but your data is 5 years behind you.
16   So you don't know if you've really reached your target?

17   MRS SCHOLTENS:               Well your information is getting more and more up-
18   to-date so that for the 1999 assessment you're looking at 97 and 98 data,
19   even if it is still draft.


21   CHAIR: And the evidence was there is actually reasonably good draft data
22   at a later time. It was just Dr Peters, in the HFA‟s report, they had used
23   final data and final data goes to 96 but cervical cancer data is apparently
24   very good and is available later in draft form. It just depends whether, as a
25   researcher, you want to rely on draft data or not.

26   MRS SCHOLTENS:                 That's right, and presumably with coverage and
27   enrolment in the programme getting so statistically high, and that being
     28/9/00                             C/ 943

 1   more up-to-date than the Cancer Registry, that sort of information will be
 2   more useful.

 3   CHAIR:       Yes, well, I suppose every time a woman is diagnosed with
 4   invasive cervical cancer that diagnosis would go on the Screening Register
 5   as well, wouldn't it, so the Screening Register should have both cases of
 6   cancer and high grade abnormalities?

 7   MRS SCHOLTENS:          It would certainly have incidence, yes.

 8   CHAIR: Do we know what are these targets, how were they set – in other
 9   words, were they over-generous or difficulties, easy targets, hard targets to
10   achieve?

11   MRS SCHOLTENS:          Well, we do know how they were set initially by the
12   expert group, updated by Skegg. I have recorded it in the submission, but
13   the 1991 review of the Skegg guidelines for cancer – sorry, that altered to
14   something different.   1995 by the Public Health Commission, I think was
15   the latest update.

16   CHAIR: I've just thought of something else. If the targets were set in 91,
17   as at 91 –

18   MRS SCHOLTENS:          For a 10 to 15 year period.

19   CHAIR: We didn't have a compulsory Cancer Register.

20   MRS SCHOLTENS:          No.

21   CHAIR:       Would the Ministry therefore have known before the Cancer
22   Register Act of all cases of cervical cancer in New Zealand?

23   MRS SCHOLTENS:           No, there would have been problems with the data
24   on the Cancer Registry, although I think the evidence has been that for
25   cervical cancer it wasn‟t so bad.

26   CHAIR:       Because unless you had really good reliable information about
27   cancer mortality and cancer incidence you've got to say when you're
     28/9/00                              C/ 944

 1   working out what should your target be to lower it, you need to know what
 2   you're lowering it from, don't you?

 3   MRS SCHOLTENS:            I understand what you're saying. I'm not sure where
 4   it takes us.

 5   CHAIR: Well, it‟s just I'm trying to work out – you see, this is being put
 6   forward to say the programme is successful because we've reduced cancer
 7   mortality.

 8   MRS SCHOLTENS:            Yes.

 9   CHAIR: And certainly it looks as if its gone down. What we don't know,
10   though, is really by how much, and the fact that it is attaining its targets
11   were they realistic targets

12   MRS SCHOLTENS:                  Well, I‟d say to you, in terms of assessing the
13   veracity of this information, the quality of the data is reviewed from 1993 in
14   each of these reports, so it tells you this information‟s come from the Cancer
15   Registry, it tells you about the quality of the data and it‟s all we've got. I
16   certainly understand the need to update goals, but nobody has suggested
17   that I'm aware of that the measures that were being applied were anything
18   other than appropriate, and the epidemiologists have essentially said, “Yes,
19   this programme is succeeding against its targets and its goals and they are
20   appropriate.”

21   CHAIR: Yes. Well if you look at the Cox exhibit 46, which is the World
22   Health Organisation publication of 86, and if you turn to p611 –

23   MRS SCHOLTENS:            This is “Control of cancer of the cervix uteri”?

24   CHAIR:          That's right.     When you get to p611 under the heading
25   “Impediments to screening”, the third paragraph down, which is middle of
26   the page, says: “Deficiencies in record keeping in cytology laboratories and
27   cancer registries make the administration, monitoring and evaluation of
28   activities very difficult if not impossible.” And then over the page, at 613,
     28/9/00                         C/ 945

 1   in the right hand column, second paragraph down it says: “Quality control
 2   systems must be developed in cytology laboratories to keep the number of
 3   false negative reports as low as possible.” And then over the page again at
 4   614, under the heading “Evaluation”, it says: “A cervical cancer control
 5   programme should not be initiated prior to the establishment of adequate
 6   evaluation procedures.    It is essential to assess progress of the screening
 7   programme periodically, both from the procedural standpoint to determine
 8   how effective the operations actually are, and in terms of achievement to
 9   analyse the extent to which morbidity and mortality have been reduced in
10   the population group covered.” And it says: “The following aspects should
11   be considered when evaluating the programme”, and then you can read
12   down and see what they are and (c) shows quality of control in cytology
13   laboratories as one of them.

14   MRS SCHOLTENS: And of course we know the first point – proportion of
15   unsatisfactory smears – was monitored.

16   CHAIR: Certainly, I accept it was monitoring of unsatisfactory smears in
17   terms of smeartaking which we have not looked at at this inquiry because
18   we've seen it as outside the terms of reference. Whenever I have said,
19   because I get tired from time to time, I will say there's no monitoring or
20   evaluation – I don't mean of the entire programme as such but of what we
21   are looking at about the programme, which is the reporting of laboratory
22   smears.

23   MRS SCHOLTENS:            I accept that and I think at times there's been a
24   misunderstanding of that, but when you are looking at trying to nail this
25   issue of the under-reporting similar to Dr Bottrill, I think as you've said,
26   unless we do this gold standard now, because we didn't have these very clear
27   processes in place with data for a lot of women, unless we do that evaluation
28   of really the whole programme now we‟re not going to know.
     28/9/00                            C/ 946

 1   CHAIR:       No. Well, you seed, at the top of 615 of this document it says
 2   that, because it says: “Screening programmes can be evaluated by their
 3   failures.”    And this is what they seem to be treating that as “cases of
 4   symptomatic invasive cancer of the cervix and especially of advanced
 5   disease can be regarded as failures of a screening programme.”          The idea
 6   being you pick it up earlier if the programme‟s really working.
 7   “Knowledge of the age, distribution of such cases and of their screening
 8   history provides information of the effectiveness of the programme in
 9   reaching the intended age groups and quality of screening being carried
10   out.” And then it looks at the registration, and further down it talks about
11   “an alternative to complete cancer registration as a mechanism of recording
12   all cases of cancer of the cervix this might be the responsibility of the
13   centres that follow-up and treat cases.”        But certainly it‟s talking about
14   identifying the cases where cancer has occurred and then checking them. I
15   don't know how many there are. I mean, Professor Skegg said that the
16   cancer incidence I think for Tairawhiti, in the second session when he came
17   back, is up to 60 I think he said. I don't know what timeframe he was
18   talking about there, but to get 60 cases and check back should be quite easy
19   – particularly if you used the Screening Register you could first of all know
20   straight away whether some of those cases were from women who were
21   unscreened, who had never been on the register, so you could check that out.
22   Then you would go back also and see what do their past histories look like?

23   MRS SCHOLTENS:              I realise it‟s outside the terms of reference, it just
24   occurred to me that if I was in the situation I went to the Dr I would say,
25   “What did my smear history show”. I don't know what the obligations are
26   on the GP in that situation.

27   CHAIR: I think the GP would have to provide you with the information.

28   MRS SCHOLTENS:           They might be surprised and say, “Oh, you've had
29   clear smears for so long”
     28/9/00                          C/ 947

 1   CHAIR:     Exactly, yes. A woman can get it off the Screening Register.
 2   Maybe we should recommend that, I've never done that and we should all do
 3   it.

 4   MRS SCHOLTENS:          That‟s right.


 6   PROFESSOR DUGGAN:            I know I'm not on the register!

 7   CHAIR: Sadly I don't know whether I am or not. I suppose I am.


 9   MRS SCHOLTENS:           I say that this performance progress against health
10   outcome targets is a way of evaluating the success of the programme.       W
11   e know the extent to which the data may/may not be good, but generally I
12   think we can say that it is reasonable evidence, if not very good evidence, of
13   both a reduction in incidence and mortality over this period – quite
14   drastically, and it also notes the increase in enrolments and the increase in
15   coverage. Coverage up to 85% now.

16   CHAIR: Yes, well, I accept what you say about enrolments and coverage.
17   One of the concerns I have about reduction and incidence and mortality is
18   that looked at overall from the state of the national it looks good, but when
19   you look at it, say, on a regional basis, for all we know there could be some
20   laboratories in some regions and other people associated with the screening
21   pathway doing an excellent job, which pulls the statistics up, and others are
22   not performing. So when you look at statistics they look great, but the fact
23   is they're often presenting an average and that average could be some areas
24   performing at a very high level and other areas performing at a low level
25   and overall the picture will look good but for the women in the low
26   performing areas it won't be good, and given we‟re talking about cervical
27   cancer it can be pretty bad for them.
     28/9/00                           C/ 948

 1   MRS SCHOLTENS:             Well, these are nationwide statistics. You've also
 2   seen the RHA did regional-wide statistics, and you know that beyond that
 3   the evidence was, “Well, you're dealing with such numbers that your
 4   statistics aren't particularly meaningful.”

