1 INQUIRY HEARING RESUMES AT 9:35 A.M.
2 WEDNESDAY 2 AUGUST 2000
4 CHAIR ADDRESSES INQUIRY
5 CHAIR: The first issue to deal with is the recall of witnesses. I have
6 decided to deal with this one step at a time and the first step I will make is to
7 direct the summonses be issued to Dr Linehan and Dr Hasan. I will give
8 reasons in a moment. At this time though the orders that the witnesses make
9 themselves available are no guarantee that they will be heard because we
10 already have as I’ve said before a tight schedule and the other witnesses
11 scheduled for hearing this week must be heard. We also have received
12 notice that someone from the kaitiaki group wishes to be heard and it is very
13 important that someone from that group is heard in view of the concerns that
14 have been expressed to the committee about the impact of the kaitiaki
15 regulations and the workings of that group on access to maori non-aggregate
16 information. We have also asked for Dr Boyd and Ms Glackin to come back
17 and I envisage that will take time as well and I’ve had an indication that an
18 Ethics Committee may wish to make submissions. I’m not sure what the full
19 extent is of this but Mr Hindle has advised me that a Solicitor representing a
20 group of Ethics Committees has been in contact with and there therefore is
21 the potential that someone may appear from that group and I do not want at
22 this stage to be in a position to deny an opportunity to a witness to be heard
23 concerning matters that have arisen in respect of Ethics Committees and the
24 impact they have had on access to information so taking all those things into
25 consideration, I cannot give a guarantee that Dr Linehan and Dr Hasan will
26 be heard, however at the same time it seems to me especially as an order I
27 understand is required for Dr Hasan and the requirements under the
1 Commissions of Inquiry Act that service of such an order be made 24 hours
2 before the witness is to appear, we have to act promptly in order to ensure
3 that he can be available. The other point is the order must I think provide
4 for him to appear on Friday because I have misgivings about whether or not
5 the committee has jurisdiction to order a witness to appear in hours outside
6 normal Court hours. I haven’t had the opportunity to clear that issue up and
7 I would therefore rather err on the side of caution and if I’m going to issue
8 an order compelling attendance, do so in circumstances where I consider
9 there is jurisdiction to do so. So therefore the orders will require Dr Hasan
10 and Dr Linehan to attend on Friday. If however both or either of those
11 persons indicate a willingness to attend on Saturday, that certainly is the
12 committee’s preference to have their evidence heard then. The other point is
13 that these are practical points but I do not think that the summons can be
14 issued in such a way that Dr Hasan is Mr Grieve’s witness. If he comes as
15 Mr Grieve’s witness, his evidence has to be lead by Mr Grieve, equally as
16 Mr Grieve’s witness, his testimony has to be accepted by Mr Grieve because
17 Mr Grieve cannot impugn his own witness. I therefore consider that Dr
18 Hasan should be called as a witness by counsel assisting. That will give Mr
19 Grieve as well as other parties a free opportunity to explore issues with Dr
20 Hasan in circumstances where the obtaining of the evidence is not
21 circumscribed by rules relating to obtaining evidence in chief and where
22 there is no issue about impugning a witness. I don’t see that there is any
23 need to call Ms Wilson any further. I’m aware of the issues that Mr Grieve
24 raised and my view is that the information in terms of the number of smears
25 sent to the Hamilton Laboratory and the number of abnormalities can be
26 obtained by Dr Hasan if he make the necessary inquiries and indeed under
27 the Commissions of Inquiry Act Section 4D a committee of inquiry with the
1 commission of inquiries powers can compel a witness to attend not only in
2 person but to bring such information as will allow the committee of inquiry
3 to come to it's decision therefore Dr Hasan should be required whatever
4 records can be brought to show how many smears have been obtained from
5 Gisborne. The wording of the subpoena is therefore going to take a bit of
6 care but I want to have it done obviously as soon as possible. I understand
7 Mr Grieve you’ve got an electronic copy of the subpoena which you could
8 make available to counsel assisting so that it can be converted into a fresh
10 MR GRIEVE: Yes I’ve got hard copies here but it was not in subpoena
11 duces tecum form which we will obviously need to amend.
12 CHAIR: I think we will, I think the best way to deal with this is to issue
13 a subpoena duces tecum to Dr Hasan, that way you will get the necessary
14 records and it will mean we only have to deal with two witnesses rather than
15 having Ms Wilson come back.
16 MR GRIEVE: I’m happy with that Madam Chair in fact I had
17 indicated to Mr Hindle, I don’t know whether he’s passed it on to you, but if
18 Dr Linehan was provided with the appropriate information then that would
19 obviate the need to call the second witness so it's just a matter of getting the
21 CHAIR: Right I wasn’t told that. What I’ll do, our of caution because
22 we only have this week, is issue orders under Section 4D to both parties, but
23 in circumstances where they can be approached and if on a co-operative
24 basis one of them can come along and that would need to be Dr Linehan to
25 suit Mr Kirton and provide information in a form in which you are happy
26 with, then that will be acceptable to the committee of inquiry and certainly in
1 terms of the time pressures we are under, it would give a better reassurance
2 of having a witness heard.
3 MR GRIEVE: Yes thank you Madam Chair.
4 CHAIR: Well I know briefly read out the reasons. While under cross
5 examination by Mr Grieve and in circumstances where Mr Kirton had
6 indicated a wish that he would want to cross examine Dr Linehan as well, Dr
7 Linehan’s evidence came to a halt on Saturday afternoon. Mr Grieve and
8 Mr Kirton have now indicated that they seek to have Dr Linehan and Ms
9 Wilson recalled to continue giving evidence and to have Dr Hasan give
10 evidence. I have now learned as a result of information today that it may not
11 be necessary for Dr Hasan to be called, however in all the circumstances
12 because of the pressure of time and because if a subpoena is not served by
13 10 am tomorrow it may not be possible to compel either persons to attend as
14 witnesses, I intend to err on the side of caution and to direct that orders be
15 issued under Section 4D of the Commissions of Inquiry Act requiring the
16 attendance of Dr Hasan and Dr Linehan and in respect of both of those
17 witnesses, they are required not only to present themselves to the committee
18 of inquiry but also to bring with them such documentary evidence as would
19 inform the committee of inquiry as to the number of smears from Gisborne
20 sent to the Hamilton Laboratory after March 1996 and the numbers of those
21 smears which have turned out to be read as high grade abnormal smears and
22 also any other documentation which would relate to whether or not there had
23 been any reconsideration of earlier smears. In case there’s any
24 misunderstanding requires the witnesses to produce documentary evidence
25 of the smears sent from Gisborne to Hamilton in the period since March
26 1996. Now that could be computerised records of how many smears have
27 been sent, it could be copies of records from daybooks whatever. The
1 committee wants to be in a position where it knows accurately how many
2 smear tests have been sent from Gisborne to Hamilton for the purposes of a
3 smear report. We do not need to have individual smear reports but rather the
4 documented evidence of how many have been received and we also want to
5 know how many of those received have been found to be a high grade
6 abnormality and any documentary evidence which will do that will be
7 sufficient. We do not need to identify the women or have individual smear
8 reports. The reason, I will continue now with the reasons for making these
9 orders, dealing with Mr Kirton’s application first because he applied first
10 yesterday. He applied to recall Dr Linehan because he indicated that he wish
11 to question Dr Linehan about questions of medical ethics. Dr Linehan is the
12 former chair of the New Zealand Medical Ethics Committee. Mr Kirton
13 advises the committee that the Women’s Health Information Trust which he
14 represents treats the issue of professional behavior and medical ethics as a
15 key and fundamental consideration of the inquiry. Throughout the inquiry
16 the trust has questioned witnesses on matters of medical ethics in relation to
17 the Cervical Screening Programme. His submission raised concern to Mr
18 Murray, counsel acting for the Ministry of Health and Health Funding
19 Authority and counsel assisting the committee and indeed the committee
20 itself, in relation to how far the trust may go to pursue a submission on
21 medical ethics and professional behavior. However the committee considers
22 that the length to which the trust can take it's submissions on this point is an
23 issue that is best left to hearing on submissions. The committee does
24 however wish to make it known that it is well aware of the obligations to
25 comply with the rules of natural justice and it will not accept submissions
26 which would result in the committee contravening those rules. It is simply
27 that the committee considers that it is premature at this stage to close down
1 evidence which may be able to be used in one shape or another. As the
2 former chairman of the New Zealand Ethics Committee Mr Linehan may be
3 able to give evidence on whether or not Dr Bottrill by continuing to practice
4 after his heart bypass operation has breached any ethical requirement. There
5 is also the question of ethical responsibility regarding the storage of patient
6 records in circumstances where one laboratory has been taken over by
7 another. Had it not been for the interruption of Dr Linehan’s evidence on
8 Saturday, Mr Kirton would have had the opportunity to explore these issues.
9 If the committee were not pressed for time Mr Kirton would have had the
10 opportunity to explore these issues. In these circumstances the committee
11 considers that if there is opportunity to hear from Dr Linehan, Mr Kirton
12 ought to be afforded the opportunity to question him on the issues that he
13 has indicated to the committee of inquiry. The committee notes the Trust
14 has not provided its own expert witness on matters of medical ethics, and the
15 committee does not accept Mr Kirton’s submission that the Trust relies on
16 Dr Linehan’s evidence in circumstances where, if he were not called, it
17 would have called a witness of its own. At this time, it appears to the
18 committee, that Mr Kirton has no indication of what Dr Linehan is likely to
19 say on these matters, and it seems that Mr Kirton is simply relying on the
20 opportunity Dr Linehan’s presence in the Inquiry presents to raise these
21 matters with him. However, the committee is aware that the Trust is not
22 well funded and it may have had difficulty obtaining its own expert
23 witnesses. If it wants to explore issues which it treats as key issues, through
24 witnesses called by other persons, that is its choice. Because the issue of Dr
25 Bottrill’s ethical responsibility and the issue of storage of records is of
26 interest to the committee, the committee considers that at this time
27 endeavours should be made to have Dr Linehan’s evidence if it is possible.
1 They emphasise again that that is not to be taken as a guarantee that he will
2 be heard. The Committee of Inquiry will sit until 12.30 on Saturday and if
3 we have not heard from Dr Linehan until then, then that opportunity will be
4 lost. There is only one possibility which will make the Committee of
5 Inquiry sit beyond 12.30 on Saturday and that is, they’ve asked that Dr Boyd
6 and Ms Glackin be recalled and be available for questions to be put to those
7 witnesses concerning material that other subsequent witnesses have given in
8 evidence to the committee which may be interpreted as being critical of the
9 Ministry of Health and Health Funding Authority. If we reach 12.30 and it
10 should happen that Dr Boyd or Ms Glackin is in the middle of giving
11 evidence and there are still issues to be canvassed with those witnesses,
12 which it is important to canvass with those witnesses, for the purposes of
13 procedural fairness we will sit on. But that is the only basis upon which we
14 will sit on. Mr Grieve has indicated that he wants to recall Dr Linehan for
15 reasons different from that of Mr Kirton, and he originally wanted Ms
16 Wilson and Dr Hasan, but I now understand it may be that Dr Linehan will
17 do, and certainly he no longer seeks to have Ms Wilson recalled. The issues
18 which he wants to pursue with these witnesses is whether or not, if the
19 practice of Medlab Hamilton had involved a “look-back” of smear history,
20 on discovery of an abnormal smear from a woman from Gisborne, the
21 quality of Dr Bottrill’s reporting may have come to light sooner. This is
22 relevant to terms of reference 4, 5 and 6. The cytopathologist, that is Dr
23 Hasan, who has been at Medlab Hamilton since 1997, will be able to say
24 how many abnormal smears were read at that laboratory from Gisborne and
25 what steps were taken to look back at previous history. Alternatively, if Dr
26 Linehan fully acquaints himself with the information, he will be in a position
27 to give that evidence. The committee does not think it will be necessary to
1 have Ms Wilson give any further evidence. The cytopathologist can
2 provide sufficient evidence if he acquaints himself with the laboratory
3 records and brings those with him to the Inquiry. For those reasons, the
4 Committee of Inquiry has decided to issue the two orders that it does under
5 s4(d). Now Mr Grieve, I’m aware that the orders have to be served within
6 24 hours. Because of my concern about jurisdiction I’m making it 10.00am
7 Friday, because 10.00am Friday fits in with court hours. The other issue is,
8 though, it is personal service, which means that the orders are going to have
9 to be completed today and got to someone who is in a position to serve them
10 by 10.00am tomorrow. Both counsel assisting are fairly stretched, so
11 although I've said that Dr Hasan and Dr Linehan will not be your witnesses,
12 can you offer facilities to help with those practical matters of getting the
13 sub-poena to someone who can serve it by 10.00am tomorrow?
14 MR GRIEVE: Well, I will have to do that Madam Chair.
15 CHAIR: Well, I can't compel you, they are not your witnesses, I'm just
16 asking you if you would.
17 MR GRIEVE: Well, someone’s got to do it, and I will see to it that it’s
18 done Madam Chair, even if I've got to do it myself.
19 CHAIR: I would be grateful.
20 MR GRIEVE: I just didn't bring my bike down to Gisborne!!
21 CHAIR: Well, let me just say, don’t serve the orders personally, because if
22 no-one appears and you have to prove service, you will then disqualify
23 yourself as counsel.
24 MR GRIEVE: I would have thought that the Ms Marshall precedent would
25 perhaps obviate the need for the application of that rule, Madam Chair.
26 CHAIR: The next issue is the legal issue about whether or not the
27 Committee of Inquiry can, using its powers under the Commissions of
1 Inquiry Act, obtain access to certain information which includes information
2 on the Cancer Register, the National Cervical Screening Programme
3 Register, and medical records. Is there any agreement about the order in
4 which people will be heard?
5 MR HINDLE: Yes, ma'am, I think in view of information that I'm about to
6 give you, it’s appropriate that I go first, and I don’t think anyone objects to
7 that. I have circulated, I’m afraid only just before the hearing, a written
8 submission together with some materials which include a spiral bound
9 volume of the Health Information Privacy Code. I would like to record my
10 appreciation to the Privacy Commissioner, Mr Slane, who is here today, for
11 providing copies of that document. It is the most “hot off the press” version
12 of the Code; I see that it includes amendments commenced on 30 July 2000.
13 So, on the 2nd August, that’s not doing too badly. And it contains not only
14 the Health Information Privacy Code, but also towards the end, a very
15 helpful collection of extracts from various statutes. So my thanks to Mr
16 Slane for that. Now ma'am, I have done some work and thought about the
17 issue, but I’m bound to tell you that it now appears to me that it is entirely
18 academic, for a reason which I need to explain. It is this: I spoke to
19 Professor Skegg last night and he informed me that in his discussion with
20 the Cancer Register yesterday, to just get an update on how many cases there
21 were, he learnt for the first time that there are now 61 registrations of
22 cervical cancer in the Tairawhiti area since 1999. That breaks down to 44
23 in the period between 1990 to 1997; 1 in 1998; 10 in 1999, and to date, in
24 the year 2000, a further 6 – making a grand total of 61. Professor Skegg
25 says that, with the best will in the world, he cannot do his study on 61 cases
26 in 32 working days. Therefore, it seems to me to be appropriate before I
27 embark on the whole issue of whether or not there's a power to indicate that,
1 it really isn't going to happen now before 18 September and I’m reluctant to
2 take the committee’s time in addressing the legal issues on that basis.
3 CHAIR: Well, it struck me that there might be difficulty because the only
4 way I had thought to be able to get the information was going to be
5 cumbersome. But it also struck me that we don’t report until 20 December,
6 and as what we would be getting is a clinical audit from Professor Skegg, to
7 receive it later in the year and circulate it around parties may also suffice, in
8 terms of procedural fairness, and we can then, even if we annex it as an
9 appendix to our report. As I see it, we could make some use of a study by
10 Professor Skegg if we had received it by December.
11 MR HINDLE: There’s no question about that, ma'am, and I’m happy to
12 run through the submission that I prepared, but it was on the footing that 18
13 September was the date by which the material would really need to be ready.
14 CHAIR: Well, obviously, that would be the ideal time, because that’s when
15 submissions start, but I think that this is an exercise that we must at least
16 attempt to see how far we get. I must say, as I prepared for this myself last
17 night, I became very concerned about the whole issue of the unavailability of
18 information which on my reading of Dr Cox’s evidence was known to the
19 Ministry of Health last year, was not clearly brought to our attention. I first
20 became aware of the issue as a result of questioning Professor Skegg when
21 he gave evidence at our first hearings and I consider that something as
22 important as this ought to have been brought to the committee of inquiry’s
23 attention sooner and I am certain that is one of the issues I intend raising
24 with Ms Glackin or Dr Boyd, how it came about that we did not learn of this
25 fundamental obstacle to an evaluation of the programme going ahead until
26 Professor Skegg was here and if we had learned at the beginning of this
27 inquiry we would certainly have the study done by now.
1 MR HINDLE: I am bound to say that is so and there would have been
2 more time. But ma’am as I say I am very happy to address the legal issues
3 and the other practical issues if you would hear what I have to say on the
4 footing that I had thought 18 September was a deadline I will run through
5 this submission because I know there hasn’t been much time to read it but
6 this is my attempt in, dare I say it, some difficult circumstances in terms of
7 resources in time to collect my thinking on this issue.
8 CHAIR: I’m not interested in the preliminary matters. I mean it's
9 helpful to have them in the submission but there's no need to go through the
10 preliminary matters. What I’m interested in is the law and I’ve read the
11 Crown Law opinion and what I’m interested in is to see what powers you
12 consider the committee of inquiry has.