 5   CHAIR:       Well, we do know from the duRose study that the incidence of
 6   abnormalities has gone up in the Tairawhiti region since 96/97, don't we?

 7   MRS SCHOLTENS:          I will accept that, yes.

 8   CHAIR:       What's really needed I suppose is regional information which
 9   shows you high grade abnormalities as well as cancer incidence so you can
10   see what they're looking like.

11   MRS SCHOLTENS:              Certainly, that‟s always been available on the
12   register. You've got your regional registers. All the information of what
13   high grades are going coming out of the region is there, and the programme
14   manager had the responsibility for keeping an eye on that.

15   CHAIR: So in a very rough way you could get, I don't know if the Cancer
16   Register shows you incidence and mortality on a regional basis, I know I
17   saw some early figures for mortality.

18   MRS SCHOLTENS:              They can provide that information but it‟s not
19   assimilated in that way.

20   CHAIR:       Because if you got that and compared that to the Screening
21   Register information for high grade abnormalities being detected, if there
22   was too great a disparity there that might cause some concern.

23   MRS SCHOLTENS:          Yes.


25   PROFESSOR DUGGAN:              I think an important point to consider is that the
26   incidence of cervical cancer may have dropped for reasons other than
27   screening.
     28/9/00                           C/ 949

 1   MRS SCHOLTENS:           Yes.

 2   PROFESSOR DUGGAN:               It may be that, I don't know – I mean, I could
 3   think of some extraordinary hypothetical reasons as to why it would
 4   disappear from New Zealand. Just as an exaggeration all the women likely
 5   develop cervical cancer and all decided to emigrate to Australia and
 6   Australia‟s rates will go up and New Zealand will go down.

 7   MRS SCHOLTENS:           Mmm.

 8   PROFESSOR DUGGAN:                But unless you analyse your failures, unless
 9   you analyse how the women who develop cancer participated in the
10   screening programme, you really are not clear about how effective your
11   programme actually is.

12   MRS SCHOLTENS:           I accept that.


14   CHAIR:    Well, we've gone now past the afternoon break, so we will stop
15   now and come back at 5 to 4.



18          MID-AFTERNOON ADJOURNMENT 3.40 TO 3.55 P.M.

     28/9/00                            C/ 950

 1                    THE HEARING RESUMED AT 3.55 P.M.

 2   CHAIR: Mrs Sholtens, I think Ms Anderson has something.

 3   MS ANDERSON: I have a letter, a reply from the Minister, ma'am, to Mr
 4   Corkill which I wish to table. I don't wish to be heard on it though.

 5   CHAIR: No, just circulate it

 6   [Tape turnover]

 7   CHAIR:        … from having heard Professor Evans.         That flows from the
 8   advice that they have that the Privacy Act applies and that the information is
 9   not readily obtainable.    I would have thought that if they were aware that
10   the information could be obtained under the Official Information Act, and
11   that any New Zealander who could make a case under s91 to obtain the
12   information could do so, that might well affect their approach to questions
13   of consent.

14   MRS SCHOLTENS:            Yes, and the matter as you'll see, it‟s proposed that it
15   all goes back, a new protocol goes back to an Ethics Committee and this
16   time all those sorts of issues, we hope, will be able to be worked through.

17   CHAIR: Yes, well although the letter says that the audit can go ahead, it‟s
18   still dependent on various things happening, isn't it?

19   MRS SCHOLTENS:             Yes, well, it looks to me, and I must say because
20   there's been so many different suggestions of ways through, I‟m getting my
21   head around the agreed way through at the moment, but it looks to me like
22   from this penultimate paragraph on p2 that the modified protocol‟s going to
23   go back to an Ethics Committee on the basis of proceeding on informed
24   consent as far as possible and in the meantime there will be legislative,
25   inter-regulatory amendments which, if there's a need to go beyond informed
26   consent, public debate will have been had and changes to the law will be in
27   place or whatever. But it does appear that it can go ahead on the basis of a
28   revised protocol, ethical approval, informed consent.
     28/9/00                             C/ 951

 1   CHAIR:      But it isn't actually going ahead at the moment because it still
 2   requires approval doesn't it?

 3   MRS SCHOLTENS:           Well, my understanding is there either is or being a
 4   revised protocol with this slide re-read in it, and I understand it is going to
 5   the   Health    and    Disability    Services    Commissioner     and     Privacy
 6   Commissioner in an attempt to ensure there's support before it gets put
 7   before an Ethics Committee again. And I think all the issues will have been
 8   well and truly debated and presumably that Ethics Committee process will
 9   be very carefully monitored.

10   CHAIR: Thank you.


12   MR HINDLE:         Ma'am, just while we‟re on this letter, could I just say,
13   having actually attended that meeting, the report I gave you of the reasons
14   why the University of Otago had some problems with proceeding, here the
15   Minister has recorded in particular issues relating to the right to public
16   findings.   This doesn't bear on anything, but I think in fairness to the
17   researchers they did actually have some more substantive reasons than that
18   which aren't recorded in this letter.         It doesn't make any difference to
19   anything, but I wouldn't want the letter to be taken as evidence of anything
20   other than what the Minister intends to do with the legislation really.

21   CHAIR: Well, that‟s helpful because I've written a ruling which is about to
22   go out and I now probably am going to have to hold on to it. I don't know
23   for sure, because I'm no sure whether the factual narrative of the ruling is
24   accurate now. If I had got it out before I accepted the letter it would have
25   been all right but now I'm going to have to go back over it, so I think to be
26   safe I‟d better not issue the ruling today.

27   MR HINDLE:        What I said in my report about why the researchers had
28   some reservations about the Ministry doing the study, if you like, because
     28/9/00                            C/ 952

 1   that way the information wouldn't have to be released. The minister in this
 2   letter has said, “Well, there were issues about who would get the results
 3   published and whether it would be the University or the Ministry of Health,”
 4   and to be blunt about it, that's a bit of a trifling concern.        What the
 5   researchers said and what's reported in the document I gave you on Monday,
 6   which Professor Skegg had approved, is that the researchers said “it is
 7   important to be involved in the initial contact stage” because that gives them
 8   their opportunity to talk to the general practitioners and the health care
 9   providers and answer questions. I mean, the GP may say, “All right, but
10   how long is this going to take – do you want to interview my patient.”
11   They see that as important.        I just wanted to simply suggest that the
12   researchers don't want to go ahead because they won't be able to public the
13   results. It‟s a bit tough on the researchers.

14   CHAIR: Just help me here because just off the top of my head in the ruling
15   I had made the comment that the evaluation hadn't gone ahead to date and
16   there was no indication whether it was going, how it would go ahead.
17   Would that still be accurate or not?

18   MR HINDLE:            It would still be accurate.   My understanding of the
19   position is that the evaluation protocol has been withdrawn, or rather the
20   Ethics Committee has now been asked not to determine it because it has to
21   be amended to include the slide review protocol. The slide review protocol
22   hasn‟t been developed and I think in part that‟s because Dr Cox is on
23   holiday this week which is probably a well deserved holiday.

24   CHAIR:      That‟s different, though.     That‟s just a variation.   What I'm
25   trying to find is –

26   MR HINDLE: No, ma'am, because what it comes back to is this. When it
27   finally goes back to the Ethics Committee it will be supported by the
28   opinion, hopefully, of the Privacy Commissioner and the Health and
29   Disability Commissioner in favour of it, but the Ethics Committee is going
     28/9/00                              C/ 953

 1   to have the same decision to make, and whilst we all hope that the Ethics
 2   Committee will give it a different consideration in its revised form, we don't
 3   know that that‟s going to happen.

 4   CHAIR: No.

 5   MR HINDLE:        We are still in the hands of the Ethics Committee on that.

 6   CHAIR: So to say then that at the moment the national evaluation has not
 7   proceeded is still accurate?

 8   MR HINDLE:        That is correct.

 9   CHAIR:     That‟s all right, it‟s just purely personal, I‟m getting tired of re-
10   writing this ruling.

11   MR HINDLE:        No, that is a correct statement of fact.


13   MR MURRAY:             We‟re more concerned with the end of the ruling?

14   CHAIR:      Well, my mind varies according to what I hear. It‟s just about
15   ready to come out but I have to play around with it again. I‟ll keep you
16   waiting until tomorrow.


18   MRS SCHOLTENS:               Can I say, ma'am, that we would have very much
19   liked to have been able to explain to you in clear terms how the evaluation
20   would proceed.         Until I've read this, I've not been satisfied that they‟ve
21   actually sorted out everything.

22   CHAIR:      That‟s fine.      As long as you say that, too, that just keeps me
23   happy from the perspective of the narrative in my ruling.

24   MRS SCHOLTENS:              Yes, and I think you should register there is a real
25   determination to let it proceed, and if Ethics Committee guidelines need
26   revising – short of overriding critical principles and perhaps deterring
     28/9/00                           C/ 954

 1   women from registering, I think, the Ministry and the Minister, as I
 2   understand it, are very concerned to have this evaluation proceed.
 3   They do understand.

 4   CHAIR:      Well, it seems that, as I've said before, it‟s one thing to say
 5   women may be deterred from registering on the register because they don't
 6   want their information released, but if it‟s not going to be effectively
 7   monitored and evaluated in terms of the quality of smear reporting, which is
 8   when I referred you to the World Health document earlier you will see is, in
 9   a sense, one of the lynchpins of a programme making sure the smear
10   reporting is accurate. I think women need to be told that and women may
11   then decide they don't want to register because they see no point in
12   belonging to a programme that is not being effectively monitored and
13   evaluated. I mean, that is the other side of the coin, really.

14   MRS SCHOLTENS:            That‟s right, yes, it is. And those are the policy
15   considerations to be debated and weighed.

16   CHAIR: I think what you don't want is a situation where women think it‟s
17   happening but it isn't so they stay on the programme.

18   MRS SCHOLTENS:          Indeed.

19   CHAIR: Because that is not being open with them.

20   MRS SCHOLTENS:            No, that's right.   Ma'am, can I then come back to
21   what we say is one form of monitoring and evaluation of the programme at
22   the higher level?

23   CHAIR:     Yes, well I‟d like to hear about all the examples of monitoring
24   and evaluation that you say have actually happened so that I can look at
25   them for the purpose of writing the report.

26   MRS SCHOLTENS:             It‟s a tall order.    This progress against health
27   outcome targets, the point that was made just before the adjournment about
28   possibly the data being incomplete, can I just make the point that the cancer
     28/9/00                            C/ 955

 1   mortality data, I think the evidence is, has always been relatively complete
 2   in fact because it‟s easy to access. In terms of incident data, well if that was
 3   a problem before 1993, then obviously that means the improvements since
 4   that time anyway has been more dramatic, not less.         So certainly it‟s my
 5   understanding that the data is basically parallel anyway and so there doesn't
 6   seem to be a problem with data quality. I think the reports do discuss that.


 8   PROFESSOR DUGGAN:                 Mrs Sholtens, Professor Skegg submitted a
 9   report – I don't know where my copy is but I think you know the report I'm
10   talking about, it‟s about the four region study?

11   MRS SCHOLTENS:           Yes.

12   PROFESSOR DUGGAN:               and the information that he got from the Cancer
13   Registry. He expressed concern about the accuracy of the information,
14   raising the possibility that some of the registrations actually related to
15   women with high grade disease as opposed to women with invasive cancer.

16   MRS SCHOLTENS:           Yes, and I remember, and I think the document deals
17   with it – I'm afraid I can't tell you exactly where, but I remember that arising
18   as an issue that reporting of incidence of cancer to the register as I recall it –
19   was it CIN II or III and above?

20   PROFESSOR DUGGAN:               Yes.

21   MRS SCHOLTENS:           And the smears themselves may not have been right.


23   CHAIR:       And also I suppose of the Cancer Register had high grade
24   abnormalities on it as cancer, if later it cleaned its data up and removed them
25   they would look like quite a fall in cancer rates because you'd be removing
26   the abnormalities?
     28/9/00                           C/ 956

 1   MRS SCHOLTENS:           If they were taken off. I don't recall any evidence
 2   that says that was happening.

 3   CHAIR: No, I was just speculating.

 4   MRS SCHOLTENS:           As I understand it the rule is you report CIN III to
 5   the Cancer Registry as incidence.

 6   CHAIR: So that‟s in their Act or it‟s in their regulations or it‟s somewhere?

 7   MRS SCHOLTENS:          Sorry I can't tell you where, but yes.


 9   PROFESSOR DUGGAN:                 I would accept that that‟s an international
10   standard in terms of cancer registration, you register high grade – actually
11   CIN III and invasive cancers, but Professor Skegg‟s concern is that in terms
12   of the registrations, the numbers of registrations he got from the Cancer
13   Registry, he was surprised that there were so many and believed that the
14   data set included CIN III as well as invasive cancer.        Now when I see
15   comments like that I start to worry about all of the data that‟s coming out of
16   the Cancer Registry and all of the reports that I have seen that relate to
17   incidence data and mortality data, any report that relates to data coming out
18   of the Cancer Registry, and I think you know by now that my biggest
19   concern is that aspect. And I think even this document DGL/0014 actually
20   states data quality in terms of assessment. They stipulate many times that
21   there are concerns about the data quality.

22   MRS SCHOLTENS:          Yes, and that it hasn‟t been assessed.

23   PROFESSOR DUGGAN:               You know, again, it may be misleading and in
24   fact this issue about high grades being counted with the invasive cancers can
25   be misleading in the opposite sense – i.e. your programme might possibly be
26   even more successful if you take all the CIN III‟s out of the registrations.

27   MRS SCHOLTENS:          Yes.
     28/9/00                             C/ 957

 1   PROFESSOR DUGGAN: Do you see my point?

 2   MRS SCHOLTENS:            I see your point. There's no response I can make.

 3   PROFESSOR DUGGAN:               No. I suppose the response you could make is
 4   that data integrity is critical to the monitoring and evaluation of the
 5   programme.

 6   MRS SCHOLTENS:            Absolutely, yes. Well, I agree with that, yes.


 8   CHAIR:        Which is why really it leaves things up in the air because until
 9   you can be confident of the data integrity you then have got to say, “Well,
10   that‟s the tools you work with in order to be able to evaluate or make some
11   analysis of what is happening.” So that‟s why I get back to that point that
12   the foundation is shaky at the moment – or that‟s what it appears to be.

13   MRS SCHOLTENS:            Right. Well I suppose, I mean, we know the facts
14   are this data is of this level of assumed quality, there hasn‟t been an
15   evaluation of the data quality on the Cancer Registry, we know there's just
16   recently been one of what's on the Screening Register, and we hear that it‟s
17   fine. Dr Cox has got a lot of contractual obligations to fulfil and he hasn‟t
18   written up that part of this.


20   PROFESSOR DUGGAN:                Actually, that‟s a very interesting point. Has
21   there been an audit of the data integrity on the Cancer Registry?

22   MRS SCHOLTENS:             As I understand it that‟s part one of the national
23   evaluation.

24   PROFESSOR DUGGAN:               That‟s the cytology registry I thought.

25   MRS SCHOLTENS:             Sorry, yes. You asked about the Cancer Registry.
26   No, I believe the report notes that no, there has not been an evaluation of the
27   Cancer Registry data.
     28/9/00                             C/ 958

 1   CHAIR: Do you want to check with Dr Lambie or do you know for sure?

 2   MRS SCHOLTENS:           I've certainly read it in here. We‟ll check. Just one
 3   more point in this BGL/0014, p35, the limitations of the indicator, I just
 4   wanted to draw attention to this on another subject which Dr Duggan has
 5   asked questions about.         “Limitations of indicator”, it notes that women
 6   being screened by the programme are unlikely to correspond to all women
 7   being screened in the population as a small % of women will be having
 8   regular smears but have chosen not to be enrolled in the programme.          I
 9   know you've asked us, and I think we've given different answers at different
10   times, about who‟s on the programme. There's not a clear answer, but I
11   think one of your concerns was whether laboratories could read smears for
12   people who weren‟t on the programme but not meet the standards.          Now
13   that issue, I think, is not a possibility because the programme now looks
14   after all cytology services.

15   CHAIR: And also I read, it might have been in Stratton actually, one of the
16   early documents we were looking at today I happened just to light on a page
17   where there was a discussion on whether or not there should in fact be
18   separate laboratory funding for women on the register.        The reason was
19   something to do with – it wasn‟t that they were going to pay laboratories
20   differently, the money was going to come out of a different budget, it was
21   all to do with Area Health Board‟s, it was way back in that time, and I forget
22   the names of the various bodies, but it was suggested one body would pay
23   for the register, women in another body would be budgeting for – there was
24   a sort of general medical fund which would pay for the non-register women,
25   and they decided, “No, that‟s not going to work, we will just fund all
26   cytology in the same from the same budget.”          So it seems, in terms of
27   laboratories and laboratory funding, smear reading is treated the same
28   whether you're on the register or not.
     28/9/00                          C/ 959

 1   MRS SCHOLTENS:          Yes, that's right, and you could see the difficulties at
 2   that time when people were being added on to the register in large numbers
 3   how difficult it would have been to distinguish for payment purposes.

 4   CHAIR: Yes, and I don't think there's ever been any suggestion we should
 5   have a two-tier system where women off the register in some way get a
 6   substandard service in laboratories.

 7   MRS SCHOLTENS:          No, that‟s right. I suppose the only reason why it‟s
 8   significant to identify those women who‟re on the programme as those
 9   women who have chosen to be enrolled and on the register is that the
10   register data is the important information which enables quality assurance to
11   take place. It does provide the women with that added service. They get
12   re-read follow-up.    The smeartakers get reports.       If they're not on the
13   register their smeartakers don't get quality of smear reports relating to a
14   large number of women.