13 MR HINDLE: Yes ma’am well I’ll go straight to paragraph 8 then.
14 I’ve included a bundle of materials and Section 4C is in amongst those
15 materials. I’ve said in paragraph 8 that the wording of Section 4C itself is
16 straightforward, the committee or any person authorised by it in writing may
17 amongst other things require any person to produce for examination any
18 papers, documents, records or things in that persons possession or under that
19 persons control and to allow copies or extracts from any such papers,
20 documents or records to be made. Now on the face of the section it certainly
21 appears to be within the committee’s power to authorise Professor Skegg
22 and his colleagues to require those that have provided health care for
23 women how have had a diagnosis of cervical cancer in the Tairawhiti area
24 since 1990 to produce relevant papers etc in their possession for examination
25 and copying. I note that what is needed from the committee is a document
26 which authorises a person in this case Professor Skegg, to require any person
27 in the present case the health care providers who have attended each of the
1 women involved to produce documents and so on for examination and also
2 to allow copies to be taken. It's not a situation where orders in the sense are
3 required and I make the point that the procedure is different from the usual
4 discovery procedures under the District Court Rules. It's suggested in the
5 Crown Law Opinion that in order to proceed Professor Skegg would in some
6 sense need to become an agent of the committee. However in my
7 submission this is not something that is required to comply with Section 4C,
8 it's not something that would seem to me to be either necessary or desirable.
9 Section 4C 1b allows the committee to confer authority to require the
10 production of things for examination and I submit that that's wide enough to
11 include the smears that are required for panel review if it comes to that the
12 committee will remember that Professor Skegg had proposed in the case of,
13 when doing his look back, if there were smears that needed to be reviewed
14 there would be a panel and so on and soforth and I say that that section is
15 wide enough to facilitate that. I say that any authority or authorities will
16 need to be drafted with care amongst other things it will be necessary to
17 identify exactly who is to be given the authority, to whom requests for
18 information are to be directed and what information will be required from
19 those who are asked to provide information. There may be practical issues
20 in trying to find those who hold the relevant data or to trace sources of data,
21 for example where more than one health care provider has been involved or
22 whether a woman has moved or changed her name but I say that before
23 dealing further with those practical aspects, it's necessary to consider
24 whether other legislation relating to the type of information in question, that
25 is personal health information, restricts the effect of Section 4C in a material
26 way. I start with the Privacy Act and the Health Information Privacy Code.
27 The Privacy Act was enacted in 1993. The Health Information Privacy Code
1 1994 is promulgated under Section 46 of the Privacy Act, it applies to the
2 information about the health of an identifiable individual including his or her
3 medical history and the clauses I’ve referred to are to be found at page 9 of
4 the document that's provided by Mr Slane. These include any agency which
5 provides health or disability services, an agency is defined in Section 2 of
6 the Act in very wide terms. I suggest it's unlikely that any of the information
7 which Professor Skegg needs to have access to will be held by anyone or any
8 entity other than a health agency except of course the woman who wouldn’t
9 be directly approached. The Act sets out 12 principals that govern the
10 collection, storage and use of personal information. Principal 6, access to
11 person information and 11, limits on the disclosure of personal information
12 are the relevant principals for present purposes. Section 71 of the Act
13 provides that nothing in those principals derogates from any provision in any
14 other enactment or authorises or requires personal information to be made
15 available and on that basis I submit that there is nothing in the Privacy Act
16 or the Health Information Code to restrict the effect of Section 4C of the
17 Commissions of Inquiries Act or which would apply to prevent the
18 committee from exercises powers under the commissions of inquiry -
19 CHAIR: Mr Hindle could you pause there have you got a copy of the
20 Commissions of Inquiries Act.
21 MR HINDLE: There's an extract amongst the materials ma’am and
22 Section 4 is amongst them. I have the full Act if you require it.
23 CHAIR: Well at the moment I can’t even find the extract and I’ve lost
24 my own extract.
25 MR HINDLE: I’m happy to hand up my copy of the entire Act.
26 CHAIR: It all right I’ve found my own extract.
1 MR HINDLE: I say I apologise ma’am that these copies of the status
2 database version of the Acts but that was the best I could do on Sunday.
3 CHAIR: Look I’ve read – I’m sorry to cut you short but I’m worried
4 about time. I’ve read your submission and it seemed to me that from your
5 submission of the Crown Law opinion – it seemed to me that your
6 submission is in line with the Crown Law opinion that the very specific
7 provision in Section 74A of the Health Act would override the more general
8 power in Section 4C of the Commissions of Inquiry Act.
9 MR HINDLE: That's so ma’am and like the Crown Law opinion I have
10 suggested that one needs to approach that conservatively because whilst the
11 matter is not clear cut, if in fact it were to transpire that that view is correct
12 i.e. that the Commissions of Inquiry Act is subordinate to the provisions of
13 Section 74A, then for anyone to actually disclose information is an offence.
14 CHAIR: Yes, I note too that the Crown Law opinion, and this is where
15 I’d like to hear from you because it doesn’t persuade me at the moment, it
16 goes on in paragraph 27 having saying the view set out above in paragraph
17 26 is conservative, it then goes on to say how it may be possible to bring
18 disclosure within the scope of 74A 5 and that if that is – it then goes on to
19 say if that interpretation is wrong then 4C will prevail over 74A 5 and I fail
20 to understand that reasoning. There seems to be a shift in the logic from
21 para 27 on, which is at odds with what is set out in para 26, and I found it
22 difficult to make sense of what was said in paras 27 and 28.
23 MR HINDLE: Yes, ma'am, I must say that’s why I didn't just simply say I
24 adopt those paras, because I had some trouble with that sentence in 27 as
25 well. That was why I approached it by asking, first of all, which Act
26 prevails over which Act, and then if we can find out what that is, is there a
27 relevant exception in s74A
1 CHAIR: The point is this: I don’t think there is an exception in 74A
2 because when you look at the exceptions in 74A(5), the suggestion, for
3 example, “that part of the study will be for the purposes of compiling
4 statistics to be provided to the Inquiry, and as long as the view is properly
5 and reasonably held that should be sufficient.” Well, I think that the Skegg
6 study goes much further than providing statistics.
7 MR HINDLE: Ma'am, if I can indicate that I agree with that. I specifically
8 raised the issue with Professor Skegg last night and I can say I read out para
9 39 of my submission to him and he agreed with it. I have really come to the
10 conclusion that it would be artificial to ask him to go away and just prepare
11 “statistics”, because what we really want from him is some qualitative
12 judgements about what's happened, so I agree with you, I don’t think there is
13 an exception in 74A
14 CHAIR: Well, if I could just perhaps sound out with you – I will certainly
15 listen to you and to what anyone else has to say, but just for the purposes of
16 short-circuiting matters, if I could give you an indication of what I saw as a
17 way around it, because it is cumbersome. I noted the legal authorities in
18 para 23 of the Crown Law opinion, and you’ve referred to them as well in
19 your submission in para 24, where the courts on more than one occasion
20 have found that a provision similar to 74A(5) does not prevent the giving of
21 evidence in proceedings. Now, I haven't had a chance to read those cases
22 thoroughly, have you?
23 MR HINDLE: I haven't read either of those two cases because, to be honest
24 ma'am, I came to the conclusion that it was what Professor Skegg would be
25 being asked to do is too distant to be described as “giving evidence” in any
1 CHAIR: I have no intention of treating it way. You see, under s4(d), a
2 Committee of Inquiry has the power to issue sub-poenas and sub-poenas
3 duces tecum. If we can identify from Professor Skegg what the material is
4 he needs for his study, we can issue sub-poenas using s4(d) and if the Crown
5 Law interpretation of these cases is correct, to have witnesses from the
6 Screening Register, the Cancer Register come along to produce the
7 necessary material which we will then accept as evidence and give to
8 Professor Skegg for the purposes of him examining that material under 4(c)
9 and providing us with a report. That, to me, is the only way we can get the
11 MR HINDLE: Ma'am, I’m bound to say this about that, it does have the
12 complication that it necessarily means that you will then be seized of a lot of
13 personal health information with names.
14 CHAIR: That’s right, but I have the power to do that as a Committee of
16 MR HINDLE: I agree in respect of everything except what is in the
17 Screening Register, which is that sort of ironic exception.
18 CHAIR: I don’t understand you. My understanding of what Crown Law is
19 saying, and I haven't read the cases and I would want to read the cases, but
20 my understanding of what they say in para 23 is that there are reported
21 decisions – for example, if you look at para 23 it refers to a Court of Appeal
22 judgement, Q v Bainham concerning s62 of the Hospitals Act which
23 provided – and I’m relying on Crown Law to be accurate here – “no person
24 employed by a Hospital Board shall give to any person not employed by the
25 Board any information considering the condition or treatment of any patient
26 in any institution of the Board without the prior consent of the patient or his
27 representative.” And the opinion goes on to say, “in that case the Crown
1 called a hospital doctor as a witness in a criminal trial with a view to
2 obtaining evidence as to an examination made by him of the accused. The
3 Court of Appeal held that such evidence was admissible, notwithstanding
4 absence of the patient’s consent.” And then it goes on to refer to other
5 cases. I think there's Human Rights case – have you got a copy of that?
6 MR HINDLE: It’s amongst the materials there, ma'am.
7 CHAIR: I might be able to pick that up. Because it seemed to me it’s
8 clumsy, but if this opinion is right and if the power under s4(d to summons
9 witnesses to give evidence overrides s74A, we can by very cumbersome
10 process issue summonses to a series of witnesses to produce – because we
11 can have papers, documents, records or things in the person’s possession –
12 get in the base information and then make it available to Professor Skegg.
13 That was the old way, when you couldn't get non-party discovery and you
14 knew that someone who was not a party in proceedings had information that
15 you needed in the proceedings, that’s how you got hold of it.
16 MR HINDLE: It effectively amounts to a sub-poena duces tecum for their
18 CHAIR: That’s what it is.
19 MR HINDLE: Yes, ma'am, my immediate reaction is that I’m not certain
20 that would necessarily overcome the s74A hurdle in relation to information
21 on the Screening Register because if the argument is right that the Screening
22 Register – no disclose of information, I suppose that’s right, it is a step
23 removed to say that you are asking for evidence not information.
24 CHAIR: It becomes the evidence, it is the evidence.
25 MR HINDLE: I am bound to say, ma'am, that I suggest there are some
26 really difficult practical issues with that, not the least of which is that you
27 would be obtaining information which would be thought of by most people
1 to be at least confidential and which might be protected by s32 of the
2 Evidence Amendment Act number 2.
3 CHAIR: Well, I can't see that for a start because, firstly, in terms of the
4 confidentiality and privacy, Courts and Commissions of Inquiry and a
5 Committee of Inquiry, having the powers of a Commission of Inquiry,
6 regularly receive confidential information. We are quite capable of issuing
7 orders to protect that information. In terms of s32, I agree with the Crown
8 Law opinion because I've had reason to look at this myself; it is the
9 communications to a medical practitioner that are protected, not the
10 communications by a medical practitioner. Therefore, the patient notes, in
11 so far as they record what the medical practitioner has observed, diagnosed
12 and written down, are not covered by s32. So, it’s cumbersome but I think
13 we should try it. In terms of the practical problems it presents, I intend
14 raising this with Mr Murray who had hoped he wouldn't have to say
16 MR HINDLE: Ma'am, I'm bound to say that it leaves me wondering – I
17 suspect I know the answer, but who is it that’s going to go through those
18 records and make sure that there is no disclosure to the Inquiry – no, I
19 suppose the first question is whether the Inquiry is a civil proceeding, caught
20 by s32 of the Evidence Amendment Act.
21 CHAIR: yes, we are.
22 MR HINDLE: If that is accepted, then s32 makes it perfectly clear that no
23 medical practitioner can release protected information to you. So at some
24 point someone’s going to have to go through those files and figure out what
25 can't be given in evidence and what can.
26 CHAIR: Well, the law is quite clear on this because they’ve had to deal
27 with it quite a lot. I know with these communications it comes up in a
1 number of matters I've had to deal with it, and I know for sure that it is only
2 what the patient tells the doctor that is protected. Now, we will just go
3 through a process – this is why I said it would have been very good if we’d
4 known about this at the outset of this Inquiry. It is quite possible for us to go
5 through a process of having a series of witness appear, produce information
6 and claim privilege, and that privilege part can be deleted and we can accept
7 it in a sanitised form. You may have to work with them to do it; they may
8 choose to do it, but it can be done.
9 MR HINDLE: I don’t disagree. Certainly, it can be done as a matter of
10 principle, I don’t argue with that. I'm bound to say, ma'am, that at some
11 point – and I suspect these submissions may not attract themselves much to
12 you, but I have tried to deal with certain practical aspects of what's involved
13 and to make the point that at the end of the day the committee does have a
14 discretion here to weigh up whether or not this is in fact sufficiently
15 necessary on the current state of the evidence that you have before you. To
16 do something which is cumbersome is going to be time-consuming and
17 which does involve an intrusion into doctor/patient confidentiality and raises
18 issues of s32. It’s not a matter for me to decide, but at the end of the day it
19 does come down to a discretion and I submit that the committee would want
20 to be quite satisfied that this was really very necessary in order to deal with
21 the terms of reference to undertake the work.
22 CHAIR: Yes well what concerns me about that Mr Hindle is that the
23 terms of reference ask the committee to look at under-reporting in the
24 Gisborne region. We have to look at whether or not there’s been an
25 unacceptable level of under-reporting and consequence of misreading and/or
26 misreporting of abnormalities and cervical smears in the Gisborne region.
27 I’m told that the gold standard way of auditing a screening programme is
1 this clinical audit. I’ve heard a lot of evidence concerning Dr Bottrill, I’ve
2 heard nothing about any other laboratory. I have however read patient files.
3 I’ve now read two patient files where patients have had smears read by Dr
4 Bottrill as normal that were later found to be high grade, sandwiched in
5 between the smears read by Dr Bottrill and the ultimate diagnosis of cancer,
6 has been a smear test read by the other laboratory in Gisborne. I’ve seen that
7 on two occasions. Now two occasions is not enough to make the committee
8 think there may be a problem beyond Dr Bottrill but the point is we simply
9 do not know. If those two smears were read wrongly and we don’t know
10 whether they were or not, it could have something to do with smear-taking,
11 it could be that by that stage there was cancer there and we know that cancer
12 there can be a 50% false negative rate and the third possibility is that there
13 was a misreading by the Gisborne hospital laboratory. I’ve also seen another
14 patient effected/witnesses records where I saw that Dr Bottrill recommended
15 that she be sent for assessment and she wasn’t so again in terms of systemic
16 problems surrounding the programme I haven’t had a great deal of
17 information. So far there’s been a porosity of it but there is something there
18 to make the committee concerned that the problem is not just limited to Dr
19 Bottrill. The other point is that the DuRose study was limited to community
20 laboratories, it did not look at hospital laboratories therefore the only way
21 that we can be sure as to whether or not mis-reading, mis-reporting of
22 abnormalities in the Gisborne region is related to Dr Bottrill’s laboratory is
23 in fact this clinical audit because if there has been mis-reporting by others in
24 the region, the clinical audit will show it up.
25 MR HINDLE: Yes ma’am I’ve always accepted that the study would
26 have those benefits of course. I’m bound to say without wanting to sound
27 too tunitive??, one of the problems with that, practical problems with that is
1 going to be that if as a result of the clinical audit, although the patients won’t
2 be identified it may be that a health care provider comes under the
3 microscope if I can put it that way. Now their going to want to be heard.
4 CHAIR: Well that may be and I don’t think at this point what is an
5 important study should be shied away from just because of the speculative
6 concerns. I thin it should be embarked on.
7 MR HINDLE: Well ma’am of course it's a matter for you to determine.
8 I do stand by the submissions on some of the practical aspects. I accept that
9 I hadn’t looked at it in terms of Section 4D and the subpoena issue in the
10 way that you have. I can only I think say that if that's the committee’s
11 direction, then obviously we’ll do what we can do to facilitate the study.
12 CHAIR: We’ll it's something we wouldn’t give an immediate decision
13 on we’d want to hear others and to consider cases. We do have the Human
14 Rights Commission case – does refer to the earlier cases. To be really sure
15 what we would need to look at is the earlier decisions and the statutory
16 language that was involved in those decisions.
17 MR HINDLE: I haven’t considered the Section 4D, bring it in as
18 evidence proposition. I must admit it didn’t occur to me and it didn’t occur
19 to me I think because it really involves quite – because it is cumbersome and
20 it hadn’t been suggested but we certainly need to look at that and I think also
21 I need to talk to Professor Skegg about the practicalities of all of that as
23 CHAIR: It seems to me that that is the only way of getting over 74A of
24 the Health Act.
25 MR HINDLE: Of course ma’am if I can just say, Professor Skegg, it's
26 not ideal, and in fact it's far less than ideal that the repository of the greatest
27 useful information is the one that it's actually hardest to get at, namely the
1 information on the Screening Register but Professor Skegg did think that he
2 could advance his study without access to that.
3 CHAIR: Well I saw that and it seemed to me you see that we can have a
4 – I can’t see why we couldn’t have a combination of approaches and
5 approaches where if the only way to get at the Screening Register is to have
6 someone from the Screening Register come along and produce the
7 information we’ll do that using the Section 4D power and insofar as we can
8 use the Section 4C power we will do that. We could use a combination.
9 MR HINDLE: Who knows we might be able to persuade the Ministry
10 to pass a regulation that allows us to get around all of this in short order
11 because the Ministry is keen for this study to proceed as we know from the
12 Director General.
13 CHAIR: Well perhaps I’ve taken it as far as I can with you now. Mr
14 Murray I would like to call on you. You will have had an indication of the
15 way in which I’m thinking. Firstly can you tell me this, in terms of doing the
16 correlation between the Cancer Register and the Screening Register is it
17 possible for the Ministry of Health, Health Funding Authority, I’m not sure
18 who it is exactly to actual run such a correlation so that they could quite
19 properly in terms of Section 74A produce a document which is a computer
20 print-out showing the correlation between the two registers because if you
21 could do that legally, if you are willing to cooperate, we could then issue
22 what I will call a subpoena duces tecum to someone from the Ministry,
23 Health Funding Authority to appear as a witness and produce that document
24 which would be a new document that had been specifically created for that
26 MR MURRAY: Yes, could I just have a moment, I’ve heard various
27 versions on that, whether it's possible or not.