15   CHAIR:      As I saw it you could see the programme as being a large
16   umbrella with various facets, and the main core function really is the register
17   and those who are attached to the register to get a lot of benefits. Women
18   who are not on the register are going to get some spin-off benefits in the
19   sense that now that there are the Peters standards for laboratories women
20   who aren't on the register their smears will still be read by laboratories
21   subject to those standards.

22   MRS SCHOLTENS:          Yes.

23   CHAIR: and if there is monitoring and evaluation of quality of smeartaking
24   of laboratory performance, then that is going to have a spin-off benefit for
25   the women not on the register because if something‟s found to be not
26   working, then obviously the message is going to go back to the provider and
27   the provider is either going to have to shape up or stop doing the work.
     28/9/00                           C/ 960

 1   MRS SCHOLTENS:            I think it is very clear that as we've seen from the
 2   opt-on period, limited statistical information doesn't enable you to monitor
 3   appropriately.

 4   CHAIR:      That's right, and that‟s the real concern, you see, about the
 5   requirement at the moment to get informed consent, because if you have to
 6   get informed consent the chances are you're not going to get informed
 7   consent if you have to go out to women and ask for it from a sufficient
 8   number of women to be able to make the exercise worthwhile. Or if you do,
 9   you are going to take a long time in doing it.

10   MRS SCHOLTENS:           Yes. Now I won't take you through the data, given
11   your obvious concerns about it.      The 1999 draft report does demonstrate
12   that subject to all the caveats that you've pointed out, the targets set for 2005
13   have been reached, 40% overall mortality decrease in the time of the
14   programme, 35% in incidence for Maori and 25% overall.               The gap‟s
15   closing, according to these figures, enrolment from the register 91% and
16   coverage I think is in Ms Glackin‟s, the end of her affidavit, and is about
17   85%.

18   CHAIR: If you look at p40 where it shows the incidence rates starting to
19   drop in 1990, it‟s hard to imagine that the incidence of cervical cancer
20   would have started to drop at an early stage. I think what Mr Murray says
21   is that the programme didn't really come into being until 91.

22   MRS SCHOLTENS:           The evidence is, though, Madam Chair, that, yes, the
23   last register came on line – whatever you call it – in February 1992, and
24   people talk about the programme being established in 1990/91.

25   CHAIR: Yes.

26   MRS SCHOLTENS:           But we know that there was a significant increase in
27   people showing up to their Dr for screening around the time of the
28   Cartwright Inquiry in 1988.
     28/9/00                              C/ 961

 1   CHAIR:       I'm just trying to think why the incidence would have started
 2   dropping about 1990., I suppose even then, given the development of the
 3   disease, I suppose what it shows is in the 80s women were starting to have
 4   smears more.

 5   MRS SCHOLTENS:              The report itself shows the recent lower incidence
 6   rates are most likely due to improvements in cervical screening since the
 7   mid-1980s.

 8   CHAIR: Yes, I think that would be right.


10   PROFESSOR DUGGAN:                 I think some of this may be attributed to 1990
11   to 1993 you had the opt-on period.

12   MRS SCHOLTENS:             Yes.

13   PROFESSOR DUGGAN:                 Now if you look at Dr Bottrill‟s smears/annum
14   it seems to be 5,000 smears every year. It‟s very consistent. It didn't change
15   between the opt-on or the opt-off period, it seemed to me anyway, so
16   women were being screened. A lot of women were being screened in that
17   period 1990 – 1993 but they weren‟t enrolled in the programme?

18   MRS SCHOLTENS:             Yes.

19   PROFESSOR DUGGAN:                 Or they weren‟t on the register – they were not
20   on the register?

21   MRS SCHOLTENS:             Yes to both.

22   PROFESSOR DUGGAN:                 So there may very well have been high levels of
23   PAP smear screening in 1990 post-Cartwright which would have increased
24   the knowledge with regard to the benefit of screening?

25   MRS SCHOLTENS:             Yes, that‟s possibly right. I haven't gone back over
26   it but that seems right.
     28/9/00                           C/ 962

 1   PROFESSOR DUGGAN:              and you have coincidence here, you have a drop
 2   in the incidence, lots of possibilities for screening to increase, and there's
 3   some logic to saying, “Well, yes, screening caused a drop in incidence.”

 4   MRS SCHOLTENS:          Yes.

 5   PROFESSOR DUGGAN:              One has to consider there may be other reasons
 6   as well?

 7   MRS SCHOLTENS:           Yes.     Well, I do go back to, you know, Professor
 8   Skegg and I think the evidence of the experts generally, that coverage is the
 9   key, the thing that most impacts on incidence and mortality if women are
10   being screened and coming back within a regular period.          And in New
11   Zealand we now have 85% over the 5 year period. It is good coverage.


13   CHAIR:      Well, if you look, for example, at p13 which shows you the
14   proportion of invasive cancer detected at stage 2 or 3 you can see that it‟s
15   going down all the time. So if you look at it, the drop starts at about 1984.

16   MRS SCHOLTENS:          Yes.

17   CHAIR: Professor Duggan assures me this means that they're picking it up
18   sooner, I checked that out with her in case I wasn‟t reading the graph
19   properly.

20   MRS SCHOLTENS:          Right, thank you.


22   PROFESSOR DUGGAN:                However, that may also be attributable to
23   enhance colposcopy services.

24   MRS SCHOLTENS:          Yes, well, I do not know.

     28/9/00                               C/ 963

 1   CHAIR:      The reason I just mention that is because it shows a drop way
 2   back from 84. What it shows I think is the benefit in the 80s of women
 3   being encouraged to have more smear tests.

 4   MRS SCHOLTENS:           Yes.


 6   PROFESSOR DUGGAN:                Actually what our dialogue indicates to me is
 7   that the graphs are very interesting, they pose a lot of questions.

 8   MRS SCHOLTENS:           Yes.

 9   PROFESSOR DUGGAN:                Several hypotheses are built around there and
10   those hypotheses have to be investigated.

11   MRS SCHOLTENS:           Yes.

12   PROFESSOR DUGGAN:                And you already told me that looking at why
13   the programme failed is one way of investigating.

14   MRS SCHOLTENS:           That's right.

15   PROFESSOR DUGGAN:                    And if you're picking up the disease at an
16   earlier stage you should ask the question “Well, why?”.               It may not
17   necessarily relate to screening.

18   MRS SCHOLTENS:           Indeed.

19   PROFESSOR DUGGAN:                    It may relate to enhanced gynaecological
20   services that the gynaecologists are now recognising invasive cervical
21   cancer at an earlier stage.

22   MRS SCHOLTENS:           Yes.

23   PROFESSOR DUGGAN:               Or women are presenting for examination.

24   MRS SCHOLTENS:                Yes.      All that is accepted.   I guess I accept
25   everything you say, no doubt about it. From the Ministry‟s perspective I
26   suppose it‟s a bit hard to just – what I'm trying to say here is that the World
     28/9/00                           C/ 964

 1   Health Organisation guidelines say you've got to set goals. We set goals.
 2   We set goals that seemed realistic and were based on expert advice and
 3   seemed to measure up well to the World Health Organisation guidelines.
 4   We tried to improve our data, and they say this is the way you monitor and
 5   evaluate your programme at this top level.      We have done that.     That‟s
 6   what I‟d like to say, we have done that and attempted to do it very well.

 7   CHAIR: Well you might have attempted. I have difficulties here because
 8   when I look at the World Health Organisation guidelines, or the European
 9   guidelines, you set yourself targets for reducing the incidence of cancer and
10   cancer mortality , and okay, you're meeting those.

11   MRS SCHOLTENS:         Yes.

12   CHAIR: But there's a whole range of other stuff that you should be looking
13   at.

14   MRS SCHOLTENS:           Absolutely. When you drill down to the different
15   parts of the screening pathway.

16   CHAIR: Exactly, yes, and when you get to that level. Those passages on
17   the World Health Organisation document that I just took you to, which spell
18   out the need at the very day one of the programme for ensuring that you've
19   got good data collection, good monitoring and evaluation of laboratory
20   performance, that's what's missing.

21   MRS SCHOLTENS:          Well, that certainly is what's missing. That did not
22   happen.

23   CHAIR: I don't dispute that and other aspects of the programme. A lot of
24   good things may have happened. I mean, part of the difficulty I think the
25   Ministry has faced is that our terms of reference have been very
26   circumscribed in some ways, because although in some ways they are
27   widely drafted, they are focused purely on under-reporting and if you're
28   going to look at mis-reporting, and particularly in the guise of under-
     28/9/00                          C/ 965

 1   reporting, that in a sense could be said to be an Achilles heel in the
 2   programme and it means that everything we look at, and a lot of evidence,
 3   and a lot of the comments do come out as negative. If, for example, we had
 4   had the task – not that I would invite it – of looking at the entire programme,
 5   then of course there would have been a lot of evidence come in about
 6   enrolments, a lot of evidence about the type of monitoring and evaluation
 7   that took place in terms of enrolments, smeartaking, etc., and so that type of
 8   information would be out there as well as the sort of information we have
 9   been focusing on so that a more balanced picture of the overall performance
10   of the programme would be out in the public domain. It‟s just that because
11   of the limited focus of the inquiry, and it stands to reason because you don't
12   normally have public inquiries to look at services that are functioning well,
13   it‟s only when something‟s gone wrong and then you tend to have the focus
14   on what you think has gone wrong and that's why things have come out the
15   way they have.

16   MRS SCHOLTENS:          Yes. The simple point is that the outcomes are some
17   evidence, acknowledged by the World Health Organisation that this is a
18   successful screening programme, or, at the very least, that the screening
19   services are working.

20   CHAIR: Yes.

21   MRS SCHOLTENS:            And that includes smear reading and reporting
22   services.

23   CHAIR: Yes.

24   [inaudible]

25   MRS SCHOLTENS:           Yes, well, we are focusing on the things that need
26   improving. There is obviously a concern that women‟s perception will be
27   that they ought not to register on the programme, or that if offers them
28   nothing, and we‟d be very concerned about that.
     28/9/00                          C/ 966

 1   CHAIR: Yes, I accept all of that, and I can see it is a pressing concern and
 2   it‟s something to bear in mind in the writing of the report. It is something,
 3   too, for the Ministry to get across in its education material, its publicity
 4   material, because in a sense our duty is to report on the terms of reference,
 5   to report to the Minister, to give her material that is actually going to help
 6   her deal with the problems. We‟re not here as a media exercise, so in that
 7   sense we do have to be mindful, but my concern is to ensure that the best
 8   evidence and the best comment on the evidence and conclusions drawn from
 9   that evidence go to the Minister so that she can get answers to the terms of
10   reference. And it‟s a matter of doing that task, and certainly we don't want
11   to undermine the confidence of women in the programme, but we don't see
12   our role as being to make women feel confident about the programme in its
13   current form.

14   MRS SCHOLTENS:         Yes.

15   CHAIR:     We hope, if our recommendations are accepted, they can feel
16   confident, but that depends on our doing a good job and our
17   recommendations being accepted.

18   MRS SCHOLTENS:          Indeed. We are all here with one common interest,
19   and that‟s to ensure that we have a good programme and that the health and
20   safety of women in New Zealand is protected. I want to make an addition
21   evidence reference to one of the paragraphs in the submission. Page 48,
22   paragraph 153 – the subject that begins on p47, talking in 152 about the
23   information that Dr Teague had in 1995 about the Gisborne laboratory and
24   the status of TELARC accreditation.       So, the fact that he knew that Dr
25   Bottrill‟s laboratory wasn‟t TELARC accredited, and the fact that he didn't
26   see that as a piece of information to pass back to the programme. There's
27   just one more evidence reference to add on to 153 and that is the note of a
28   CSAC Minute in 1996 which can be found in Cox, Volume 1, Exhibit 5,
29   p132a,. at in particular 132b, where it says that:      “Clint reported that
     28/9/00                              C/ 967

 1   laboratories not registered with TELARC and not performing adequately
 2   according to TELARC standards will have their funding cut by the HFA.”
 3   And there's also a note about all laboratories must have quality assurance.
 4   It‟s just, in terms of the chronology, to note that still in February 1996
 5   CSAC – that‟s not the technical advisory group, this is the Ministerial expert
 6   group – was still hearing that there might be laboratories which weren‟t
 7   TELARC registered.

 8   CHAIR: Well, if you look at your paragraph 150 as it appears at the top of
 9   p47 where you have Dr Teague saying, I think it‟s dated as at July 1995, that
10   he was astounded to find there was a laboratory that wasn‟t registered. That
11   pre-dates the CSAC minute of the meeting in 1996 when he‟s supposed to
12   have said that there were still laboratories that weren‟t accredited.

13   MRS SCHOLTENS:           Yes.

14   CHAIR:     So it is still possible that he was astounded in July 95, and then
15   subsequently in February 96 got further evidence to show there were
16   laboratories still not accredited.

17   MRS SCHOLTENS:            Right. The point is that it wasn‟t ever raised as an
18   issue that should cause some concern to the programme.

19   CHAIR:       But you see this is the point.      It‟s always, you know, this
20   dependence on advisory groups.            At what point, given that this is
21   government money paying for this programme, does someone in the
22   Ministry say, you know: “Things aren't going the way we thought they were
23   going. We have these funding contracts with the RHA‟s saying reasonable
24   endeavours to have TELARC accreditation. We expect it to be happening,
25   it‟s February 1996, it‟s still not happening.” Is it really good enough for the
26   Ministry just to sit there waiting for outside people who are – if they're not
27   volunteers, it‟s not as if they're actually salaried people getting paid a lot,
28   they are busy people in their own occupations, and they're supposed to sort
     28/9/00                             C/ 968

 1   of come forward and check on the Ministry and tap them on the shoulder
 2   and say, “Look, things aren't happening.”         I would have thought that at
 3   some point the Ministry has an obligation to say, “We've run the programme
 4   this way, but where is it getting us?        We‟re not moving along very fast,
 5   we‟d better start doing something.”

 6   MRS SCHOLTENS:               Yes, I agree.     I think we need to have a look
 7   carefully at the role of what advisory groups was because they do have
 8   legislative backing and they were very much the way things were done at
 9   the time. I want to take you to that evidence, but the other thing is just to
10   note that each time the issue of TELARC accreditation appears in any of the
11   papers with the Ministry it‟s not an issue.       It‟s not raised by any of the
12   expert people as a concern.

13   CHAIR:      But this is probably where the Ministry lacked its own in-house
14   expertise because if the Ministry had –

15   MRS SCHOLTENS:             Well, possibly.

16   CHAIR:      - you know, sound medical people working within it, they may
17   have said –

18   MRS SCHOLTENS:             Maybe, but we are speculating. I mean, TELARC
19   accreditation wasn‟t rocket science, it was just that‟s the quality assurance
20   process that the programme had on expert advice decided to adopt. There
21   was a lead-in programme and it got extended out.

22   CHAIR:        Well, this is the point.   The lead-out period got extended out.
23   The whole idea was to have it as at 91. There you are in February 96 and
24   you still don't have it.

25   MRS SCHOLTENS:              But we don't know why, although I will take you
26   through the different evidence about why that might have happened.         All
27   we know is it did happen.
     28/9/00                           C/ 969

 1   CHAIR: Put it this way: If between the year 91 to 96 I didn't pay tax and
 2   then I turned around and said, “Well, my accountant wasn‟t telling me. He
 3   was my adviser.” I mean, so what?

 4   MRS SCHOLTENS:          Well, you would be under a legal obligation.

 5   CHAIR: Well, I might, but putting aside the law, I mean, really you can't
 6   just say, “I‟m relying on X over there to do things for me and if they're not
 7   getting done well it‟s X‟s fault for not telling me.”

 8   MRS SCHOLTENS:           I understand what you're saying, I'm asking you to
 9   consider what actually happened in the context in which it happened, and
10   that is a complex context with many situational factors, and certainly you
11   can come to the view at the end of the day that somebody should have done
12   something differently. In fact you might come to that view at a number of
13   different points, but I look at this as a who, what, why exercise. You've got
14   the WHO guidelines that tell you how to do it. You've got what did in fact
15   happen, and that is a complicated thing to figure out – I've certainly found,
16   anyway, and then why – why did it go the way it went? Why did it happen
17   that way?     And that's very complex as well.          And there are a lot of
18   “situational factors”, which is a lovely phrase that I picked out of James
19   Reason‟s article, that come to bear.     It doesn't mean to say you can't say,
20   “Well, this is very unfortunate and here is what should have happened.”


22   PROFESSOR DUGGAN:              But Mrs Sholtens, Professor McGoogan told us,
23   and I think Professor Skegg also told us, that the programme would falter if
24   the laboratories did not have quality control. They told us it was the weak
25   link.

26   MRS SCHOLTENS:          Yes.
     28/9/00                             C/ 970

 1   PROFESSOR DUGGAN:                and at the time the programme was introduced
 2   there was a brouhaha in the US with relation to the quality of laboratory
 3   services in cytology?

 4   MRS SCHOLTENS:            Yes.

 5   PROFESSOR DUGGAN:                So there was a lot of information right at the
 6   time that this programme was being established?

 7   MRS SCHOLTENS:            Yes.

 8   PROFESSOR DUGGAN:                That drew attention to the importance of the
 9   laboratories.

10   MRS SCHOLTENS:            Hmm. People thought that they had that covered in
11   1990/1991. We can see that from the documents: they thought that quality
12   assurance (inaudible)

13   PROFESSOR DUGGAN:                 Yes, because in 2 years it was going to be
14   implemented?

15   MRS SCHOLTENS:            Yes, they thought they had dealt with it.


17   CHAIR:          One of the things you could say is, if you accept Dr Boyd‟s
18   model, if there‟d been an Chief Executive and if that person had been a
19   public health officer that person could have listened to what the various
20   advisory groups were saying, seen as at 91, they thought accreditation of
21   laboratories was a way of ensuring quality control and that person would
22   have understood that laboratories were the weak link and when it didn't
23   seem to be happening they would have, one hopes, started asking questions
24   about why wasn‟t it happening, going to senior people within the Ministry to
25   say, “We need this to happen, how can you make it happen?”.