1 MS THORPE: Ma’am just while that's being checked I would certainly
2 obtain for you at fairly short order the other cases.
3 CHAIR: I’d appreciate that. Thank you very much Ms Thorpe and I’d
4 also like please to have copies of the specific section that is involved in each
6 MS THORPE: Would you like me to try to do that now while the
7 proceedings continue?
8 CHAIR: Yes please thank you very much.
9 MR HINDLE: One other thought that's occurred to me. In terms of
10 using the subpoena procedure, of course a subpoena is usually whether it's a
11 subpoena ad test adcandum or a subpoena duces tecum is to turn up at a
12 hearing so we’re just also going to have to think about when we’d schedule
13 that hearing for the information to –
14 CHAIR: These are practical problems. One I would want to canvass
15 with everyone whether or not it was considered that for the purposes of
16 receiving evidence of this nature the committee could be treated as sitting if
17 it were just me. If there was a legal problem with that, and we were of a
18 mind to be determined about this, and this involves cooperation from Dr
19 Duggan which I haven't consulted with her about yet, but there is always
20 the possibility of a video link up. I’ve had occasion to cross examine
21 witnesses in Canada through a video link up, so it could be possible for us
22 to sit in circumstances where Dr Duggan is with us by video.
23 MR HINDLE: Yes ma’am I just raise it because it would also need to
24 be fixed at a date I suggest sufficient early to allow the work, what comes in
25 to be analaysed and followed up because it won’t be complete.
26 CHAIR: Firstly I am naive enough to think that provided the legal
27 obstacles are overcome. The matching of the information on the two
1 computers should be a simple matter; it should be a matter of merely
2 pressing a button. Either the two computers can work together to achieve
3 the matching, alternatively if there are two separate printouts someone can
4 sit down and go through it. I could do that quite quickly.
5 MR HINDLE: Yes ma'am, but please don’t forget that Professor Skegg’s
6 study involves going to the clinical notes, and that’s really a key point
8 CHAIR: I’m aware of that. The whole point is he can't go to the clinical
9 notes because he doesn't know the names of the women concerned because
10 the Cancer Registry won't release the names. What we need to do is at the
11 very least get the printout, the correlation of the two Registers. Once we've
12 got that, once we've got the names, then we can find out where the medical
13 records are and then we can look again – we either use the s4(c) power at
14 that stage to let him go in and look at those medical records because we are
15 not going to be blocked by anything like 74A: If we meet resistance we
16 will issue sub-poenas to the doctors, whoever the persons are, to have the
17 medical records produced. Where there is a will there is a way, particularly
18 when you’ve got powers of compulsion.
19 CHAIR: Yes, ma'am.
20 MR MURRAY: Preliminary indications are that that matching can
21 practically be done.
22 CHAIR: You can do it?
23 MR MURRAY: Yes. Don’t ask me to explain the mechanics of that, but it
24 does look as if it can, although I had to add that there will be, then, two
25 categories of women because there will be those are on the Screening
26 Register and those who are on the Cancer Register but not on the Screening
1 CHAIR: Right. What I would like is a document that gave the names of
2 the women in Tairawhiti – when the terms of reference say “Gisborne
3 region”, I interpret that to mean Tairawhiti.
4 MR MURRAY: I wouldn't have a difficulty with that.
5 CHAIR: If we could have the 61 registrations for cervical cancer, the
6 names of those persons. If they could then be related to the Screening
7 Register so we could see how many of them were on the Register and, if so,
8 what the past history was in terms of what their smears were and what
9 laboratory read the smears. And for those women who are not on the
10 screening programme, we really are, under our terms of reference, looking at
11 reporting of cervical smears, so we can actually, I think, look at those
12 women who aren't on the programme and so we should have the names of
13 those women as well. Now if that information could be just printed out in
14 hard copy, give me a name and we will issue a sub-poena duces tecum and
15 that person can appear. I mean, I don’t know how long it will take you to do
16 it because it’s now Wednesday. If it could be done quickly we could have
17 that information by Friday or Saturday, and once we've got that we can then
18 make that evidence available – we will grant suppression orders suppressing
19 any identification. At the moment we will not even make it available to
20 counsel. I think I would want to be heard, but in order to give everyone
21 comfort and security, we could say that names would only be known to the
22 Committee of Inquiry and counsel assisting and any persons the Committee
23 of Inquiry engaged to carry out this exercise. We could then have Professor
24 Skegg look at the material and tells us what more he needs and we could
25 proceed by that way to let him then look at the medical records etc., which
26 we could do using either powers under 4(c) and, if we met resistance,
27 issuing 4(d) there.
1 MR MURRAY: Yes. Could I just have a moment?
2 CHAIR: Yes.
3 MR MURRAY: Madam Chair, I just have to point out that the key people
4 who would do this work urgently are actually here in Gisborne waiting to
5 give evidence.
6 CHAIR: Ms Matcham, no doubt?
7 MR MURRAY: Ms Matcham, yes, and also Mr Fraser from the NZHIS I
8 think is planning to come up here too in case his evidence was required.
9 CHAIR: Could they go back to Wellington and then come back and give
10 evidence, including this nice piece of information?
11 MR MURRAY: Well, I think we have tested Ms Matcham’s patience, but
12 she is a very patient person, and I could see what we can do.
13 CHAIR: Take instructions.
14 MR MURRAY: Yes. Just, I suppose, from there, of course, the Inquiry
15 still has Professor Skegg to come back and say, “Oh, well I do need to go the
16 medical records for 61 women”
17 CHAIR: Yes.
18 MR MURRAY: “therefore, I’d like a formal order of some sort that I can
19 go and drop on the doors of at least 61, and probably many more, clinical
21 CHAIR: Yes.
22 MR MURRAY: So I think my friend, Mr Hindle, is sounding caution, but
23 it may be this is something we have to take a step at a time, as quickly as
24 possible –
25 CHAIR: That’s exactly what I think. I think that we shouldn't just throw
26 our hands up now and say it’s all too difficult. As I see it, there are powers
1 there; they may be clumsy, but they are there and I think, therefore, we
2 ought to try to exercise them.
3 MR MURRAY: Yes. All right, and I think there are some issues about the
4 case law, too, that I haven't closely studied, that I think if we can just have
5 an opportunity to do that.
6 CHAIR: Yes. Ms Thorpe is going to get the decisions, because I, too, I’m
7 really only sounding these ideas out; it may be that when we read the cases
8 that what Crown Law says in para 23 isn't as helpful as it necessarily
9 appears. But I've gone to great detail to set out the cases and one of the
10 passages from the cases, so it does seem to me that the court has been
11 willing to take this attitude that judicial proceedings override these type of
12 statutory provisions.
13 MR MURRAY: Unfortunately, as I quickly read it last night, the last case
14 from which the quotation there is set out, the Human Rights Commission
15 and the Minister of Labour drew a distinction between courts and
16 commissions, and the opinion does seem to be quoting extensively from that
17 decision, which is to the effect that although the BEYNON principle can
18 apply in a court, it would not apply to the Human Rights Commission, and
19 by extrapolation may not, therefore, apply to a Commission of Inquiry. So
20 that issue I have not studied closely, but it’s one we would need to carefully
22 CHAIR: Well, I would like your help on that because the point is that a
23 Commission of Inquiry, particularly one functioning in a sort of quasi-
24 judicial way, is a bit different to the Human Rights Commission in the sense
25 that that body, through its proceedings commissioner, may bring cases
26 before the – I forget the name of the tribunal now, but there is a tribunal that
27 it can take – Complaints Review Tribunal. So, it has a role which is not yet
1 a quasi-judicial role, and the concern about getting access to information
2 may be related to that – I don’t know.
3 MR MURRAY: I think also that, even if the case does say that, this opinion
4 is predicated upon a process that we are now not looking at.
5 CHAIR: Yes.
6 MR MURRAY: the opinion seems to indicate there would be a two-step
7 approach where the Inquiry would get the evidence or information through
8 sort of two different ways, and I would just like a moment to think whether
9 we’re now embarking on a much more direct manner of bringing the
10 evidence directly to the Inquiry and then out to Professor Skegg -
11 CHAIR: Yes.
12 MR MURRAY: - rather than out to Professor Skegg and then in to the
14 CHAIR: Yes. Well I see at p111 of this decision, at line 5, it appears that
15 there was a question being posed for the court under the Declaratory
16 Judgements Act, and the question posed was: “if the Human Rights
17 Commission in the course of investigating or enquiring into a matter relating
18 to a complaint of unlawful discrimination contrary to Part II of the Human
19 Rights Act and in reliance upon s73(1) of that Act requires from an officer
20 or employee of the Department of Labour any information obtained by that
21 officer or employee in the course of such employment (etc), is the employee
22 entitled by virtue of s13 of the Labour Department Act to refuse to
23 communicate or to supply the information” so it does seem as if the Human
24 Rights Commission was actually act there in it's investigating inquiring role
25 in terms of the role that it has to look into matters for the purposes of off and
26 it may result in a complaint being laid by the Proceedings Commissioner
27 which ends up before the complaints review tribunal which is different to
1 the type of decision making hearing that is carried on before a commission
2 of inquiry or committee of inquiry.
3 MR MURRAY: Yes I think there was a key word though that the
4 judgment hinged on and that was the reference to information rather than
5 evidence and it's that point that I just haven’t brought over and looked at
6 closely in relation to the commissions of inquiry act.
7 CHAIR: Well my understanding of your position is you, apart from
8 putting the Crown Law opinion forward you weren’t saying anything more
9 about it. My reading of it is I’m quite happy with it up to paragraph 26 and
10 then I think the logic sort of veers off course and I’m not happy from 27
11 onwards I’m not happy with it in terms of saying yes we can rely on the
12 exception under paragraph f of 74A 5.
13 MR MURRAY: Yes, there’s 2 points I can make about that. One is I
14 think the Crown Law Office has realised there’s a problem with the structure
15 of paragraph 27 and I gather has issued an updated opinion which is very
16 helpful so that point can be looked it. It's just a structural problem with the
17 opinion and I found it quite difficult to follow from that point on. The
18 second point is that, and it may not be relevant now that the inquiry is
19 focusing on taking a different tack, that the Health Funding Authority had
20 already been advised that Section 74A 5F which refers to statistical
21 information was not an exception that the Health Funding Authority could
22 rely on to do the type of audits that it now wants to do anyway for Dr Peter’s
23 work so regardless of Professor Skegg, the Health Funding Authority had
24 already come to the view on legal advice that the reliance on that f exception
25 wouldn't help the Health Funding Authority so it wouldn’t help Professor
1 CHAIR: Yes, no that's what I thought too, I didn’t see a study as being
2 a statistical study. It seems to me if we’re going to do it at all that the way
3 we’re going to have to do it is the way that I’ve suggested and that requires
4 some further consideration which we could perhaps, given that we need to
5 look at the decisions to see whether or not a committee of inquiry can take
6 advantage of the beign?? in principal, it might be better if we resumed this
7 matter say first thing tomorrow.
8 MR MURRAY: Yes I think if we had finished the evidence of Dr Peters
9 I would be happy then to take time out while the Ministry witnesses are
10 being called during the afternoon to see if I can progress this during the
11 afternoon and come back at least with that first step if we can be sure that
12 we can match the information, be satisfied about the powers of the inquiry to
13 at least require that to be brought to the inquiry and then perhaps consider
14 the implications of where we go from there and it may be that my friend Mr
15 Hindle could speak to Professor Skegg again on two points I suppose. One
16 is if he’s given an extended time limit, does that alter his ability to actually
17 do the study and secondly he may be able to give us some practical
18 indication of just how far one has to go with looking for records here
19 because if there are 61 women and just to take an example, if the average
20 woman has 5 health care providers over a time span of 10 years we are into
21 a potentially very big exercise so we may come up against those practical
22 barriers as my friend indicates.
23 CHAIR: Yes we may certainly find that we don’t get to the end but I
24 think at this point we shouldn’t give up, that's my indication but certainly at
25 the moment I want to hear from everyone else first.
1 MR MURRAY: I’m happy to pursue that and that's consistent with my
2 instructions from the Ministry and the Health Funding Authority that if
3 possible it should be done.
4 CHAIR: Thank you very much, does anyone else want to be heard. Mr
6 MR CORKILL: I had prepared some written submissions which for the
7 sake of the record I will hand up. They’ve been overtaken in many respects
8 by this discussion although there are just two or three brief points I would
9 like to make if I may. The first point I’ve made Madam Chair and members
10 of the committee is that although the study relates to what we now
11 understand is approximately 61 cases, we believe that we act for about 16 of
12 them, we do not act for the remainder, we have consistently as I say at
13 paragraph 4 taken the position that we will assist in whatever practical way
14 we could and indeed in May of this year we offered to provide formal
15 consents for those for whom we acted. That is still our position and indeed I
16 can say subject only to funding by the Ministry and I raise that as a serious
17 matter, we would assist in bringing in records and the like were they needed
18 by Professor Skegg. So that's the first point I wish to make. The second
19 point I have made at paragraph 6 is that within the ranks of those whom we
20 represent, some 80 in number, there is probably a dichotomy of views as to
21 whether formal consent is required or not. For that reason therefore I can’t
22 take a formal position one way or the other because there is a range of
23 opinion. Now I don’t propose to take you through the following pages
24 because that's been overtaken, I simply want to draw your attention however
25 to the final section that I have raised which is to do with the Ethics
26 Committee aspect of matters. I’ve referred to the Privacy Commissioners
27 notes at my paragraph 18 where he makes the point that Ethics Committees
1 may consider privacy issues by their considerations may go wider and we
2 then move on to the question of whether Ethics Committee approval is
3 required in any event for this exercise and that is the audit v’s research
4 debate. Now I’m not expressing a view about that but I have just made the
5 final point at paragraph 23 that if it was your view that the Skegg study is
6 indeed research, what we possibility need to know from counsel for the
7 Tairawhiti Health Care Ethics Committee is given that this committee is
8 dealing with the privacy aspects, would the research approval then be given.
9 I see my learned friend has now returned and I have raised this question with
10 her earlier this morning. If we’re going to return to this topic in the next 24
11 hours it may be helpful if that view is known.
12 CHAIR: That's very helpful Mr Corkill. What it had seemed to me
13 because I looked at the national standard for Ethics Committees is that there
14 was a tension between paragraph 3.3 which are those matters not requiring
15 ethical appraisal and that's audit which can be defined as examining practice
16 and outcomes in a particular time and place to see whether they confirm with
17 expectations with a view to informing and improving management rather
18 than adding to general knowledge and that seemed to me entirely what the
19 purpose of the Skeggs study was all about because it's really to inform the
20 committee of inquiry as to whether or not what has happened in the case of
21 the 61 incidence of cancer, whether or not the practice and outcome in
22 relation to those women confirms with expectations and whether or not there
23 could be – it would certainly inform the committee as to whether or not there
24 was any systemic problem with the way in which their medical cases had
25 been handled and in terms of improving management, it would certainly
26 assist the committee of inquiry in terms of any recommendations it would
27 make so I saw the Skeggs study as coming within that definition of audit and
1 then there's the next one, access to personal health information for the
2 purposes of monitoring the quality of care. Well evaluation requires
3 monitoring as a first step because you have to get the information from the
4 monitoring which you then use for the purposes of evaluation. It didn’t
5 seem to me to be original research for the purposes of adding to general
6 knowledge. It would have that consequence but I saw that as a by product of
7 the study and it's essential purpose was to assist the committee in answering
8 it's terms of reference. The only concern I had was when I got to item 3.1
9 which talks about research for innovative treatments involving human
10 participants, and that says “all proposed health and disability research
11 investigations must be submitted for appraisal by an accredited Ethics
12 Committee where the investigation involves human participants. And I
13 wondered about what that meant, because it goes on: “and compares an
14 established procedure, whether therapeutic, non-therapeutic, etc., with other
15 procedures”. That wouldn't apply. But the next one involves “access to
16 personal information for purposes other than direct patient care or internal
17 clinical audit”. And so that, by saying that it involves access to personal
18 information for purposes other than internal clinical audit could involve
19 something of the nature of what we want. But whether this 3.1 applies or
20 not really hinges on whether you see the Skegg study as involving human
22 MR CORKILL: Well, in one view it does, Madam Chair, obviously.
23 CHAIR: One view it does because you are having to look at the records of
25 MR CORKILL: Absolutely.
26 CHAIR: But they are not actively being involved, in the sense you are not
27 engaging with them in discussion or examining them. To what degree
1 human participants involves active involvement by those persons I don’t
2 know. So there seems to me to be a tension between 3.1 and 3.3, but on my
3 reading of 3.3 “matters not requiring ethical appraisal”, I saw the Skegg
4 study for the Committee of Inquiry as coming within that definition.
5 MR CORKILL: Well, Madam Chair, as I say I'm not taking a view on this,
6 but it just to occurs to me from a legal perspective that it’s possible to take
7 the view that whatever 3.1 says, 3.3 overrides it.
8 CHAIR: Yes, that’s right. That’s a good point.
9 MR CORKILL: That may be a view which my learned friend Ms Thorpe
10 could address you on tomorrow, having taken instructions.
11 CHAIR: Yes. The only other point I was going to make is that if we’re
12 going to use the power under s4(d), or even 4(c), it seems to me that those
13 information gathering powers under the Commissions of Inquiry Act don’t
14 require the involvement of an Ethics Committee at all, and the report that
15 Professor Skegg made would be a report back to the Committee of Inquiry.
16 MR CORKILL: Yes, he may, however, take the view from his particular
17 perspective that the process of analysis is akin to research, and that is, I
18 suspect, where the problem comes in.