26   MRS SCHOLTENS:            that's right, but at the same time CSAC was a group
27   of experts, it knew it wasn‟t happening and it didn't say that.
     28/9/00                          C/ 971

 1   CHAIR: But they are outsiders. At some point you have to have someone
 2   within the Ministry who‟s got some drive and some authority, because as I
 3   see it the Ministry‟s a big organisation, there are competing priorities, and it
 4   would be one thing after 93 to go down to the people responsible for
 5   negotiating funding agreements and say, “this TELARC accreditation is
 6   really important”. They would equally be looking at a vast range of issues
 7   that they had to deal with. It seems to me that, unless you've got someone
 8   within the Ministry who can appreciate the importance and who has some
 9   clout within the Ministry, you're going to have a situation where advisory
10   groups may give advice but it doesn't seem to go anywhere. There's Dr
11   Teague‟s evidence, which I think is in the Royal College‟s submissions,
12   where he says it‟s not as if, when we said this, this and this should be done
13   they said no, it just went into this grey hole.     We gave advice, nothing
14   happened.

15   MRS SCHOLTENS:           Again, there's no difficulty with what you're saying,
16   but you've got to say what advice is Dr Teague talking about then, because
17   nobody advised that here in 1993/1994 there are still some laboratories
18   reading cytology for the programme, they're not TELARC accredited. What
19   did the experts say at that time – don't worry, they're getting there, it‟s OK.
20   Now these are experts groups appointed by the Minister. CSAC advised the
21   Minister. They are appointed under legislation, they are paid.        Their job
22   was to draw these things to the attention of the Ministry officials so they
23   could do something about it, and that‟s the way it worked back then. So, I
24   mean, it‟s not good enough that it didn't happen, but that is the situation that
25   the Ministry was working within.

26   CHAIR:      It‟s more really allowing that type of work situation to continue
27   for so long, that one can also stand back and question why.
     28/9/00                            C/ 972

 1   MRS SCHOLTENS:             It did seem to work well, to the people who were
 2   working with it, until 1996. So I just ask that you assess the situation as it
 3   was at the time and look at the different advice that was given.

 4   CHAIR: You see, when you look at things, if you go to the CSAC report of
 5   1994 I think it would be worthwhile going to it now because you can think
 6   about it overnight, I just have to find where it is.

 7   MRS SCHOLTENS:            Glackin volume 7, tab 34? This is their final report
 8   to the Minster before their new terms of reference.

 9   CHAIR:         If you look firstly at p3 they set out the key organisational
10   requirements        You‟ve got – if you tick them off – a central office or
11   individual responsible for planning, co-ordinating and evaluating the
12   programme. You had a national co-ordinator, but in terms of saying what
13   authority did she really have to plan to co-ordinate, to evaluate the
14   programme?

15   MRS SCHOLTENS:           Yes, well, I mean, -

16   [Tape turnover]

17   CHAIR: Let‟s look at laboratory reporting, because that‟s what we‟re here
18   to look at. Just tell me, from your knowledge, and I'm going back to that
19   Sunday when we had the panel of four, the impression I got was in terms of
20   laboratory reporting there wasn‟t any evaluation.

21   MRS SCHOLTENS:           In terms of the quality of the smear reporting?

22   CHAIR: Yes.

23   MRS SCHOLTENS:               Apart from those process monitors that we've
24   referred to?

25   CHAIR: Yes.

26   MRS SCHOLTENS:           That‟s right.

27   CHAIR: and the process monitors are?
     28/9/00                             C/ 973

 1   MRS SCHOLTENS:             Monitoring a turn around time, quality of smear –

 2   CHAIR: and colposcopy?

 3   MRS SCHOLTENS:             No, I'm thinking of what the register provided to the
 4   laboratories at that time, from the register.

 5   CHAIR:       Right, and so quality control of both smeartaking and smear
 6   reading.   “Agreed policy and set of objectives for the programme against
 7   which its success can be measured.” Well, certainly, you had objectives in
 8   terms of incidence and mortality rate, in terms of objectives relating to
 9   laboratory reading of smears and having a benchmark for sensitivity,
10   benchmark for specificity, that is there now in Peters but it wasn‟t before. I
11   will just go through this document. At the bottom of that p3 they say that
12   when the programme was launched many operational and legislative issues
13   had yet to be resolved, and then they list them:         no quality control for
14   laboratories, lack of agreement on number and type of programme, letters,
15   reports to doctors laboratories, no legislation to enable inclusion of histology
16   results on the register.

17   MRS SCHOLTENS:             Yes, and of course opt-off.

18   CHAIR:      Yes, opt-off, that's right, and I suppose if you want to put it in
19   there too, no clear legislative scheme which allowed for data collection of
20   the type necessary to monitor and evaluate laboratory performance.

21   MRS SCHOLTENS:             Yes, which I would connect to the opt-off, basically
22   not enough numbers.

23   CHAIR: That‟s right. And also, it seems to me, it needs to be accessible to
24   the people who need it. Then you get the concern in the next paragraphs
25   about the Area Health Boards and the impact that the 14 separate registers
26   had. In the next paragraph it says there, “Because the Ministry has not had
27   the authority or sufficient staff and resources to directly monitor local
28   registers, variations of procedures and data coding have occurred.” So you
     28/9/00                             C/ 974

 1   get a reference there to lack of resources and a concern about one Ethics
 2   Committee – that was the Wellington Ethics Committee that slowed down
 3   the first statistics report.

 4   MRS SCHOLTENS:             Yes, and went ahead without data.

 5   CHAIR:      That‟s what I mean about legislation not providing for effective
 6   gathering of data and use of data to allow monitoring and evaluation,
 7   because there you've got a situation where you want to do a statistical report,
 8   there's a first statistical report going out and you can't get information from
 9   the Wellington area because that regional Ethics Committee stops you,
10   whereas if you had a carefully planned legislative scheme there'd be no
11   impediment.

12   MRS SCHOLTENS:             Yes, although, to be fair, that problem was sorted out
13   pretty smartly.

14   CHAIR: Yes, that‟s true. I'm just using it as an example. Then you've got
15   over the page the uneven level of funding.        There is the talk, in the third
16   paragraph, about the health reforms impacting severely on the programme
17   with respect to national co-ordination, and the notation, further down, that
18   the programme has been impeded by staffing difficulties. If you look at p6
19   under the heading “Recommendations of the Advisory Committee regarding
20   monitoring and evaluation”, there's a reference in the second paragraph to
21   the committee being concerned that action is taken to ensure the availability
22   of timely and complete information from other services – for example the
23   Cancer Registry necessary for monitoring and evaluation.

24   MRS SCHOLTENS:             Yes.

25   CHAIR: Now, it seems that although they were concerned about that, no-
26   one could have got too far down the track there because they would have
27   encountered the obstacles that Cox/Richardson have encountered.           Either
28   that or there was a different approach in those days.
     28/9/00                           C/ 975

 1   MRS SCHOLTENS:                 Yes, I don't know that this problem that
 2   Cox/Richardson have faced has been encountered before.

 3   CHAIR:       No.   Whether that is because no-one‟s every attempted to do
 4   what they‟ve attempted to do before, or whether it‟s because in the past
 5   when others did the information has been more readily available, the
 6   evidence is silent on that.    I got the impression that no-one has actually
 7   done this clinical audit before in a national way, or even in any way.

 8   MRS SCHOLTENS:            Yes, I think the Ethics Committee took a different
 9   approach from the sort of approach that had been taken for other studies of
10   cancer data before.

11   CHAIR:       I know, it‟s in the protocol.   If you look at the protocol, the
12   protocol says there that –

13   MRS SCHOLTENS:          The Cancer Registry protocol?

14   CHAIR:       The protocol for the Cox-Richardson study that you've recently
15   made available, and I don't know off the top of my head the exhibit number
16   to it, but that has a narrative there that says that their evaluation was
17   basically the first one, and it says apart from special circumstances a
18   Cartwright, McLean and Ratima studies which are very small, a very small
19   number of people – 18 with McLean, 46 women with Ratima – nothing‟s
20   been done.

21   MRS SCHOLTENS:          Yes.

22   CHAIR: So I think we can take it nothing has been done.

23   MRS SCHOLTENS:           That's right, although of course the Cancer Registry
24   data relates to all cancers, so in terms of getting access to that Cancer
25   Registry this is a new problem.
     28/9/00                           C/ 976

 1   CHAIR: Yes, I know that, it‟s just, you see, as at 94 they are talking about
 2   the need to ensure availability of the information to allow monitoring and
 3   evaluation. It wasn‟t actually going on.

 4   MRS SCHOLTENS:           In terms of the cancer audit, yes.

 5   CHAIR: And then further down, the last paragraph: “An ongoing concern
 6   of the CSAC has been the need for the programme co-ordinating unit to be
 7   adequately staffed in order to fulfil its monitoring and evaluation functions
 8   effectively and in a timely manner. This need was first identified by Judith
 9   Stratton in her 1990 review of the programme.” Also emphasised by the
10   committee in recommendations to the Associate Minister of Health at the
11   end of 1993.