19 CHAIR: Yes. Well, he may alter his view, we will have to see. If he
20 wants to hold to that view and thinks that he can't do the study without
21 Ethics Committee approval, then we can't force him to do it.
22 MR HINDLE: Ma'am, I should say, I have discussed this with Professor
23 Skegg explicitly, and I don’t want to hold him to what I'm about to tell you,
24 but I think it’s his view that if he were properly authorised to do it within the
25 Commissions of Inquiry Act, he wouldn't personally see the need to deal
26 with Ethics Committees. Now I had better let him have the right to change
27 or modify that answer
1 CHAIR: Yes.
2 MR HINDLE: but I think that’s his position.
3 CHAIR: It’s helpful, anyway, to us, in terms of the powers we have under
4 s4(d) are discretionary, and in terms of exercising the discretion it’s helpful
5 to take into account these matters because obviously if, as we see it, the
6 study is something that doesn't require ethical appraisal we will feel more
7 comfortable about exercising a discretionary power than if we were to
8 consider overriding a requirement which would otherwise exist for Ethics
9 Committee consent.
10 MR HINDLE: Absolutely so.
11 MR CORKILL: Madam Chair there was just one final matter I wanted to
13 CHAIR: Yes.
14 MR CORKILL: And that was your observation a little earlier where you
15 made the point that if health providers were implicated in some way as a
16 result of this study, would there be a need to hear them. We would wish to
17 address you more fully about this in due course, but I can flag our view,
18 myself and my learned friend Mr Grieve, that giving a person an opportunity
19 to be heard in that sense could be perfectly satisfied by providing a draft of
20 any reported comments that might be made to that person and giving that
21 person an opportunity of a response. That is a matter we will develop if
22 needed in due course, but we do want to place on the record now that that is
23 our position.
24 CHAIR: Right, that’s fine.
25 MR CORKILL: In other words, that they don’t need to be brought along to
26 give evidence.
1 CHAIR: yes, well, we can deal with that later. I’m aware that Mr Slane is
2 here and I’m very interested to hear from Mr Slane because, as I've already
3 said in respect of Ethics Committees before exercising the discretionary
4 power under s4(d), if we do have the power to obtain access to information –
5 particularly 74A information – I would want to take into account the privacy
6 principles just in terms of judging how to exercise the discretion. But
7 before I hear from Mr Slane, Mr Rennie do you wish to be heard?
9 MR RENNIE: Ma'am, very briefly. The interests that I represent don’t
10 wish to present detailed submissions on the legal issue. I am asked to
11 convey to you that if it proves possible, in a legal sense to carry out
12 Professor Skegg’s study, then the College, in particular, would state that the
13 proposed study is medically important, should be undertaken and has
14 potentially important outcomes for the health of women. And it may be of
15 assistance if I express that view to you.
16 CHAIR: Thank you.
17 MR RENNIE: Then if I may just add two or three points in relation to
18 matters that have come up in terms of what has been said to you so far.
19 Firstly, you referred to the question – or I think Mr Hindle referred to the
20 question of the issue of sub-poenas and whether it needed to be directed
21 towards sittings of the commission.
22 CHAIR: Yes.
23 MR RENNIE: With respect, you are continuously sitting; it is merely that
24 you are not continuously holding hearings. And in my understanding of the
25 position, there is no difficulty – legal or conceptual – in your issuing sub-
26 poenas directed to the provision of information to you through the period of
1 your sittings (which of course run until December), and I don’t think that
2 that need be an obstacle in that regard.
3 CHAIR: What about receiving the information, because you see, if we
4 issue a sub-poena – as I see it, the area where we most have to use the sub-
5 poena power is getting around s74A of the Health Act, and if Health are able
6 to oblige by getting that information here on Saturday or Friday morning
7 with Ms Matched we will overcome that difficulty, but it does strike me that
8 to receive evidence we have to be sitting. The question therefore is, for a
9 matter such as this, would it be sufficient if I sat alone or do we all need to
10 be present and, if so, would a video link with Dr Duggan suffice?
11 MR RENNIE: Well, ma'am, I don’t think you should take my advice on
12 that, but what I can say, with respect, is that I believe the advice you would
13 be likely to get from Crown Law is to the effect that as an Inquiry you are
14 continuously sitting. If you had a recalcitrant person against whom a sub-
15 poena actually had to be enforced, you might then have to nominate a date
16 and time which was a hearing, but that – I would suggest – is a bridge to be
17 crossed when you come to it, and it would be surprising if, in fact, that
18 proved to be the obstacle. The next point I wish to make, ma'am, is your
19 constitution is actually under s47A of the Health and Disability Services Act,
20 and you have the powers of a Commissioner of Inquiry, and that I
21 respectfully suggest, and I referred to this in opening, is an important – and I
22 think on this occasion – useful distinction. That section talks about you
23 conducting an Inquiry or investigation. And in a way, you are a little
24 broader in your ability to act, and in turn “armed” with Commission of
25 Inquiry powers. And I respectfully suggest that that gives you more
26 flexibility than if you were a pure Commission of Inquiry, constituted under
27 the Commissions of Inquiries Act, and I respectfully draw that to your
1 attention because I think you may find that of assistance. The next point is
2 also drawn out of that section. It would, on my reading of the section, be
3 competent for the Minister actually to constitute Professor Skegg an Inquiry
4 under that section to do his study.
5 CHAIR: Yes.
6 MR RENNIE: And I just call that to attention; it would be a matter for the
7 Ministry, but it might simplify many of the procedural matters – everything
8 from funding through functional organisation to use of powers, and that may
9 prove to be of practical assistance also. But that, of course, is merely a
10 matter I can call to your attention. And lastly ma'am, I just wish to indicate
11 to you one aspect which I suggest may be of material significance and how
12 any process would actually work. There is a practice, which is now I
13 understand recognised as an ethical duty in the medical profession in NZ,
14 and certainly in the pathology field which I represent, that where any
15 disclosure of records arises under compulsion, the pathologist will either
16 through the general practitioner or directly, bring to the patient’s notice the
17 exercise of that power and the purpose of that is of course because the
18 patient has a number of rights not merely of privacy but also of privilege
19 which can only be exercised if it becomes known to the patient that that
20 exercise of power is taking place. Now a lot of the discussion you have
21 heard this morning has proceeded on the assumption I think that it would be
22 sufficient to target the health professionals to obtain the disclosure of
23 information but I have to tell you with respect that the consequence of that,
24 be it with GPs or pathologists would be that that exercise was brought to the
25 attention of the patient and in any final formulation of action that the inquiry
26 might take, it may actually be not only simpler, but also in the end briefer in
1 terms of time to actual direct the inquiry to the patient in the first place
2 rather than through the intervening health professional.
3 CHAIR: Yes well one of the problems that Professor Skegg has
4 encountered from the outset is that he hasn’t been able to identify what is
5 now 61 cases of incidence of cancer registered because he can’t get the
6 names from the register. Once the names are obtained, that job may become
7 easier. The other point that I wanted to raise with Mr Corkill was if the 16
8 patients he represents are happy to give their consent, then their names could
9 be given to Professor Skegg so at least he would know in respect of those 16
10 he had consent and other efforts could be directed towards the remainder of
11 the 61.
12 MR RENNIE: Yes ma’am the point I’m really making is if we
13 hypothesise a theoretical pathology laboratory and it receives a
14 communication from Professor Skegg saying I have authority to inspect the
15 records of the 61 persons named on the attached schedule, do you hold any
16 record for persons of these names, the first step that the laboratory will take
17 is to notify the GPs of those persons whose names are on the list that they
18 have received this notification and they will inquire whether the patient
19 wishes to exercise any right of privacy or privilege in relation to the
20 information which is held. Now if that consequence is going to trigger, and
21 my understanding is that every doctor complying with an ethical obligation
22 will do that automatically, then the inquiry may think that it would be more
23 appropriate for Professor Skegg to approach the women directly in the first
25 CHAIR: Yes well certainly I don’t want to rule that out but it seems to
26 me whatever the ethical requirements are that doctors choose to impose on
27 themselves, the impact of an Order under Section 4D is the person who has
1 control or custody of the information must appear with it, that person can
2 claim privilege where privilege applies.
3 MR RENNIE: I don’t wish for a moment to suggest ma’am that the
4 medical professional would not comply with the order, the medical
5 professional would but at the same time would notify the patient and I notice
6 Mr Hindle’s submissions for example appeared to assume that the patient
7 would not be notified.
8 CHAIR: No I don’t think – thank you for telling me that. Certainly my
9 view was once there was - a position had been reached where patients could
10 be notified, their consent should be obtained where possible .
11 MR RENNIE: My remarks are directed to facilitating the process and I
12 simply wanted you to be aware of how that would work.
13 CHAIR: Thank you very much, I’m very grateful Mr Rennie. Mr Slane
14 you’ve waited patiently in the background, I would very much like to hear
15 from you because although technically the Privacy Act may not apply in this
16 instance, it would be nevertheless very helpful to discuss the privacy
17 principals because I think we should bear them in mind when considering
18 how to exercise the discretion that we have under Section 4D of the
19 Commissioners of Inquiry Act. I’ll ask Madam Registrar to ensure that
20 you’ve got a microphone.
21 MR GRIEVE: Madam Chair just while that's being done, can I raise
22 the question of the form of the subpoena duces tecum because I’ve now got
23 23 hours I see. I’ve been drafting a form and I thought it wise to just run it
24 past you to make sure that it covers what the committee of inquiry want. I’ll
25 just give it to you now, it's very short, I can’t print it out you see but what I
26 was proposing was as soon as I have the indication that it covers the
27 situation I’ll leave and get it printed.
1 CHAIR: Alright I’ll try to hold it all in my mind so read it out. I must
2 say that I have not had to look at this problem myself so don’t treat me as an
3 expert on the form of a subpoena duces tecum. I’ll happily give you orders
4 to do one.
5 MR GRIEVE: I’ve got that from the District Court Rules and so on so
6 there’s no problem with that, just the form says you specify the documents.
7 CHAIR: I’ll ask Dr Duggan to listen too because she’s probably more
8 knowledgeable about laboratory record keeping just so we get the
9 terminology right.
10 MR GRIEVE: It says you are ordered to bring with you and produce
11 etc. the following documents as are relevant to the following issues. 1) the
12 number of cervical smears sent from the Gisborne MedLab laboratory to
13 Hamilton MedLab for reporting during the period 4 March 1996 until 31
14 July 2000 and then 2) the number of cervical smears received from the
15 Gisborne MedLab laboratory during the same period which were reported as
16 containing high grade or other abnormalities and that was it.
17 CHAIR: I think what you better do is to use the words of 4D which says
18 to produce any papers, documents, records or things in your possession
19 because the way you’ve worded it at the moment sounds more like a
20 direction that they must collate this information and if we ask for them to
21 produce the papers, documents, records or things that record the number of
22 cervical whatever it is for the first one and then the second one, then I think
23 that will be more within the language of 4D.
24 MR GRIEVE: Alright I can do that very easily. The other issue is,
25 that's the legal form dealt with, what about the substance. Have I covered
26 that adequately or not.
27 CHAIR: The substance of what we want to hear?
1 MR GRIEVE: Yes.
2 CHAIR: Yes, does it cover what you want?
3 MR GRIEVE: That covers what I want.
4 CHAIR: Yes I just picked up from your submissions on that option to
5 me yesterday so I’m happy with that.
6 PROFESSOR DUGGAN: Can you clarify for me the following. If
7 you are asking for the number of smears between the period 1996-2000 how
8 are you going to determine from that number if MedLab Hamilton requested
9 previous smears for review?
10 MR GRIEVE: Professor as I understand it in that regard we are reliant
11 on the evidence we’ve already heard which will be for the committee to
13 CHAIR: I suppose what your attempting to do is to say over this period
14 of time they received x amount of smears from Gisborne, y of them were
15 abnormal, if they done a look back particularly say 1997/1998 things could
16 have happened sooner in terms of recognising a problem with Dr Bottrill’s
18 MR GRIEVE: Yes.
19 CHAIR: That's fine. Dr Duggan has just reminded me that when Dr
20 Linehan gave evidence we wanted a copy of their manual and I don’t know
21 what you would call it, a sort of process manual.
22 MR GRIEVE: Where they bench manuals?
23 PROFESSOR DUGGAN: It may be a procedural manual?
24 CHAIR: Why don’t we just describe it as any papers, documents,
25 records or things describing the processes carried out in the laboratory for
26 the purposes of cervical smear reading and reporting and that should pick
27 up any quality manual process manuals they have.
1 MR GRIEVE: I can deal with that.
2 CHAIR: And the other point is that there is going to need to be travel
3 expenses sorted out.
4 MR GRIEVE: I understand that Madam Chair.
5 CHAIR: That’s fine. Dr Duggan has just pointed out that the manual that
6 you would want – it may be more than one – would cover the period 1996 to
7 2000. They might have produced one in the meantime, so we would want
8 two manuals then.
9 MR GRIEVE: Thank you Madam Chair.
11 CHAIR XXN WITNESS
12 CHAIR: Right, Mr Slane, I would like to hear from you. I have read your
13 submissions, which you sent. Thank you very much for taking the time to
14 do that.
15 MR SLANE: On the present issue about the process of proceeding with
16 Professor Skegg’s enquiry, as I understand it, he struck two snags which he
17 thought prevented him from doing it. One was s74A of the Health Act, and
18 the other was the Ethics Committee’s requiring of consent. I don’t propose
19 to go into s74A and I've not prepared any submissions on any of this.
20 CHAIR: that’s all right.
21 MR SLANE: But it did seem to me that the difficulty with the Ethics
22 Committee’s consent was something that related to his desire to get 100%
23 participation in his study and the implication, as I understood it, was that if
24 some people refused it might limit –
25 CHAIR: “Bias the study” is the term that epidemiologists use, yes, that’s
26 what I understand his position.
1 MR SLANE: And they limit then the conclusions that he could draw from
3 CHAIR: That's right.
4 MR SLANE: So what it seemed to me was an issue was perhaps that needs
5 to be determined first, whether Professor Skegg can proceed with less than
6 100% participation. But assuming that isn't the case, then I think the privacy
7 considered approach would be to have regard to rule 11 of the Health Code
8 and that would start with the idea that if it has been authorised by the
9 individual concerned, or is being disclosed to the individual concerned, then
10 that’s perfectly all right. So in that sense perhaps the 16 people could
11 collect their own records and produce them to Professor Skegg because they
12 would have an absolute right to get them from the practitioner or they could
13 consent to a third party, Professor Skegg collecting them. The other aspect
14 is what the purpose of the information is being held for. Sadly, I think not a
15 lot of thought is given to that, in relation to medical records generally as to
16 the possibility of using them for research, and thus making that information
17 available to the patient ab initio so that there are no surprises and no
18 problems later.
19 CHAIR: Yes, I must say it seemed to me one way of dealing with the
20 matter for the future would be to treat the – because it’s not just Professor
21 Skegg’s study, we have this problem with Professor Skegg’s study, but
22 equally the Ministry of Health engaged two epidemiologists (Doctors Cox
23 and Richardson) to prepare what they treated as an evaluative study of the
24 Cervical Screening Programme, and that hasn’t proceeded because they
25 can't get access to information. This is the situation where it’s proceeded in
26 part but it’s been held up because of blockages to information, and this is a
27 circumstance where the Ministry of Health, which was responsible for the
1 Cervical Screening Programme, can't hire independent persons to do, what I
2 would in a general sense describe as, an external audit of 3 aspects of the
3 programme that it wishes to have audited. It seemed to me that if, when
4 women had the opportunity to be on or off the programme, it were made
5 clear to them that the programme would entail audits, both internal and
6 external, their consent could be obtained at that point. Now, I've run that
7 past people like Sandra Coney and Mrs Marshall from the Cancer Society;
8 they haven't actually felt that comfortable with that idea. Their attitude is,
9 no, there should be separate consent for an audit, which I have some
10 difficulty with understanding because it seems to me that these days when
11 we accept quality assurance, and auditing is part of most service delivery
12 these days, if you are going to buy into the service part and parcel of the
13 service is the fact that it will be audited from time to time. But I would like
14 to hear your views on that.
15 MR SLANE: Yes, well we've not had occasion to look into it, and I'm a
16 little averse to giving rulings on the run. I think, as far as an audit concept
17 is concerned, one would expect that any hospital and any procedure that its
18 carrying out – any health agency would have some cross-checking, some
19 audits, some quality assurance going on. The Privacy Act is not really
20 averse to the idea of that being contracted to somebody who isn't an
21 employee. So throughout the Act there is a possibility that someone could
22 be engaged for that purpose by the agency concerned. I have read the
23 comments and I agree with a good deal of what Sandra Coney has said, but I
24 think the reservation is about how the matter would be put and it might be
25 difficult, once you’ve got a person there for the first time to have this
26 invasive procedure carried out, that you're suddenly confronting them with a
27 really serious talk and that sort of thing. But it does seem to me that if there
1 was widespread publication of material that indicated what the whole
2 programme was – not just the Register – and that this was put in terms that
3 there may be occasions, for reasons of quality assurance and to see that
4 treatment processes are working, that your own medical records may be – a
5 request may be made to your medical practitioner to make them available. I
6 think that most people would accept that, and particularly if it’s made clear
7 that that access would not be to all the medical records of that person forever
8 but only the records that are pertinent to this particular Inquiry or audit. So
9 I think that is a solution, and I would advocate that from the start for similar
10 screening programmes, mass screening programmes.
11 CHAIR: I would be interested in your view, as Privacy Commissioner –
12 I’m not asking for a ruling at all, but just on the circumstance which has now
13 arisen whereby privacy concerns, and putting aside 74A, that’s a specific
14 piece of legislation, but gaining access to the Cancer Register which has
15 generated a privacy concern and the Skegg study itself has generated a
16 privacy concern about the need to obtain consent to do otherwise, it is said,
17 would be an interference with the autonomy of the individual, is in fact
18 preventing a quality assurance exercise being carried out.