12   MRS SCHOLTENS:           Yes.

13   CHAIR:        And there was a special statement prepared on monitoring and
14   evaluation functions of the unit which identified appropriate capability,
15   expertise required within the unit were able to be exercised in a cost
16   effective manner.      And then when you go over the page, again they're
17   talking there under the heading, “Importance of Ongoing Monitoring”, about
18   an organised approach to cervical screening includes attention to all stages
19   of what has been referred to as the screening pathway, and they talk about
20   providing high quality laboratory services.      If you look at 21, appendix 3,
21   p46 of the same document it sets it all out in chronological order I think.

22   MRS SCHOLTENS:           And you want me to respond to this document?

23   CHAIR: Well, I think it‟s very important. There's the early experts group
24   document, there's a Ministerial group.        I think we should go to those
25   tomorrow because, you see, it fits in in two ways:            it fits in with these
26   theme that you develop in the submissions about hindsight bias. Is that the
27   name of it?

28   MRS SCHOLTENS:           That‟s the name, yes.
     28/9/00                           C/ 977

 1   CHAIR:       So it fits in with that because you're saying that all these
 2   criticisms are being done with the benefit of hindsight, but if you look at this
 3   material I'm saying it was being said at the time. It also fits in – in a sense
 4   you're saying, “well why wasn‟t CSAC saying anything?”, and what I‟m
 5   saying to you is, “well, look, if you look at this report, here are these people,
 6   they‟ve given a report.” If you go carefully through it, they're saying what's
 7   wrong, they're saying what's needed. They, in fact, have a section at p40,
 8   headed “Barriers to effective monitoring”, and they actually are critical of
 9   this reliance predominantly on advisory groups and they set out what the
10   barriers to monitoring are. So it seems to me they are actually saying to the
11   Ministry, “It‟s not working well using the advisory groups.”

12   MRS SCHOLTENS:           That's right. I certainly can deal with this tomorrow
13   ma'am.

14   CHAIR: Thank you.


16   PROFESSOR DUGGAN:               Mrs Sholtens, could I draw your attention to
17   p48 of this document, it‟s a recommendation on 15th December 1993, at the
18   bottom of the page.

19   MRS SCHOLTENS:          Yes.

20   PROFESSOR DUGGAN:                   Because this is a chronology of their
21   recommendations, right?

22   MRS SCHOLTENS:          Yes.

23   PROFESSOR DUGGAN:              So it‟s a request to the national co-ordinator for
24   information on total enrolments and proportion of eligible population
25   enrolled on an annual basis.          Also, they‟ve requested a number of
26   laboratories TELARC registered, or have applied for registration.

27   MRS SCHOLTENS:          Yes.
     28/9/00                          C/ 978

 1   PROFESSOR DUGGAN:             Laboratories not in these categories reporting to
 2   the screening register and the number of smears reported.        So this is 93
 3   when the expectation was that everybody would be TELARC accredited?

 4   MRS SCHOLTENS:         Yes, that's right.


 6   CHAIR: And they're asking to find out why?

 7   MRS SCHOLTENS:          They did get this information that demonstrated it
 8   all.


10   PROFESSOR DUGGAN:               Yes, but CSAC at this point is requesting
11   information? It appears they are following through on this?

12   MRS SCHOLTENS:         Yes, and they got it, so they knew. And the question
13   I guess is, well, what happened next?


15   CHAIR:     I suppose you have to say, too, is when an advisory group is
16   putting in reports and making comments and saying things about what they
17   think should/shouldn't be done – I think this is the final CSAC report
18   because after that you then got CSLAC.

19   MRS SCHOLTENS:             No, no, they got new terms of reference but
20   continued as CSAC.

21   CHAIR:       Anyway, this is their statement on the first 3 years of the
22   programme.

23   MRS SCHOLTENS:         Yes.

24   CHAIR: And you have to say, “Well, what more can they do?” I mean,
25   other than suddenly invoking some implicit shotgun clause, as Dr Duggan
26   says, where we say, “Well, we've told you there are things wrong, you're not
     28/9/00                             C/ 979

 1   listening to us so we‟re resigning” – you have to say, you know, “What can
 2   an advisory group do?”

 3   MRS SCHOLTENS:           Tomorrow?

 4   CHAIR: Yes, tomorrow. The other thing is I'm getting a little bit worried.
 5   I want to hear from counsel assisting.          There have been numbers of
 6   criticisms in other people‟s submissions.

 7   MRS SCHOLTENS:           Many numbers.

 8   CHAIR: Really, this is your opportunity to address them. As these issues
 9   come up I'm trying to tease out with you ideas that have been in our mind,
10   but I am conscious that all we have got so far is something on terms of
11   reference 1 and 2 and what is being said here at the moment, which is being
12   recorded.   If that‟s how the submissions are to be handled, I'm not
13   complaining, but I am worried about fair process and I just want to be sure
14   that at the end of the day the Ministry‟s view is, well, it‟s had an opportunity
15   to be heard, how it chooses to exercise that opportunity is up to the
16   minimum But if you're not going to go through dealing in a general sense
17   with the criticisms others have made, that‟s fine. I don't really want to take
18   on the task myself, therefore, of identifying those criticisms and putting
19   them to you.

20   MRS SCHOLTENS:           Yes.

21   CHAIR: I don't actually feel up to it at this stage.

22   MRS SCHOLTENS:           No.


24   MR MURRAY:          We've talked about this and we value this opportunity to
25   present oral submissions.       There is such a mass of material, we‟d actually
26   like an opportunity to audit criticisms and just come back with a written
     28/9/00                           C/ 980

 1   summary – it‟s not going to be controversial, and it may actually be a
 2   situation where we‟re not going to go blow for blow on each of these points.

 3   CHAIR: No.

 4   MR MURRAY:             Our approach is more to pick the high points and if
 5   they're wrong say why they're wrong, and an example of that was Mr
 6   Corkill‟s submission where he said during the whole of the period TELARC
 7   accreditation was not achieved.     Well, that was just wrong because it was
 8   achieved in 1997 with the contract that‟s been produced in evidence. And
 9   it‟s those sort of critical things. We tried to pick up some of those ones and
10   mentioned them, but I'm sure there's material there – some of it came in just
11   before the hearing.

12   CHAIR: Yes.

13   MR MURRAY:            I think in terms of fairness, we would just like to have
14   leave to come back with the written continuation, or I suppose some of it‟s
15   oral and it‟s in the transcript already now, but we are happy to put it in
16   writing and include on to it some of these points.

17   CHAIR:      See, the difficulty is that others are then going to have the
18   opportunity to respond to that.

19   MR MURRAY:            We don't want to get into a paper war and we‟re not
20   planning to do a very comprehensive exercise or be very controversial. It‟s
21   more for the panel actually. These are not contentious points.

22   CHAIR:     Where you do disagree – like points like what Mr Corkill says,
23   it‟s helpful if we know exactly what your position is and what the source of
24   that position is in terms of the support for it so that when we have to make a
25   choice we can. I'm just concerned that with material coming in after this
26   week, in the sense that Dr Duggan will be back in Canada and we will be
27   communicating by email, we haven't actually tried to start writing the report
28   yet because we thought we should wait until we've heard submissions, and
     28/9/00                          C/ 981

 1   of course the longer it is for material to come in that makes it difficult as
 2   well.

 3   MR MURRAY:          I don't think we‟re going to be holding you up. I think
 4   we've put in – I suppose we've put in more evidence than anybody else 10:1.

 5   CHAIR: Yes.

 6   MR MURRAY:          We've dealt with the controversial issues in our written
 7   submissions, but I do think that some of the material that we would just like
 8   to write up is more for the panel. It‟s just putting in evidence references for
 9   duRose and Medley material. It‟s some non-controversial material to round
10   off the Peters development, and I don't think you're going to be faced with a,
11   “Oh, we want to be heard again” situation, from what I plan on putting in.

12   CHAIR:     Well, I would like to know what the ameliorating factors are,
13   that‟s important, because it‟s important to look at the programme in its
14   context of historically and now.    I will go through your submission again
15   because if there are issues I'm particularly concerned about we will raise
16   those, and I would like to hear comment on the CSAC report. I would like
17   to hear comment on the contemporaneous material from people, which you
18   will find in the CSAC report. In the Cox exhibit Dr Cox put material
19   forward. My recall there is at one point there were a series of letters that
20   went off to the Minister as well because they were getting concerned. So,
21   maybe you don't want to comment on them, but I just want to make sure that
22   you have that opportunity.

23   MR MURRAY:          Actually we do want to comment on quite a few things,
24   but the process has slowed down because the panel has so many concerns.
25   I think, with the use of time tomorrow, if we could have a little bit of air
26   time and then if the panel could come back to us. Just looking at the
27   progress today it was extremely useful, but I know from the list that Mrs
     28/9/00                            C/ 982

 1   Sholtens has got, I think we‟re on to about .3 of 15 or 20 or something, so I
 2   think perhaps if we talk more and quickly in the morning.

 3   CHAIR: The concern is, though, that some of the things you say we have
 4   difficulty accepting, in the sense that I think it would be wrong to just sit
 5   here in silence and say nothing and then go away and write up a report that
 6   clearly rejects it.    By challenging you on these points it gives you the
 7   opportunity to then come back and say something more.

 8   MR MURRAY:            One thing about this process that we've been considering
 9   is whether a draft report is required.

10   CHAIR:      No, no, you've suggested that before, and the whole reason for
11   having a public process, with XXN and running it more like an adversarial
12   process, is to avoid a draft report.        And there was no draft report in
13   Cartwright.

14   MR MURRAY:            I know that, but I'm not going to be persuaded that where
15   you have a very complex inquiry like this there's two aspects to it: One is
16   natural justice. If the inquiry‟s report is going to be quite adverse, there will
17   be, inevitably, things there that – most issues we would have anticipated, but
18   not quite the way they're perhaps coming back.           The second point is,
19   because of the complexity of the subject matter the inquiry have done its
20   level best to document what it thinks the evidence establishes, but there have
21   been key errors that could impact adversely on our clients, or just be points
22   that the inquiry panel itself would not have made if somebody had read the
23   draft and said, “Oh, excuse me, you've overlooked exhibit such and such.”
24   So, in my submission, there are advantages to the inquiry panel, and to
25   parties who are adversely reported on, if a draft is made available. Now I
26   suppose I'm applying, if the report is going to be very adverse and there is a
27   risk of error that will compound the adversity.      Now, I can't say that you
28   must do that, it‟s a matter of the inquiry panel to judge, but I suggest we see
29   where we get to tomorrow.
     28/9/00                           C/ 983

 1   CHAIR:        Yes, certainly the Cartwright Report, which has featured a lot
 2   here, and which you have suggested in your submissions we adopt the tone
 3   of, was a report which was not circulated and which did, in fact, say some
 4   quite critical things about Professor Green and which did have a lot of
 5   evidence and some very complex issues – far more complex issues than this
 6   inquiry has had to deal with. So, I think that it is possible for us to write a
 7   report without circulating a draft report. I don't want, through force of
 8   circumstance, to find ourselves in a position where a draft report needs to be
 9   circulated because there hasn‟t been full submissions. This is a situation. I
10   mean, I like the oral tradition so I don't mind this, but I did make a ruling
11   that written submissions were to be filed by 1 September.         Some people
12   complied with the 1 September – well, I think it only the Royal College that
13   complied with the 1 September date, but others did manage to get their
14   submissions in and everyone else has filed written submissions in advance.
15   You have in respect of two terms of reference, not the other terms of
16   reference, and ultimately if you've given ample opportunity to file
17   submissions and ample hearing time – and you've had more hearing time
18   than others, because the whole idea of this hearing was people would speak
19   to their written submissions.     If, at the end of the day, you don't see
20   yourselves as having had the opportunity to be heard, in some ways it could
21   be said, “Well, the process provided for it but it wasn‟t availed of.”

22   MR MURRAY:           No, I think we always come last on the batting order, and
23   we do a lot of listening to everyone else and a lot of it‟s very critical, and
24   often we come down to the last part of the hearing and there's just a huge
25   array of material to deal with.    I don't see we've got a real problem, I just
26   think that tomorrow we might have to make our submissions more in bullet
27   point form.

28   CHAIR: Do you think we need to start earlier tomorrow?
     28/9/00                            C/ 984

 1   MR MURRAY:         Yes, probably, because we‟d like to be on a plane out on
 2   Friday night.

 3   CHAIR: Yes, we normally finish at 4.00 don't we on Fridays?

 4   MR MURRAY:          Yes, so we would be happy to start at I think about 8.30
 5   would we?

 6   CHAIR: Yes, Mr Hindle?


 8   MR HINDLE:        Ma'am, if I can say, of course as counsel assisting we want
 9   to answer any questions that you have, but having regard to the fair process
10   issues that you've raised, we are not a necessary component of that.

11   CHAIR: No.

12   MR HINDLE:       and we won't be in the slightest bit offended if we don't get
13   reached or if we only get reached and have to have a short period of time.
14   We are in your hands.

15   CHAIR: My understanding is that there are passages in your submissions
16   which are critical of the Ministry.

17   MR HINDLE:        The Ministry has had our submissions and will no doubt
18   pick up what they want to.      I just wanted to signal that my friend and I
19   aren't going to be in the slightest bit concerned if we get cut short, or even
20   don't get reached, because we've really tried to put what we wanted to say in
21   our submission and it is important that you have the debate with the
22   Ministry. We recognise that.

23   CHAIR:      No, I see that, too.      Mr Murray, you've got the submissions.
24   Counsel assisting, you described their submissions as the more neutral
25   submissions, but they, too, really are critical and they take different views of
26   certain actions than the Ministry does. So maybe if you‟d look at those
27   issues, because counsel assisting‟s submissions have been available, they
     28/9/00                           C/ 985

 1   were filed before your written submissions were. Really tomorrow is your
 2   opportunity to address those issues.

 3   MR MURRAY:         I mean, we‟re not being very combatitive about this issue.

 4   CHAIR: Oh, I know. No, you've made some very sensible concessions.

 5   MR MURRAY:          Yes. I just caution about concessions. Because it‟s not
 6   an adversarial process, sometimes you might say, “Well, we make a
 7   concession”, but whether that establishes the point is another matter.

 8   CHAIR:     Well, put it this way. At the moment I have taken the attitude,
 9   but if other people say that, for example, there are systemic issues, and I ask
10   you did you admit there were systemic issues.          If you say that there are
11   systemic issues, if other people say there are systemic issues in their
12   submissions and they draw attention to them, I'm going to accept that.

13   MR MURRAY:          Yes, I don't admit the systemic issues, I submit there are
14   systemic issues.

15   CHAIR: You submit there are systemic issues?

16   MR MURRAY:         Yes.

17   CHAIR: Whether you submit or not doesn't make any difference. The fact
18   is I just want to be sure that there's no controversy there.

19   MR MURRAY:           No, there's not a lot.     I think there's a huge array of
20   factual material which is not particularly disputed.

21   CHAIR: It‟s the inferences you draw from it.

22   MR MURRAY:           Well, it‟s how the panel writes them up, too, and that‟s
23   why we are focused on a submission which emphasises the approach the
24   panel should take, because at the end of the day, all of us that have
25   participated in the inquiry are in the inquiry panel‟s hands and the
26   judgement calls that are made about what's important and the balance that‟s
27   struck in writing it up. So we haven't invested a lot of time in batting point
     28/9/00                         C/ 986

 1   for point on issues which you will make a judgement on, and there's more
 2   than enough evidence, but what we have done is tried to address concepts,
 3   principles, approaches, reasons why things took so long, or something like
 4   that.

 5   CHAIR: One thing that does seem to me to be relevant that we have to go
 6   through and it may speed things up, if I refer you to the reports you look at
 7   them overnight and you can come back on them. One view I have is that
 8   there is sufficient contemporaneous material around to show that there were
 9   expert people whose advice one could say, “yes, this person knows what
10   they're talking about”, who was saying at the time that you need to monitor,
11   you need to evaluate, you need to have quality assurance for laboratories,
12   you need centralised control, you need to be using in-house persons that are
13   sufficiently knowledgeable and experienced rather than just relying on
14   advisory groups. It‟s not just a matter of looking back now and saying,
15   “Well, it‟s very clear that a programme, funded by the government, but
16   where there is a great reliance on outside advisory groups to move things
17   along, even though those advisory groups don't actually have any authority
18   to do so, is not going to be the most expeditious way of getting the
19   programme up and running effectively.

20   MR MURRAY:         I think some of those points are on your list and they're
21   on our list too, so we will address those tomorrow. As for start time –

22   CHAIR: Is 9.00 o'clock going to be enough?

23   MR MURRAY:        We will be here at 9.00.

24   CHAIR: Dr Duggan leaves on Saturday.


26   PROFESSOR DUGGAN:             Mr Murray, just to add to your burden, I am
27   mindful that Ms Mellor was going to bring us back some information on the
28   audit of the transcription on the Sydney re-read. Do you recall this?
     28/9/00                             C/ 987

 1   MR MURRAY:            Yes, that‟s on my list.

 2   PROFESSOR DUGGAN:               Excellent.

 3   MR MURRAY:            The work has been done, they haven't just produced to me
 4   what the outcome is, but I've been chasing it up so I will make it available.
 5   It‟s referred to in our submissions too, so we are nailed with that. I m not
 6   sure what format it‟s going to come back in, but presumably it will come
 7   back as a document that is readily able to be used by the inquiry panel to
 8   indicate the process it went through and what the outcome was.

 9   PROFESSOR DUGGAN:               This is something Professor McGoogan drew to
10   our attention that we needed to be wary of.

11   MR MURRAY:             Yes.    Tracey Mellor‟s overseas but I know somebody
12   else has been working on the exercise, I just haven't seen the outcome but I
13   will push it again.


15   CHAIR: We will adjourn until 9.00 a.m. tomorrow.




19                 THE HEARING ADJOURNED AT 5.00 P.M.,

20                             TO RESUME AT 9.00 A.M.

21                           FRIDAY 29 SEPTEMBER 2000