19 MR SLANE: Well, I have two comments: one, the code envisages that if
20 it’s desirable or practicable to approach the person concerned you can do an
21 external quality assurance programme and that doesn't require any ethical
22 approval. The ethical approval is only imposed – not imposed, it is only
23 required where the researcher would have to get it anyway, so all the Code is
24 saying is, “if you have to get that consent” – and I don’t think that would be
25 appropriate, for instance where it’s been ordered under the Commissions of
26 Inquiries powers, to say you also have to have ethical approval – but where
27 you’ve got that situation I believe that it’s contemplated quite clearly that
1 there would need to be an understanding – if I can just go back a step, if
2 there's a quality assurance programme there's no need for an Ethics
3 Committee approval, and I think that’s the important aspect. The second
4 thing is that when I've looked at the Ethics Committees approach and the
5 guidelines, they seemed to be far more concerned with informed consent as a
6 post-Cartwright requirement than privacy which is a much more concept and
7 includes other ideas besides consent. The Privacy Act is much more relaxed
8 in that it doesn’t require informed consent for disclosures of information if
9 you fall within one of the other exceptions and the most important one is that
10 one of purpose.
11 CHAIR: Well in terms of my looking at rule 11 for example where it
12 says there that exceptions where you’ve said at paragraph 18, exceptions to
13 rule 11 restricting disclosure of health information where the health agency
14 believes on reasonable grounds obtaining authorisation of the individual
15 concerned is not reasonable or practicable, 2A for example, disclosure of
16 information directly related to one of the purposes in connection with which
17 the information was obtained and one view I had thought was possible was
18 if quality assurance by doing an external audit of the programme is not a
19 purpose for which the information is being obtained, to me it seems to be a
20 purpose directly related to the purpose for which the information is obtained
21 because the information is obtained for the purpose of the woman being on
22 the screening programme, having her screening history registered, having
23 that accessible and a purpose directly related to that must surely be a
24 checking of whether or not the programme is working effectively for that
26 MR SLANE: I think that's very likely to be the case but we haven’t
27 actually had much judicial interpretation of what is directly related so it's
1 largely been in the opinions that I’ve expressed and particularly the range of
2 different sorts of cases but not of this kind. It has arisen in several occasions
3 when people have made an application to be under Section 54 of the Act to
4 give the authorisation in effect on behalf of the individual concerns and
5 there’s two circumstances in which that can be done. One where there’s a
6 clear benefit to the individual which may well apply in that circumstance and
7 one where the public benefit of the disclosure would substantially exceed
8 the interference with the privacy of the individual and when we’ve look at
9 some of those applications we’ve said to people we think you can do this
10 because what you want to do is directly related to one of the purposes for
11 which you got the information. I thought that one of the difficulties with
12 these consents is sometimes people say you must get the consent of
13 everyone. In fact if they were worried about privacy that would be in some
14 occasions more privacy invasive because the individual may be difficult to
15 trace so you go around disclosing information in order to try and find
16 somebody to ask them something and so balancing the two privacy rights I
17 think is quite important and in the case of Professor Skegg’s approval it may
18 well have been more reasonable to say where that person can be readily
19 traced, but if they can’t be readily traced, then the individual consent
20 wouldn’t be required.
21 CHAIR: Yes that's very helpful because that is one of Professor
22 Skegg’s practical concerns I understand is that people may have moved, they
23 may not be readily traced and the other point is, and sadly in some cases, the
24 woman concerned has died. And I understand there that the Ethics
25 Committee required him to get consent of next of kind and that is something
26 you could help me with because my understanding of the act is an
1 identifiable individual under Section 2 is a natural person who is living is
2 that correct?
3 MR SLANE: Yes it's got to be a living individual except in relation to
4 principal 11 which it can apply to a deceased person and under 11.5, 11.6
5 there is a limit of 20 years so it does apply in those circumstances. I think
6 however you have to take, a committee should take into account that the
7 privacy interests of a deceased person are somewhat difficult particularly if
8 you're weighting the benefits that might come out of a disclosure and that
9 most occasions when that is being considered, in effect is something, the
10 concept is something like the privacy of the family because something is
11 going to be revealed about that person publicly. Now the objection is not the
12 same if that disclosure is quite a limited one to a limited person who has a
13 duty of confidentiality rather than a widespread dissemination of the
15 CHAIR: Yes because I know Professor Skegg was concerned next of
16 kin may be hard to identify and obtain consent from and you see it needs to
17 be emphasised here, my understanding of his study is that in it's ultimate
18 form it's not going to identify cases but just produce conclusions as a result
19 of him having looked at information which for the purpose of forming his
20 conclusions he needs to identify the women and that is another point that
21 struck me in comparing your act actually to section 74A of the Health Act
22 because that makes it impossible to disclose information about an
23 identifiable person to someone such as Professor Skegg in circumstances
24 where it would ultimately be used in a study where the person would not be
25 identified and I noticed, and I may be interpreting this wrongly, but when I
26 look at principal 11 or rule 11 as set out in paragraph 18 it talks about the
27 information is to be used in a form in which the individual concerns is not
1 identified. Now it's not disclosed but to be used and I wondered if that
2 meant it could be disclosed in a way in which the individual concerned is
3 identified but that ultimately the use that was then made of the information
4 would prevent identification.
5 MR SLANE: No I think that what is intended to be stated about
6 where the information is not to be used is that the information is anonymous.
7 CHAIR: Anonymous from the beginning.
8 MR SLANE: From the beginning so the researcher is not getting
9 access to the information about an identifiable individual in a form which
10 they can identify the person and similarly I think I agree with the submission
11 made that this goes beyond statistical purposes. So the main issue is whether
12 it is to be used for research purposes.
13 CHAIR: Yes well see research sort of smacks really of something that
14 is original and being done for the individuals benefit and here we’ve got a
15 study which is not being – Professor Skegg may certainly benefit from being
16 associated with the study but it's not really original research, it's intended to
17 be done so that the committee of inquiry can be assured as to whether or not
18 there is a systemic problem with the national Cervical Screening Programme
19 and we have heard from a number of experts before us and I have found a
20 reference to it in a World Health bulletin information document on cervical
21 screening that one of the best ways of testing the effectiveness of a
22 programme is a clinical audit whereby there is a comparison with
23 information held on the Cancer Register with the Screening Register and
24 then a review of a woman’s past history so if you find cases where a woman
25 has cancer and 5 years before that was receiving normal smears you can then
26 look back at the smears to see whether they were truly normal or whether in
27 fact they were false negatives and had been read wrongly so it's a very
1 effective way of measuring a programmes delivery in terms of whether or
2 not smears are being accurately reported.
3 MR SLANE: I’d make two comments. The first one is that I monitor
4 information matching between Government Depts which was done by
5 computer tapes and it's not nearly as easy as it seems so I think there’s more
6 to it than pressing a button but the numbers are very small here and therefore
7 it's possible to examine them whereas the normal information matching
8 doesn’t have a human hand in it until it produces a match or an apparent
9 match but it does need some human intervention to make sense of the results
10 sometimes particularly if you’ve only got names and names are unreliable or
11 NHI numbers are being entered wrongly or there's a whole host of
12 possibilities there. The other point I’d make is relating to your comments
13 about whether this is a research or quality assurance or audit. If I were
14 considering an application under Section 54 I would certainly regard this
15 much more, and I’d look first to see if it was directly related, but I’d see it
16 much more as being an activity which one might expect to be carried out
17 from time to time rather than one that somebody has thought up as an idea of
18 some useful research that might produce a scientific result of benefit. And I
19 think I ought to expand on that. The consents that I've given in the past I've
20 insisted that the agency concerned has got to be willing to give the
21 information out but sees a barrier of the health code, or the act. I don’t
22 think it’s any good if they don’t want to, granting authorisations that are not
23 going to be put into effect. But it’s worth, in the mix and match that you’ve
24 been discussing of summonses and requirements to produce information, it
25 could be possible, if there are some concerns about people about their
26 responsibility under the Health Information Privacy Code, to approach me
27 for an authorisation.
1 CHAIR: Yes.
2 MR SLANE: But I cannot grant an authorisation if the individual
3 concerned has said no.
4 CHAIR: Thank you very much, that is very helpful. And my
5 understanding of your submission was that your view is that if the
6 Committee of Inquiry wants this information, the Privacy Act doesn't apply
7 to the Committee of Inquiry?
8 MR SLANE: Yes, and I don’t see that – as I've mentioned in my
9 submissions, it’s always a balancing factor, but you’ve got an Inquiry with a
10 duty to get some information to help you make a decision, and there are a
11 number of occasions when statutory provisions override privacy
12 considerations. That is not fatal, in my opinion, because that is the way that
13 we’re structured to deal with it, but we will often invite a government to
14 override the provisions of the Act, but I think that, in doing so, it would be
15 helpful to be fairly strict in the circumstances and conditions that are laid
16 down, and giving a say to the people who are approached would be, I think,
17 to recognise their autonomy.
18 CHAIR: yes.
19 MR SLANE: It’s not necessarily informed consent in all cases, but it is an
20 approach that takes into account the wishes of the individual, which is a
21 privacy approach.
22 CHAIR: Thank you, that is very helpful, because even though the Act may
23 not technically apply, as I said at the beginning, in exercising the discretion
24 under 4(c) and 4(d) to obtain information, the factors that you have outlined
25 certainly I think are worthwhile taking into account.
26 MR SLANE: Yes, I just would emphasise again, from what I've seen in the
27 published documents about Ethics Committees, that I think their concerns
1 arise more directly from informed consent principles in relation to research
2 than they do from a general concept of privacy, and to that extent I disagree
3 with Professor Skegg.
4 CHAIR: Thank you. Ms Thorpe, do you wish to be heard?
6 MS THORPE: I hadn't anticipated being heard at this stage.
7 CHAIR: You don’t have to be if you would like to leave it until tomorrow.
8 MS THORPE: I would like to leave it until tomorrow ma'am, we in fact
9 were not proposing making any comment, but it seems that now we will be
10 certainly required to make at least some comment on the Ethics Committee
11 position and I would need to take further instructions.
12 CHAIR: Very well, thank you. Is there anyone else who wants to be
15 MR MURRAY: If not ma'am, could I just raise a practical matter?
16 CHAIR: yes.
17 MR MURRAY: With Ms Matcham, she's been up here 3 times already,
18 what I would like to do is shortly continue with Dr Peters, hopefully Dr
19 Peters will not be too, and then immediately after that call Ms Matcham so
20 that at least her evidence is given and then if there is work arising out of this
21 discussion she is at least free of her evidence and can concentrate solely on
22 the new issue that’s arisen.
23 CHAIR: No, that’s fine. What I propose to do. Everyone here will have
24 heard the way in which my thoughts are going; you will have had the
25 benefit of hearing from others. What I suggest, I will adjourn matters until
26 tomorrow at 9.30. By that stage I will have had an opportunity, and I hope
27 others will, too, including you too Mr Murray, to have read the case law set
1 out in Human Rights Commissioner and Minister of Labour, which is 1984,
2 2 NZLR at 108, and any other case law that anyone is able to get their hands
3 on down here dealing with a Committee of Inquiry and whether or not it can
4 take advantage of the principle recognised in R v Beynon 1963 NZLR 635 to
5 the effect that a court’s powers to require evidence to be provided override
6 any specific provision in a statute preventing disclosure of information I
7 will adjourn now for 15 minutes, so we will resume at 11.50
10 MID-MORNING ADJOURNMENT 11.35 TO RESUME AT 11.50 AM
2 INQUIRY RESUMES AT 11:58 A.M.
4 MR MURRAY CONFIRMS DISTRIBUTION OF FURTHER DUROSE
5 EXHIBIT [Exhibit JD/HFA/OO12 produced]
7 MR MURRAY ADDRESSES CHAIR
8 MR MURRAY: We got to the stage where I had finished leading a short
9 amount of evidence.
10 CHAIR: Yes.
11 MR MURRAY: The inquiry had asked some questions and I think then
12 there is just a matter now of whether there were any further questions for Dr
13 Peters from counsel and/or the inquiry panel.
14 CHAIR: Does any counsel have any questions, Mr Corkill, anyone else?
16 MR CORKILL XXN WITNESS
17 MR CORKILL: Dr Peters just one matter if I could take you place to tab
18 56 in your latest affidavit.
19 A: Yes.
20 Q: This series of exhibits here as I understand it are the quarterly reports
21 which the Health Funding Authority makes to the Ministry pursuant to it's
22 funding agreement with the Ministry is that correct?
23 A: It's not quite correct the quarterly –
24 Q: Sorry you described them as monthly risk reports at paragraph 8.
25 A: The sector information which is at tab 55 is more or less the quarterly
26 report. We are allowed to submit it 6 weeks after the quarterly report so we
27 are assured the information has all come in for example that the information
1 is complete basically because it's numbers. The monthly risk reports we are
2 all required to document our risks on a monthly basis and my understanding
3 is that if the value of the risk is greater than 80 then it's reported to the
5 Q: Value of 80 on a scale of what? What is the scale?
6 A: I think it goes up to 500 but there's a method by which we calculate
7 the level of the risk.
8 Q: So we assume without necessarily knowing a number that somebody
9 thinks this is more than 80 in terms of potential risk.
10 A: Yes.
11 Q: You don’t know the precise number at this stage?
12 A: Yes because it's got the risk value at the top of the –
13 Q: I see so on the first page of the exhibit, at that stage it was a 326.7
14 risk value.
15 A: Yes. It's probably not very precise, I mean I don’t know how much
16 science there is in it, but –
17 Q: Well what I really – and I see in later documents it reduced to 297.
18 A: Yes I wouldn’t call that really a material difference but it does reduce
20 Q: And if we look towards the end somebody seems to have dome some
21 – I’m looking for argument sake at the second last page in the exhibit which
22 has got a page 10 on it, somebody has done some other arithmetic is that
23 based around this arithmetical calculation –
24 A: Ah yes that's correct, those are the – it looks as though the format has
25 changed. In the main I would write these but while I’ve been otherwise
26 occupied someone else has been doing it on my behalf and it might be that
27 the format has changed recently.
1 Q: Well that was really what I was primarily wanting to ask you was
2 which dept within the Health Funding Authority actually expresses these
3 opinions and it's your dept is it?
4 A: That's correct.
5 Q: But once it goes out to the Ministry it represents the views of the
6 Health Funding Authority?
7 A: Yes unless anybody in the Health Funding Authority wants to change
8 – you know my superiors want to alter it or come to me and suggest it needs
9 to be changed.
10 Q: But what we see here is what has gone out for each of the months
11 indicated to the Ministry.
12 A: That's my understanding yes.
13 Q: Thank you I have no further questions.
15 CHAIR Thank you Mr Corkill, anyone else?
17 MS JANES XXN WITNESS
18 MS JANES: Dr Peters can I just also look at 55 initially. Can you
19 just confirm that under e was that the first time that the statistics had been
20 set out in that particular way which allowed you to make a comparison
21 between the % of women enrolled and therefore be able to correlate that
22 with the incidence for a region?
23 A: No there isn’t any incidence here.
24 Q: No but looking back at a-d it's a global figure of enrollment rather
25 than broken down by region so the question really is is this the first time it
26 was regionally reported?
1 A: That's correct. The Ministry had wanted to come to an agreement
2 with us about providing some more detailed reporting and we presented
3 them with a format and they accepted that and so yes this is the first more
4 detailed reporting.
5 Q: So this was the first time that really there was a geographical
6 enrollment rate that could be contrasted with the incidence rate to indicate
7 whether there may be potential conflicts in the information being derived or
8 issues that should be looked at further?
9 A: That's correct although I have to say that when we went to get
10 incidence data for the 96-98 statistical report from the Cancer Register last
11 year, we couldn’t get anything related to those years so the fact that it's
12 become available – I mean incidence data is clearly much more up to date
13 just over the last few months so we wouldn’t have been able to do a
14 correlation when we did this report.
15 Q: Right because we’ve heard evidence, for instance the Mellor exhibit
16 92, was actually prepared for the commission of inquiry rather than being
18 A: Yes we could only get information up to 95.
19 Q: Right. And just a question on paragraph 6 of your brief of evidence.
20 A: Which one.
21 Q: Sorry I’m confining myself to your latest.
22 A: Yes.
23 Q: Can you just clarify, I may be misreading this paragraph but it seems
24 to indicate that you have recently received approval for a finance manager
25 and an information technology manager and that they would be replacing the
26 current consulting staff.
27 A: Some of them –
1 Q: That was the question I was going to say how could two full time
2 appointees replace 6.5 full time consultants.
3 A: No we’ve got a consultant IM manager who would be replaced as a
4 permanent appointment and there’s been a general finance manager for the
5 public health operating group who recently left the Health Funding
6 Authority and at the moment I have a consultant financial analyst whose
7 available to me two days a week but if we are to assume that responsibility
8 for funding both the screening programmes nationally, then I would need a
9 more or less full time financial manager to work with the contracting team to
10 ensure all the contracts were right.
11 Q: So your basically only swapping consultants in those two positions
12 for full time permanent replacements.
13 A: Correct.
14 Q: I just thought your life was going to get a lot harder rather than easier.
15 Covering just briefly what was gone through yesterday with the panel, at tab
16 40 of your supplementary exhibits, I think you indicated in your evidence
17 yesterday that to the best of your knowledge it was likely that the only
18 significant factor under discussion in the laboratory standards was the
19 number of smears, you indicated that that was probably the only one that
20 was still up in the air.
21 A: I do think that's the major issue. Another issue that – there are some
22 other issues for example providing if on a slide review a report changes,
23 whether that updated report is provided to the Register. There are some
24 other issues that laboratories have raised with us but I do still stand by the
25 fact that I think the volumes will be the most contentious issue to resolve.
26 Q: And so if they’re essentially a consensus document apart from the
27 volume of smears at the moment, is it the case that if there was sufficient
1 staff resources available, because you also indicated that you can’t complete
2 the drafting of these documents and get them implemented and monitor at
3 the same time, so would it be the case if there was sufficient resources, it
4 would be possible to begin monitoring against the non-contentious aspects
5 of the draft standards?
6 A: I certainly wasn’t meaning it imply that I absolutely don’t have
7 enough staff, but with the resources that I have I think at the moment we are
8 concentrating – well, I know we are concentrating on finishing the
9 consultation process, finalising the standards and then commencing an
10 implementation process with providers. We do know we need to develop a
11 process for monitoring compliance with these standards, and whether that’s
12 a process of spot audit or regular audit we just haven't got to yet. But, I
13 mean overall, I think staff resources are somewhat of an issue, yes.
14 Q: And just going down that track slightly further, in the agreement which
15 is at Ms Mellor’s exhibits 89 I believe – the agreement we looked at
16 yesterday – that came into force on 14 March?
17 A: Yes.
18 Q: Is it the intention of the Health Funding Authority, or the Ministry as it
19 will be then, to complete monitoring say on 14 march 2001 when these will
20 have been in force for a year or will you not be in a position to do that
21 because they actually won't be implemented until almost the end of this
23 A: well if I think about the breast screening programme, which is the only
24 other sort of experience I have in this, providers developed quality plans
25 themselves, which was to indicate to us how they would meet the quality
26 standards, and I think, to be fair, it will take providers – I really have no
27 assessment at the moment of how big a job that will be for providers and I
1 suspect it will vary around the country as to how big a job full
2 implementation will be. Also, developing an audit plan, as I think we
3 discussed before, is quite a complicated business. When I say complicated,
4 it requires some work to get it right, so I think it would be unrealistic to
5 think we would have audited all the providers by March next year.
6 Q: is it any concern to you that a contract we entered into on 14 March this
7 year that indicated that laboratories were bound by these standards but you
8 won't be in a position to monitor against those standards for at least a year
9 after that agreement was entered into, or perhaps even longer?
10 A: Well, it is of concern, but we can only do what we can actually
11 physically do and it just simply wouldn't be possible for us to finalise the
12 standards, organise the implementation, be developing an audit plan, at the
13 same time monitor all the laboratories against these standards, implement the
14 quantitative monitoring of the Cervical Screening Programme, develop new
15 resources for the screening programme so women have better information
16 and all the ongoing operational things we have to do of servicing the
17 advisory group, managing transition issues and managing the breast
18 screening programme as well. It would absolutely not be possible to do all
19 those things.
20 Q: It’s certainly not a criticism of the efforts, but the concern that perhaps
21 there is for the Inquiry is that, I mean there's been a tremendous amount of
22 excellent work carried out in a short space of time, the reality that there may
23 well be a 3 year period before monitoring and the whole shape of the
24 programme has always been that because of health restructuring and changes
25 of staff that you implement something and then it changes and the
26 monitoring and evaluation always somehow gets shunted out into the future
1 CHAIR: Sorry, I just want to pause there because you're saying a number
2 of propositions which the witness is acknowledging by nodding her head,
3 but it’s not being recorded, and the way the whole thing is going to end up
4 on the transcript is a series of statements by you to which there won't be a
5 clear answer, which could be interpreted as acknowledging everyone of
6 them in the transcript. So perhaps we will just note for now, for the purpose
7 of the transcript, since you started this question, I have observed Dr Peters
8 nodding her head in acknowledgement. Dr Peters, are you happy if I have
9 that noted in the transcript?
10 A: I can't now remember what all the propositions – I think I was sort of
11 nodding with concern that those things were being said.
12 Q: Well, perhaps the proposition should be repeated one at a time to see
13 whether the witness agrees with the propositions and then build on that.
15 MS JANES: Okay. I will see if I can remember the multiple propositions
16 myself. I think the first proposition, Dr Peters, would you agree that there is
17 a concern that because of the health restructuring that has occurred within
18 the decade of the 1990s that there have been attempts to implement
19 monitoring and evaluation, which because of health changes have meant that
20 they have not been fully implemented?
21 A: I'm would be concerned that restructuring led to instability and a failure
22 to implement what we have commenced. I really believe what we need at
23 the moment is stability, and while I know there have been calls for setting up
24 of other agencies, I think one of the issues for NZ is that we haven't
25 developed the expertise in the national office, and I think we are starting to
26 do that, and I think that we need to have that stability – at least in the
27 medium term.
1 Q: Probably the best way of developing it is to go backwards. In your
2 exhibit 56 you indicate at p1, and it’s repeated several times through that –
3 A: Yes, you only update it if you feel you need to.
4 Q: At the second para on p1: “Since the programme was established in
5 1990 no national quality standards have been developed for programme
6 providers. There has been little monitoring or evaluation and no strategic
7 review of the programme’s direction.” Do you agree with that statement?
8 A: Probably in retrospect I think that’s a little harsh. I wasn’t aware of the
9 laboratory quality standards that had been developed in 91 and 95, and I
10 wasn’t aware of a lot of the evaluation reports which, while I wouldn't call
11 them complete programme evaluations, obviously evaluated some aspects of
12 the programme. But I do agree that, in general, there didn't seem to have
13 been a coherent approach to those things.
14 Q: Just to clarify, if we can take it a step at a time. What are you referring
15 to when you say the 1991 laboratory standards?
16 A: Sorry, those cytology standards that seem to have been developed by
17 CALC that TELARC adopted.
18 Q: But to your understanding, they were not adopted by the Ministry of
19 Health were they, they were just TELARC?
20 A: Yes, that is correct.
21 Q: That decided to accredit against them?
22 A: Yes, they weren't mandated in a contractual sense, no.
23 Q: so only laboratories that were actually accredited would have been
24 monitored against those by TELARC and not by the Ministry of Health?
25 A: That’s correct.
1 CHAIR: And laboratories in 1991 weren't required to be TELARC
2 accredited for the purposes of the programme, were they?
3 A: No.
4 Q: Just so we can be sure of what the standards are, because it varies a lot
5 as to what they are, could we look at these standards of 91, just so I know
6 where they are?
7 MS JANES: Boyd 22 I think.
8 CHAIR: My understanding of this document Boyd volume 5, 22, is it’s
9 called the Cytology Advisory Liaison Committee Recommendations?
10 A: That’s true.
11 MS JANES: That’s correct. And ma'am, without sort of leading evidence
12 from the bar, the evidence has been that they were recommendations from
13 the CALC that were then written to TELARC and TELARC made the
14 decision to begin auditing against them but they were never formally
15 adopted by anybody except TELARC.
17 CHAIR CONTINUES XXN OF WITNESS
18 CHAIR: That's what I understood and in any even Dr Peters when you
19 look at them they refer to checking of abnormal smears, re-screening of
20 negative smears, average number of slides read by screeners in terms of
21 setting a maximum, external quality control and off site home screening.
22 What comment do you have to make on how far these recommendations go
23 in terms of laboratory performance.
24 A: Well there a start but they’re not comprehensive.
25 Q: I note that although in 1991 these recommendations refer to off site
26 home screening in a way in which the committee recommends there be a
27 general phase out of home screening was full implementation from Jan 93, I
1 note from the DuRose study that one laboratory still seemed to be doing
2 home screening. What comment do you make on that?
3 A: Well if the laboratory was accredited it didn’t seem to have been
5 Q: Right so that's the 91 –
7 MS JANES ADDRESSES CHAIR & CONTINUES XXN OF WITNESS
8 MS JANES: Madam Chair can I just confirm that Dr Peter’s
9 understanding was as I explained it I didn’t get a formal acknowledgement
10 for the record. Do you agree with the understanding that I indicated in
11 relation to – that it was recommendations from the CALC committee
12 transmitted or relayed to TELARC who then independently decided to start
13 monitoring those laboratories that were then accredited against those
14 standards. Does that comprehend with your understanding. In other words
15 it was never formally adopted except by TELARC?
16 A: I haven’t really been very clear about the chain of events. Whether
17 the Ministry wouldn’t have had any, been able to enforce these on TELARC
18 so I guess they would have had to accept them voluntarily so yes I accept
20 Q: Thank you. Then if I can take you to the same volume, tab 25, are
21 these the 1995 standards that you’ve subsequently become aware of that you
22 mentioned earlier?
23 A: Yes.
24 Q: And again just for the record can you confirm that again these were
25 prepared by the CSLAC committee this time?
26 A: Yes.
27 Q: And the next page say that they are standards for TELARC.
1 A: Yes.
2 Q: So to the best of your understanding they would fall into the same
3 category as the 91 standards.
4 A: Correct.
5 Q: And again following Madam Chair’s line of questioning previously,
6 if you can quickly look through the standards.
7 A: Well they are more explicit. They don’t – they are more detailed but I
8 don’t think they’ve got anything about minimum volumes or minimum
9 volumes for cytoscreeners in them.
11 CHAIR INTERJECTS AND XXN WITNESS
12 CHAIR: How do they compare in your view with the draft standards –
13 yes I’ll refer to them as draft standards in your exhibit 42 which set out
15 A: They’re not as detailed.
17 MS JANES CONTINUES XXN OF WITNESS
18 MS JANES: So you’re understanding again with these would that it
19 would only be laboratories delivering services to the national Cervical
20 Screening Programme that were accredited that these would actually pertain
22 A: Yes presuming TELARC did adopt them.
24 MR MURRAY ADDRESSES CHAIR
25 MR MURRAY: Madam Chair just so we can try and get a bit of clarity
26 here on this point, I did actually ask Mr Walker whether TELARC was
27 applying those 95 revised document and he didn’t seem to be very clear
1 about that and that was just left and I don’t think it's been covered in the
2 evidence anywhere else and I’m not sure whether my friend Ms Hannah has
3 had a chance to speak with Mr Walker subsequently but I think it would be
4 one of those issues that is a loose end that the evidence could tidy up if
5 possible before we finish.
6 CHAIR: We might need to get an affidavit from Mr Walker just saying
7 what standards they apply.
8 MR MURRAY: Yes because he’s really the only one as I understand it
9 that would know what TELARC was doing with that document.
10 CHAIR: What about the national quality standards of 97, I still haven’t
11 come to grips with those because my understanding of them is that they are
12 the draft standards to the Mules exhibit but I might be wrong there.
13 MR MURRAY: Well two points and Ms Janes can probably help too.
14 Two things have happened actually, the Health Funding Authority itself has
15 now of course contracted them in that and we had a discussion about that
17 CHAIR: I was only focussing on the cytology standards I haven’t got to
18 deal with the others yet.
19 MR MURRAY: Sorry.
20 CHAIR: That's a joy that still awaits us.
21 MR MURRAY: We’ll put that one to one side and what we have done is
22 contract the chapter 5 document but I think at that point perhaps Ms Janes
23 better pick it up.
24 CHAIR: Yes so your understanding anyway is that the Health Funding
25 Authority has, you would say, by the variation in the contract at Mellor
26 exhibit 89, put into place the national quality standards for laboratories of 97
27 plus the draft cytology standards for the year 2000.
1 MR MURRAY: Yes and carrying one step forward perhaps, the question
2 is what will the role of TELARC be with that 2000 document. Dr Peters I
3 don’t think her work has got that far but she could confirm whether I’m right
4 about that or not.
5 CHAIR: Thank you Mr Murray.
7 MS JANES ADDRESSES CHAIR
8 MS JANES: Ma’am we were actually going there because in trying
9 to seek clarity I’m probably just about gong to muddy the waters some more.
10 CHAIR: That's alright.
11 MS JANES: But just on those Mr Murray is correct that the evidence
12 from Mr Walker was that TELARC had adopted the 1991 standards but he
13 was uncertain –
14 CHAIR: 91 or 95.
15 MS JANES: Sorry the 91.
16 CHAIR: That's the recommendations.
17 MS JANES: Exhibit 20 to the recommendations.
18 CHAIR: And 22.
19 MS JANES: They were auditing against those but he wasn’t certain
20 what had happened with the 95 so I will seek confirmation and get an
21 affidavit for him as to the status of those.
22 CHAIR: There’s not much to audit against in these 91
24 MS JANES: No it was an addition to their standards for medical
25 laboratories generally so this was just an addition for cytology depts in
1 CHAIR: And so you don’t know what the status of this Boyd 25 exhibit
3 MS JANES: No Mr Walker wasn’t certain as to whether they had –
4 the assessors looking at those.
5 CHAIR: Dr Duggan says she has a note on her exhibit saying
6 informally accepted by TELARC but she doesn’t know who said that. Ms
7 Sholtens can you help?
9 MS SHOLTENS REPLIES
10 MS SHOLTENS: Can I assist, I think it's right that Mr Walker’s
11 clarification would be useful. Perhaps Dr Duggan’s remark was based on
12 the minutes from CALC which showed that from 94 a TELARC
13 representative who was on the committee – sorry there was a TELARC
14 representative on the committee and a TELARC person who came along to
15 the committee seeking new standards and they were developed over a 14
16 month period resulting in these ones.
17 CHAIR: Yes you’re right that fits in with the note I made because I
18 wanted to ask Professor Teague from CALC’s point of view when were
19 standards developed and I’d made a note 1995 which must be a reference to
20 the informal adoption of these standards perhaps. Yes well we’ll have to
21 find out from Mr Walker.
23 MS JANES CONTINUES XXN OF WITNESS
24 MS JANES: So that probably takes us as far as we can on the 1995
25 documents. I was then going to go to the fact that the national quality
26 standards which I am assuming are the 6 standards that were developed in
27 1997, are you able to confirm that's contained in the agreement.
2 CHAIR INTERJECTS AND XXN WITNESS
3 CHAIR: Could we just stop there and go to them because my recall of
4 when Ms Sax gave her evidence was that Ms Kay pointed out that there was
5 a difference between her draft of these draft standards and the draft of Mr
6 Mules exhibits, and the documents, as I've seen them, are always described
7 as “draft”.
8 MS JANES: Madam Chair, again if I can give evidence from the bar, that’s
9 exactly why I'm going to muddy the water because it is a difficult situation
10 in that we have the draft standards in Ms Sax’s exhibits, the standards in Mr
11 Mules, then also in Mr Walker’s, which he believed to be the final draft, but
12 then in evidence he indicated that because the Health Funding Authority and
13 the Ministry had not done anything with them, they had made some minor
14 variations and had now adopted them formally – TELARC had – and they
15 were now monitoring against them because they couldn't wait any longer for
16 the Health Funding Authority or the Ministry. I believe he said there were
17 some minor amendments. So what TELARC may well be monitoring
18 against may well not be the document that is required by contract.
19 CHAIR: When Mr Walker does his affidavit, explaining what happened in
20 respect of the 1995 standards, could he also annex as an exhibit the actual
21 standards TELARC is now using to monitor laboratories that are accredited
22 for cytology?
23 MS JANES: Yes, he can, ma'am. But I think if we can clarify from Dr
24 Peters what her understanding of what is contractually required so that we
25 will know what that document is.
26 CHAIR: Yes, that’s a good idea.
1 A: I don’t think I could comment on that because I've had nothing to do
2 with the development of the generic standards. And I’m not familiar with
3 the document control processes that the RHA or the Personal Health team
4 use. I’m aware that document control and making sure everybody’s
5 working from the same document is a big issue, and it’s certainly something
6 that I want to sort out for my unit over the next little while.
7 MS JANES: So, are you not in a position to assist the Inquiry as to the
8 exact draft version that is contained in the agreement with the laboratories?
9 A: No.
11 CHAIR: Perhaps if I could ask Mr Murray. Mr Murray, can you help.
12 This variation which the Health Funding Authority signed on 7 March 2000,
13 what national quality standards was it referring to, because I've now got 3
14 versions of these and I don’t think any of them are actually called the
15 national quality standards for medical laboratories 1997.
16 MR MURRAY: Yes, I'm grateful to my friend for muddying the waters
17 because I know they were muddy and I was struggling to think how we were
18 going to untangle this in a tidy way. But I can say that I've been aware of
19 this issue and I've been struggling to think of a tidy way of just putting it
20 before the Inquiry. But if I can say, at least from the bar, that as a response
21 to my enquiries about it, the document that the Health Funding Authority,
22 the version of the document the Health Funding Authority used to complete
23 that March 2000 variation is headed up “Draft National Quality and Service
24 Standards for Medical Testing laboratories”, which is the same title that I
25 think you’ll see right through – whichever version you are talking about, but
26 it’s a version of that document dated 10 June 1997.
1 CHAIR: Why didn't you describe it as a draft, considering you’ve referred
2 to draft at para 8a, why not draft in para b, it’s misleading?
3 MR MURRAY: Yes, and I think this is what is still untidy, and what I
4 suggest, just so that we can get some clarity on this, if my friend can get an
5 affidavit from TELARC about the document that they have finalised, I will
6 get a document from the Health Funding Authority – an affidavit which
7 confirms the document they have finalised. It will be great if it’s the same
8 document, but if it’s not, at least we all know what two documents have
9 been used.
10 CHAIR: Exactly. We will then, at least, have the documents and we will
11 know for sure what we’re talking about. Is there any hope of you finding a
12 draft cytology standards 2000 document?
13 MR MURRAY: Actually, I think that is the terminology that’s probably
14 been used to refer to chapter 5 of the manual, so I don’t think there's much
15 hope that –
16 CHAIR: You don’t think there is?
17 MR MURRAY: No, but I will make enquiries about that.
18 CHAIR: It just seems a very specific description, and it seems to me that in
19 a legal document such as this, if you were wanting just to refer to chapter 5
20 of exhibit 40, that you would do so in some way.
21 MR MURRAY: Yes. I think I’ll get that point covered in this affidavit
22 and I’ll get the National Quality and Service Standards for Medical Testing
23 laboratories document annexed to the affidavit, the one that has been
24 contracted in the variation, and I’ll also get the affidavit just to indicate what
25 that reference to the other standard document is intended to be and annex it
26 if it’s something that we don’t know about, but otherwise just confirm what
27 it is.
1 CHAIR: yes, because so far all I have is what Dr Peters has said, and given
2 – this is no disrespect to her – that she has been unsure about other aspects
3 of contracting, and given that contracts would be dealt with by the legal
4 team and some other team within the Health Funding Authority, although the
5 general understanding may be that the substance of chapter 5, exhibit 40 is
6 what is being referred to, it would be nice to know how the actual linkage
7 was made.
8 MR MURRAY: Yes. I mean, I think it’s important, because we will be
9 making submissions about this, so I would like to tidy it up for my own
10 purposes so I will do that.
11 CHAIR: Okay.
13 MS JANES: I probably can't take that any further with you, there's no point
14 showing you an exhibit if you haven't seen that document. One final
15 question Dr Peters, it’s actually a series of questions. You’ve indicated that
16 there is this debate about the minimum number of smears and it appears
17 from the exhibits in your supplementary brief, the first supplementary brief,
18 that it appeared to be ranging around the 12,000 but there was debate as to
19 whether it should be slightly lower or higher.
20 A: Yes.
21 Q: And I’m not sure if you are aware of Dr Cox’s evidence which also
22 indicated that he thought 20,000 would be more appropriate; do you recall
24 A: Yes, I do recall that he at least thought it should be higher.
25 Q: And that there has been recommendations from the advisory committee
26 that 10,000 would be an appropriate minimum, are you aware of that?
1 A: I am aware that an expert group met in 1998 and this was one of the
2 issues they covered. To my knowledge it has not been raised by the current
3 advisory group.
4 Q: I stand corrected, it was the expert group, thank you. Based on that,
5 would it be correct to say that 10,000 would be the minimum that would set
6 even if there is a level of debate?
7 A: I think it would be, but 10,000 as a minimum would concern me
8 because I don’t feel there's any then margin for annual fluctuations, and I
9 think it’s laid out in that paper. I mean, ideally, I think it should be higher,
10 but I'm searching for a solution which – I think it’s important that we have at
11 least one publicly owned and funded laboratory undertaking cytology in NZ,
12 and obviously that would be the National Women's Hospital. And so it’s
13 concerned me not to be establishing a minimum volume which would enable
14 them to continue what they're doing because they do so much in training and
15 they are a centre of excellence in NZ. So there's some practical
16 considerations around the figure, but I think ideally, as Dr Cox said, if we
17 were starting de novo and we were actually actively planning how things
18 would be organised, that would be higher.
19 Q: If you were planning de novo, would you consider centralising it to say
20 4 laboratories nationally?
21 A: Yes. Well, it may not be 4, but certainly a much smaller number. I
22 mean, first of all, from our perspective, there are practical considerations
23 with that in terms of auditing a smaller number of laboratories, you don’t
24 need such a huge workforce. Whereas what we are confronting now is
25 numerous laboratories providing services to the programme who will all
26 need – and that’s why I mentioned spot audit because if you do it in an
1 unpredictable way I guess people could be expecting it all the time, knowing
2 that we wouldn't be able to cover everybody in a timely way.
3 Q: The reason I've asked this question is because understanding that you
4 don’t have the resources to monitor against the draft standards immediately,
5 would it not be one thing that the Health Funding Authority could do given
6 that if you take the cut off point of 10,000 which is maybe slightly too low
7 but at least it is a number, could a letter not be sent immediately to
8 laboratories who are operating under that minimum acceptable level and in
9 that way rationalise the laboratories that provide services to the screening
10 programme immediately subject of course to National Women’s which may
11 be an exception to that?
12 A: I think I would need to look at the contracts because there may be
13 some legal requirement, in fact I’m almost certain there would be that if you
14 are going to remove a service or change the nature of a service that you have
15 to give notice of a period of months I would think.
16 Q: But is that something that could be considered in order to rationalise
17 the programme?
18 A: Definitely.
19 Q: Thank you I have no further questions.
21 PROFESSOR DUGGAN XXN WITNESS
22 PROFESSOR DUGGAN: Dr Peters I have one question in this
23 regard. Why does the Health Funding Authority have to come up with the
24 solution for the laboratories in terms of the provisions of services?
25 A: Well what –
1 Q: Or why does the screening programme have to come up with a
2 solution. The screening programme it appears on your documents knows
3 what it wants. Why are you working so hard at getting a solution?
4 A: Well nobody’s coming to us with a solution, nobody else.
5 Q: Have you asked for a solution?
6 A: You mean have we gone to pathologists and said how are we going to
7 deal with this?
8 Q: Well you have a draft policy and national standards document and in
9 your view, and correct me if I’m wrong, this is how you and your group
10 wanted to deliver the programme.
11 A: Yes.
12 Q: My question to you is why have the pathology group not responded to
13 your needs with a solution that gives you what you need?
14 A: I don’t know but I could speculate. I mean it would –
16 CHAIR INTERJECTS AND XXN WITNESS
17 CHAIR: Sorry you can’t speculate. You’ve been asked to say what is
18 the pathology – why aren’t pathologists giving you the answer?
19 A: I don’t know, I know that the College – I don’t know why they
20 haven’t come to us with a solution but for example I know that there are
21 views among pathologists that there is no evidence for a minimum volume
22 and therefore it's all arbitrary and they will participate in our consultation
23 process but they are not necessarily going to support the outcome of it. So
24 we have a legal requirement to consult if we are going to significantly alter a
25 service and we are undertaking that. Now ultimately if we – and I mean we
26 do have a legal obligation to hear people’s views and actually consult –
1 actively consult it's not just a façade – but no groups are coming to us with a
3 Q: Is there resistance at all or do you think that pathologists are just
4 begrudging accepting the standards that you want to impose or is there a
5 willingness to accept them or does it vary?
6 A: I think there's a general willingness, it does vary and because I’m a
7 little bit removed from the process being up here – but certainly I know that
8 the hospital laboratories are concerned and have expressed that concern.
9 Q: Does it seem to you, we’ve heard that the hospital laboratories need
10 to do cytology in order to be able to offer training facilities to registrars, it
11 had seemed to me that if a hospital was processing a very small amount of
12 smears, for example Gisborne laboratory had been processing 2,000 when
13 Dr Lapham decided that that wasn’t sufficient to maintain her competency,
14 that any hospital that wanted to continue with cytology if it was just reading
15 a small amount of smears would not actually be in a very good position to
16 offer teaching facilities and good teaching anyway?
17 A: Well that's a concern of ours as well and as I speak there’s a meeting
18 with the hospital laboratories and that's one of the issues that my colleagues
19 would be discussing with them today.
20 Q: Is the sort of power of persuasion that the hospital laboratories have
21 sufficient if they maintained a position that they should do cytology even if
22 they don’t meet the minimum standards such that you would have to yield to
23 that position?
24 A: Well I would very much hope not. I mean I’ve never been involved
25 in a situation like this before but I’m hoping that we can work through the
26 issues with them an perhaps come up with some creative solutions.
1 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
2 PROFESSOR DUGGAN: Clearly there’s – because I don’t know
3 everything about your New Zealand situation – there’s something I don’t
4 quite understand in this and maybe you can indulge me with some
5 information. Is the Health Funding Authority required to contract with all
6 laboratories for the provision of ?? for the National Screening Programme?
7 A: No I wouldn’t have thought so.
8 Q: But do you know so?
9 A: I think I can say that fairly – I think –
11 CHAIR INTERJECTS AND XXN WITNESS
12 CHAIR: That's something we can ask Mr Murray.
14 WITNESS REPLIES
15 A: I think because it's been part of generic contracts it's just been part of
16 the deal of the contract but when the funding is transferred to my team and
17 we did a specific contract for the programme then I don’t see that we would
18 be compelled to contract with every potential provider in the country. I
19 mean we don’t do that with breast screening so I don’t see why we would do
20 it with cervical screening.
22 MR MURRAY REPLIES
23 MR MURRAY: Legally I think the answer is no we’re not obligated to
24 contract, it could go out to tender for example –
26 WITNESS REPLIES
1 A: It's historical, an historical fact but I think when you then want to
2 materially change the way you contact for the service, there are some legal
3 obligations of processes you have to go through.
5 PROFESSOR DUGGAN CONTINUES XXN OF WITNESS
6 PROFESSOR DUGGAN: And this is what you’re involved in right
8 A: Yes.
10 CHAIR ADDRESSES MR MURRAY
11 CHAIR: Can I just interrupt, Mr Murray could you help me. Is the
12 process because a Health Funding Authority is a public body that if it was
13 suddenly going to refuse to send it's work to a particular laboratory or
14 change it's method of contracting by suddenly saying we will only go to 5
15 laboratories that there would need to be a period of consultation because to
16 do so without hearing from the laboratories who in the past have received
17 the Health Funding Authority’s work would breach a legitimate expectation?
18 MR MURRAY: Exactly, I should say that of course we are coming to
19 the end of the Health & Disability Services Act so my answers now are
20 based upon that statute and this has been a significant area of litigation in the
21 health sector with rest homes for example, there’s judgments I can refer the
22 panel to probably in submissions that would be an occasion to do so but
23 exactly, it's a mix of public law consultation under statute and when those
24 obligations are fulfilled then the Health Funding Authority can execute
25 contractual agreements.
26 CHAIR: But presumably too and I think I’ve read decisions on this
27 point, any powers that did exercise to contract would have to be exercised
1 reasonably. There is a decision involving the Northland Regional Health
2 Authority where they cancelled an electricity, well some sort of contract I
3 don’t know what and they ended up being I think judicially reviewed
4 because – on grounds of unreasonableness something like that.
5 MR MURRAY: I don’t think that's actually the big issue that arises in
6 the health sector. The case law is very much along the lines of changing the
7 principles of contracting, for example, if contracts had been negotiated with
8 everyone and then the funder decides “No, there are too many providers, the
9 quality’s not good enough, we’re going to go out to tender and we’re going
10 to set quality and price parameters and after that we are only going to
11 contract with the successful bidders and that that means there will be a
12 limited number of providers in a particular area”, then before that is done
13 there has to be consultation under s34 of the Health and Disability Services
14 Act. That very situation is the facts of the case that arose in Auckland
15 straight after the Health and Disability Services Act was set up with the
16 resthomes. So the principles are quite clear. Unfortunately were now
17 going to move into a whole new statute so what the law is there, I don’t
19 CHAIR: Thank you.
21 MR KIRTON: Madam Chair, if I could be a little helpful in this regard at
22 well, there is the issue of a framework – the so-called quality framework – in
23 which accessibility is referred to, and in there, I think from memory, the
24 range of services need to be provided within 90 minutes of the centre of
25 service delivery, and that, from memory, laboratories main fall into that
26 category and therefore the framework would need to be changed to
27 accommodate that.
1 CHAIR: Thank you very much Mr Kirton. I recall reading something
2 about that, and I’m not sure what I concluded about laboratories. Thank
5 PROFESSOR DUGGAN: So you are required to consult if you are going to
6 change the service?
7 A: Yes.
8 Q: How long do you consult; is there a finite time on the period of
10 A: I can't tell you exactly.
12 CHAIR: Is it in the Act?
13 MR MURRAY: No, not a time limit, it’s the Wellington Airport
14 consultation law unfortunately, and so much legal advice has to be given on
15 all of these because consultation can be quite contentious, depending upon
16 the particular commercial group you're dealing with. You can assume the
17 laboratory provider group consultation is contentious.
19 PROFESSOR DUGGAN: did I get a period of time out of that?
20 CHAIR: No, there isn't one. It’s what lawyers say it will be.
21 PROFESSOR DUGGAN: I’m going to resist making a comment. Could
22 we move to your exhibits, p10 of exhibit 56. Perhaps I can ask you this
23 question: If at the end of the period of consultation there is no resolution,
24 what is the next step? Resolution meaning you -
25 A: Yes, we can't get a consensus on this issue.
26 Q: Right.
1 A: I haven't thought about that in a legal sense, I must say. I've thought
2 about taking it, moving it up the chain really, up to my General Manager, to
3 the Chief Executive, with the Director General of Health, to decide what
4 now what do we do. I absolutely am aware that we have to do something,
5 so just to keep at the issue until we actually sort it out.
6 Q: Now in your own personal opinion, what is a reasonable period of time
7 to spend on consultation?
8 A: I think 6 months.
9 Q: And how many months have you been doing it already?
10 A: Well, in fact, we didn't actually specify a volume until July. What we
11 did in the first round of consultation was indicate that we wanted to specify a
12 volume and got opinions from the sector on that, on what it should be and
13 then considered all that in our own evidence and proposed the volume of
14 12,000. I don’t know whether one would consider technically the previous
15 period before proposing the 12,000 was consultation. I guess some people
16 might say it’s not. So if that’s the case we really couldn't say – if I say 6
17 months, then I guess I've got to wait until December to see if I can resolve it.
19 MR MURRAY: Madam Chair, I hate to interrupt again, but because these
20 are legal issues, if it did come to the crunch the laboratories could either be
21 told “these are the terms of the contract, sign up or not”, or s51 notices could
22 be issued. Again, s51 is still in the current statute and if you get to a certain
23 date and they don’t sign up, you can issue a s51 notice and if they then
24 process cervical smears and make a claim on the Health Funding Authority
25 they contracted on the Health Funding Authority’s terms. The blade can
26 drop and they have the choice.
1 CHAIR: With the s51 notice does that make them contracted in terms of
2 the old existing contract or does it bring in the new contract?
3 MR MURRAY: It would be whatever the Health Funding Authority
4 decided would be the terms of the s51 notice and many times this issue
5 arises if providers don’t want the Health Funding Authority’s contract that’s
6 been negotiated, and the Health Funding Authority runs out of patience, they
7 can say “Well, we are now putting our terms in a document, we are heading
8 it up s51 notice, it’s out there, it’s an offer to anyone who wants to contract
9 on those terms and if you don’t make a claim fine – you are not a provider
10 if you do make a claim, you are contracted on those terms.” So legally a
11 consultation, of course, as you well know –
12 CHAIR: Has to come first.
13 MR MURRAY: Has to come first, and that requires some obvious case law
14 assessment of what's a reasonable time. But assuming the consultation is
15 done lawfully, the contractual mechanism can be implemented whether
16 there's agreement or not.
17 CHAIR: Thank you Mr Murray.
19 PROFESSOR DUGGAN: Just one more question before the break. It’s a
20 definition, actually. Can you explain to me what single line accountability
22 A: I didn't write that. I think what the author – can I just find
23 Q: It’s on p10, under “What are we doing about it” – in that first para.
24 A: I must be on a different page.
25 Q: Sorry, it’s p18.
26 A: I think what the author was meaning was that while we were
27 responsible for the co-ordination, as is obviously apparent from this
1 discussion, we are not in control of the contracting process and the financial
2 aspects of the programme, and that creates some of the difficulties we are
3 seeing where the co-ordination and policy and monitoring arm of the
4 programme is separated from the funding and contracting arm and the two
5 don’t seem to come together. So we get – I think we’re just seeing those
6 problems today.
7 Q: Is that the usual understanding of single line accountability?
8 A: No, I really don’t like that wording, but in my absence someone’s been
9 writing these reports and I just haven't seen them.
11 CHAIR: Well, I think really we should take these reports at face value and
12 interpret them ourselves. I think that’s the best.
13 A: Well –
14 Q: And looking at p18, in the middle column it says “what can go wrong,
15 the programme has been established since 1990, however programme
16 components have not been purchased in accordance with detailed quality
17 standards and operational policies nor have effective programme monitoring
18 and quality improvement processes been established.” And when it said
19 “what are we doing about it” there is a comment that as the Inquiry has
20 progressed it exposes actual but correctable systems, failures, ranging across
21 the life of the programme. Principally these can be summated as the
22 absence of single line accountability for all inputs along the screening
23 pathway.” Now I don’t think that’s referring to the current situation of your
24 team and the monitoring team being separate, that seems to me to be a
25 comment on the history of the programme and various fragmented structures
26 it’s had.
1 A: It certainly seems to be that. Again, I've included these because they
2 are the reports that go from my team and ultimately I am responsible for
3 them, but in my absence I have had an acting manager and I haven't been
4 able to vet everything that leaves our doorstep. But I agree, it does seem to
5 refer to fragmentation.
6 Q: and this report has been written by someone who, in your absence, has
7 been recognised as being sufficiently responsible to fill in for you?
8 A: That is correct.
9 Q: What is this person’s background?
10 A: She has been a regional co-ordinator at the Southland cervical
11 screening programme site for a long time. I think she began as the regional
12 co-ordinator and then was a manager in the public health unit anyway in
14 Very well, we will adjourn until 2.15.
16 MR GRIEVE: Madam Chair, before you do.
17 CHAIR: Yes.
18 MR GRIEVE: I am going to have to get an even faster bike.
19 CHAIR: yes, what's happening.
20 MR GRIEVE: Madam Registrar has got -
21 CHAIR: Do you want them signed?
22 MR GRIEVE: I want them signed, please.
23 CHAIR: All right. Maybe we should delay so that we could get a seal
25 MR GRIEVE: I am a patient man, Madam Chair, but these administrative
26 problems are testing it.
1 MS JANES: Madam Chair, just while we are talking about patience, I
2 unfortunately have to communicate some news. Dr Hasan is convalescing
3 from a major surgery and would not be able to come in any event, so we’re
4 trying to get the information and hopefully that could all just come through
5 Dr Linehan. But I thought I’d just better advise the committee that it would
6 be unlikely, given his health, -
7 CHAIR: I have made an order that he come. That should be given to Mr
8 Grieve. He can serve it. If Dr Hasan wants to be excused, if it comes to
9 the crunch he can put up medical evidence as to why he should be excused.
10 We may as well cover all bases at this point.
11 MS JANES: that’s why I thought I’d let you sign it first and then tell you.
12 CHAIR: All right. We will adjourn until 2.15.
16 THE HEARING ADJOURNED AT 1.04 TO RESUME AT 2.15 PM
2 INQUIRY RESUMES AT 2:33 P.N.
4 PROFESSOR DUGGAN XXN WITNESS
5 PROFESSOR DUGGAN: Dr Peters, my question with regard to the single
6 line accountability was in terms of what your understanding about that is in
7 fact in regard to the second para in that same document, which is the
8 strategic approach, and perhaps you can explain to me how the screening
9 programme works. The discreet national screening unit within the
10 restructuring Ministry of Health responsible for single line accountability for
11 the screening pathways for the National Cervical Screening Programme and
12 breast screening.
13 A: Actually I'm sorry, even though an experienced person has written that,
14 that's a little confused. The approval of a discreet unit refers to the approval
15 that I received by the steering group, which was discussed in an earlier
16 exhibit and also has come through in the restructured Ministry of Health. So
17 that’s the submission that all functions will be aligned in one unit.
18 CHAIR: that’s public health unit, is that right?
19 A: Yes, the public health directorate, and that has been approved.
20 Q: yes, I remember you telling us about that.
21 A: But the submissions I have made for the staffing establishment which is
22 referred to below, has not had formal approval at the moment.
24 PROFESSOR DUGGAN: just dealing with that first para, is there a step
25 after the approval in April 2000 – is there a further step?
26 A: well, the step that needs to be undertaken is that the – yes, there is a
27 further step to align all the functions and the main function that isn't aligned
1 is the funding contracting function for both screening programmes is to
2 move the contracting responsibility and thus the funding responsibility over
3 to the screening unit or the public health directorate. In the case of breast
4 screening that is not a problem at all because the funding is already within
5 public health. It’s just a matter of changing, instead of the locality teams
6 undertaking the contracting and funding, my unit or team undertaking that
7 function. With cervical screening it’s a lot more complicated because at
8 the moment all the funds are bundled into generic contracts for laboratory
9 services in general or hospital and health services in general. And so we
10 have been developing a financial model bottom up to try and cost that, and I
11 think in my exhibit 52 I've indicated that at the moment we’re estimating
12 that’s about $30M.
14 CHAIR: So when do you intend to have this bulk funding unbundled and
15 directed to your unit? Is there a date at the moment on that?
16 A: The sort of unofficial date is for it to occur in the first 6 months of next
17 year, but I'm trying to make it clear to my superiors that without a financing
18 contract team my team can't do contracting. And at the moment I don’t –
19 even the concept’s been approved, I haven't actually had approval for the
20 staff. Although I'm receiving positive signals, I actually don’t have the
21 approval at the moment.
23 PROFESSOR DUGGAN: so that I can understand this in plain English,
24 this unbundling of service volumes, is this the unbundling of the cost of the
25 personal health service component of the screening programme and that’s
26 going to be transferred to you?
27 A: Yes.
1 Q: And is this all aspects of personal health as it relates to the screening
2 programme or is it only some?
3 A: It’s all laboratory services, all colposcopy services, although I
4 understand that the personal health aren't convinced that there is some
5 debate about whether we should fund treatment that is done at colposcopy.
6 But in general, let’s say all colposcopy just for simplicity, and all bulk fund
7 smear taking services where there's no user pays involved. And also the
8 Register and health promotion activities which are currently – well, they are
9 under public health already, but with the locality teams.
10 CHAIR: So until the unbundling is completed, you are not going to be in a
11 position to be fully operative in the way that you contemplate?
12 A: No.
13 Q: Your reference to structure and staff establishment.
14 A: Yes.
15 Q: The need for more staff, is that relating to the contracting need or
16 does that also include the experts we talked about earlier on, the
17 epidemiologist, biostatititians and other persons that you had listed to me as
18 persons you would like to have employed in your team.
19 A: It refers to both.
20 Q: How many staff are you seeking approval for?
21 A: I think in total, I think I said to you last time 30 excluding secretarial
22 and communication staff.
23 Q: Right.
25 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
26 PROFESSOR DUGGAN: Is that 3-0?
27 A: Yes.
1 Q: And these are FTE’s?
2 A: Yes.
4 CHAIR INTERJECTS AND XXN WITNESS
5 CHAIR: What's the likelihood of that being approved it seems quite a
6 large number of staff to be approved in one go?
7 A: Yes and it may not even be an accurate estimate but it's the best
8 estimate we could make. Yes it does seem large and it may need to be
11 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
12 PROFESSOR DUGGAN: Your existing staff number is what?
13 A: Well my existing official allocation is 7.5 full time equivalents. I’ve
14 got 4 fixed term contract staff and I’m just trying to think whether any of
15 those are dedicated to cervical screening. 1.5 of those are dedicated to
16 cervical screening and then I’ve got a range of consultants who do work on a
17 part time basis and at the moment most of their contracts would expire by
18 the end of the year.
20 CHAIR INTERJECTS AND XXN WITNESS
21 CHAIR: Right I’ve see you set something out at paragraph 6 where you
22 say you’ve got 7.5 full time equivalent staff with 4 full time fixed term
23 contractors and approximately 6.5 full time equivalent consultants.
24 A: Yes I added all the consultants hours up and divided them by 40.
25 Q: And did I hear you say you’ve actually only got 1 point something
26 full time dedicated staff members to cervical screening.
1 A: No I was just contemplating the full time fixed term contract staff and
2 2.5 of those are dedicated to breast screening and 1.5 to cervical.
3 Q: The 6.5 full time equivalent consultants, what is the reality behind
4 that because it's all very well to tally up consultants hours and say well it
5 comes up to 6.5 full time equivalent but it could be a number of consultants
6 working for a very small number of hours per week or even less than per
7 week on a matter to do with the programme is that correct?
8 A: There's a huge variability in the number of hours which we get from
9 consultants and while I think consultants are often very useful and
10 sometimes to get the expertise you need that is the only way you are going to
11 get it. I would prefer to see a move to build up the expertise internally
12 otherwise it's difficult to really plan your activities and be sure that you will
13 be able to carry them out.
14 Q: Yes because you would be dependent on the availability of the
15 external consultants wouldn’t you. Is that correct?
16 A: Yes but also when they leave they take – I mean there’s a certain
17 amount of that anyway but they take their knowledge with them.
18 Q: And there would be institutional memory being lost.
19 A: Yes.
20 Q: Just to finish off, the 30 staff that you want, is that over and above the
21 7.5 FTE equivalents you have at the moment or it includes these.
22 A: Inclusive.
23 Q: But of that 30 would you want a number of them to be full time staff
24 members with the programme?
25 A: Yes I would. I mean the 30 may not be correct but I’ve just estimated
26 the volume of contracting that would need to be done. I know that it's taking
27 2 people to manage the outcomes of monitoring of the Breast Screening
1 Programme so I’m envisaging there wouldn’t be any less than that for
2 cervical, in fact we could do with more than that on breast screening so a
3 monitoring quality assurance team of 4-6 I think is probably a minimum so
4 I’m basing it on some knowledge but it may not be absolutely accurately.
6 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
7 PROFESSOR DUGGAN: Built into these staffing numbers have
8 you included individuals who will monitor the implementation of the
9 contracts, details of the contracts?
10 A: Monitoring whether things are being done?
11 Q: Yes.
12 A: I would see that the quality assurance team would do that, but yes I
13 have built that in.
15 CHAIR INTERJECTS AND XXN WITNESS
16 CHAIR: Just so that I can be sure, because you’ve said over the page at
17 paragraph 6 you’ve mentioned monitoring and quality assurance, the quality
18 assurance team is that going to be a unit within your public health
19 directorate or are you talking about the auditing and quality assurance group
20 that Tracey Mellor and Jim DuRose belong to?
21 A: No I’m talking about in my unit.
23 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
24 PROFESSOR DUGGAN: I just would like some clarity on this
25 particular item. I don’t want to use the word monitoring, I’d rather describe
26 the function. The function is ensuring that the national policy and quality
1 standards as described in chapter 5 are in place. Your group is going to do
3 A: Yes and also when monitoring reports come from the monitoring
4 group issues are identified, I know this from breast screening, for example a
5 provider might be having a high recall to assessment rate and the monitoring
6 report demonstrates that. You have to have people who follow that up. Go
7 to the provider and say you know we need some explanation we need to
8 investigate this further so I need people who can do that.
10 CHAIR INTERJECTS AND XXN WITNESS
11 CHAIR: Right so you will have people in your group who when they
12 get information fed back to them will read that information and follow up on
13 the signals that information sends out to them.
14 A: Yes.
16 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
17 PROFESSOR DUGGAN: Still on the same page, page 18, the
18 strategic review of the screening programme is underway. Have you
19 previously given us information on this?
20 A: I said that in my initial brief of evidence that we were undertaking
21 this work, I said it in my initial brief. I think really it's probably I would call
22 it more a strategic analysis, and analysis of where we’ve come from and
23 where we are at the moment. I don’t thin we’ve got to the point of looking
24 to the future.
26 CHAIR INTERJECTS AND XXN WITNESS
27 CHAIR: And there is a document to that effect in your original brief.
1 A: No because it's been in such a draft form I haven’t produced it, very
2 much a working draft.
4 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
5 PROFESSOR DUGGAN: Part of this strategic review does not – no
6 I don’t need to ask that. If you could go to page 19, have you previously
7 given us information of the strategic review of the information systems.
8 A: That is a strategic review of the breast screening information systems.
9 Q: Are you planning one for the cervix or do you think it's necessary?
10 A: I don’t know that I know enough about it to comment at the moment.
11 I mean I’m certainly aware that there are issues in terms of transfer of
12 information from laboratories to the Register. It’s probably something that
13 needs to be reviewed, but my first priorities are to establish the quality
14 standards, implement those, establish monitoring and get that happening,
15 ensure that the unbundling or transfer of financial responsibilities occurs and
16 maintain my team in the transition period. And I suppose I haven't thought
17 a great deal of what we might do beyond that at the moment.
19 CHAIR: Dr Peters, I’m just a bit confused by what you’ve said here
20 because this whole document, from what I can see, refers everywhere to
21 cervical screening. I haven't seen anything relating to breast screening at
23 A: Sorry, yes.
24 Q: You’ve got the column “What can go wrong”, and you’ve got a
25 reference page –
26 A: Yes, I take your point on that.
1 Q: A number of pages here. I think “What can go wrong” talks about the
3 A: You're right. First of all the report, people don’t necessarily change
4 the report every month, you update it from time to time. Furthermore, I
5 know that initially we considered doing a combined strategic review of the
6 information systems but moved away from that, and that may be why that’s
7 still there.
9 PROFESSOR DUGGAN: I’d like to summarise your priorities as you’ve
10 listed them, based on this document on p18 and 19 of this exhibit. Your
11 first priority is to finalise the national policy and quality standards
13 A: Yes.
14 Q: The second priority is to finalise the national evaluation and monitoring
15 plan for the National Cervical Screening Programme?
16 A: Yes, and finalise the contract with the monitoring group.
17 Q: That’s all included?
18 A: Yes.
19 Q: The third priority is to unbundle the service volumes?
20 A: Yes.
21 Q: And the 4th one is to maintain the integrity of your team?
22 A: That’s correct.
23 Q: Are there any other tasks in that priority list?
24 A: The only other one I would add at the moment is to start producing a
25 detailed brochure for women about the screening programme which covers
26 the range of information that really women need to be able to make an
27 informed choice about participating.
2 CHAIR: I’m just going to ask a few more questions on this document. If
3 we could go back please to p1, this is something that Ms Janes was asking
4 you about. She asked you about the comment in the second para about no
5 national quality standards have been developed for programme providers
6 and you referred to the 1991 recommendations for laboratories which CALC
7 had produced and which were adopted by TELARC, and you agree that that
8 was not part of the programme.
9 A: Yes, I agree.
10 Q: And in terms of the 1995 laboratory standards, again I believe you may
11 already have agreed this, that that, too, was not part of the programme.
12 A: It seemed to be developed by a committee associated with the
13 programme but the programme didn't implement them.
14 Q: No. And the only time that any quality standards have been imposed is
15 really when the RHA signed the contracts with laboratories which required
16 laboratories to be TELARC accredited; it could be said, well that was a
17 standard that was being required for the programme, do you agree?
18 A: Yes.
19 Q: And in terms of monitoring, firstly in terms of laboratories, there has
20 been little monitoring in terms of laboratories, would you agree or not?
21 A: Not by the programme I would agree.
22 Q: Nor has there been any evaluation by the programme, would you agree
23 or not?
24 A: There have been, and I listed some evaluations, but not of the whole
26 Q: No, I saw those in your brief but you haven’t provided them so we can't
27 see them.
1 A: For example, I think the Norton Review you have seen.
2 Q: yes.
3 A: To me that is quite a useful planning document and it gives quite useful
4 information as a basis for planning. So it does evaluate the situation, but I
5 wouldn't call it programme monitoring or evaluation.
6 Q: and you’ve said at para 10 that the reports you’ve referred in para 9 are
7 not the type of monitoring and evaluation reports required for the purpose of
8 detecting potential failures within the screening programme.
9 A: that’s correct.
10 Q: So by and large the statement at p1 is an accurate statement of the state
11 of the programme probably even now?
12 A: That’s true. That’s why I've kept the risk high.
13 Q: And then at p10, first at p9 there's a lot of repetition –
14 A: As I say, they don’t get changed every month.
15 Q: is there anything different with any of these pages?
16 A: They get briefer and then they do change just towards the end.
17 Q: So is there one for each month, I hadn't picked that up.
18 A: Hmm.
19 Q: There's a comment, p7 is an example, which says that the programme
20 has – I think it was the Inquiry has highlighted the lack of mandated
21 operational policies. Do you agree that there are no mandated operational
23 A: Yes, I’m certainly not aware of any. I suppose the legal requirements
24 of s74A might be an operational policy, but in terms of policies appended to
25 contracts as part of the contract, no.
26 Q: In those terms it seems to me at the moment there are the laboratory
27 regulations which require I think that smears are to be read by either a
1 medical practitioner or some other person holding certain qualifications
2 supervised by a medical practitioner, so that would be a minimum mandated
3 standard, you couldn't have someone else reading them?
4 A: No.
5 Q: And 74A in terms of accessing information from the Register is a
6 mandated standard, but apart from that, are there any others?
7 A: Not that I’m aware of.
8 Q: Would you agree with the thrust of that paragraph, that's the second
9 paragraph page 7?
10 A: I mean I would put the emphasis on mandated because there are
11 policies, there is the 1996 policy, there are the recommendations for cervical
12 screening but the issue is whether there is any obligation to comply with
14 Q: Yes that's right. All I want to know is, the paragraph at page 7
15 appears in a similar form at page 8, page 9, the general thrust of the
16 paragraph being I’ll read it out, the inquiry has highlighted the lack of
17 mandated operational policies, quality standards and ongoing monitoring
18 which are required to ensure that the key organisational requirements for a
19 successful population based screening programme as defined by the World
20 Health Organisation are met. Now I just want to know whether you agree
21 generally with the sentiments of that paragraph.
22 A: What page are you on.
23 Q: Page 7 under the heading what can go wrong?
24 A: Can’t be 7, 17 is it?
25 Q: It's says 7.
26 A: Sorry I’m looking at the wrong page.
27 Q: Do you have page 7.
1 A: I don’t seem to.
2 Q: Left hand corner number 7.
3 A: I see. It doesn’t say the inquiry it just says it has highlighted.
4 Q: Yes if you read up above it, it's the investigation sorry yes.
5 A: Yes I agree with that.
6 Q: At page 12 it said, just an example, that the National Cervical
7 Screening Programme has been established since 1990. On what basis is it
8 reported here as having been established since 1990?
9 A: Well when I wrote that I undoubtedly thought it had been but from
10 what Mrs Marshall said yesterday in other readings clearly it wasn’t fully
11 established until early 92.
12 Q: Right and you say if we look at what's said there it says programme
13 components, still at page 11, have not been purchased in accordance with
14 detailed quality standards and operational policies, nor have effective
15 programme monitoring and quality improvement processes been established.
16 Do you agree with the sentiments expressed in that paragraph on page 11?
17 A: Yes to the best of my knowledge that's the situation.
18 Q: The strategic review that your involved with, have you in that draft
19 document identified what you think needs to be done to improve the
21 A: I don’t really think we’ve got that far. Probably one of the things I
22 was looking to it for was some sense of structural planning for the future in
23 terms of I think as I mentioned last time the laboratory regional site
24 coordination configuration that triangle seems to me to need some thought
25 and planning for the future.
26 Q: You mean in terms of regions, in terms of smear-taking, education –
1 A: Well in terms of the fact that in the past smears were generally read at
2 a laboratory that was close to the co-ordination site so there was a direct
3 relationship between the Register site and the laboratory. Now we have
4 smears going all over the country and say perhaps just an example,
5 hypothetical, you know possibility smears from Taranaki going to
6 Christchurch and then the results getting sent back to Taranaki to be entered
7 into the Register it seems, I’m saying there isn’t a role for local co-
8 ordination but I just think things are changing and that needs a look at and
9 I’m also a bit concerned that the Register sites because they generally have a
10 small number of staff, I mean the Auckland one would have say 16-20
11 because of the volume of smears being entered but you’re very dependent on
12 perhaps 1 or 2 people running the Register and knowing what things mean
13 and the letters and all that kind of thing and they do get great support from
14 Sandy Matcham but I do just wonder about the vulnerability really so that's
15 one of the things I was, in the strategic review, thinking of structural
17 Q: Where you’ve got smears say take for example Bay of Plenty which is
18 an area with a high incidence of high grade abnormalities. If a large number
19 of smears from that locality were being read in another locality in a
20 laboratory where there was a very low incidence of high grade abnormals,
21 what impact would that have on the statistical analysis if you don’t tie the
22 smears back to the region from which they’ve come from?
23 A: Well I actually think it makes it quite difficult and I’ve talked to Dr
24 Cox about this in the sense that you can certainly analyse, first of all you
25 don’t really know what your denominator population for the laboratory is
26 just because perhaps from a region smears might be going say to a couple of
27 other laboratories out of that area. It's difficult for the monitoring group to
1 know what the denominator population for the laboratory is and therefore, I
2 don’t’ want to get myself confused here, you could still do cytological
3 abnormalities per 1,000 women for that region and link that –
4 Q: Link it back to the region where they came from?
5 A: To the region they came from but if you were concerned that perhaps
6 you weren’t getting the rates of cytological abnormality that you would
7 expect because say the incidence of cervical cancer you would then have to
8 do some kind of fancy statistical work to exactly work out where the smears
9 were being read -
10 Q: it would be one of those situations where you would have to go back
11 and find out from the laboratory wouldn’t you perhaps.
12 A: Actually you would know which laboratory they’d been read at. I
13 might be getting confused here but I do think it does create some monitoring
14 difficulties and I know at the meeting on Fri the pathologists there said they
15 would like some outcome data meaning incidence data related to their
16 catchment as they called it.
17 Q: Right and will you be able to set up, if you don’t already have it,
18 information systems that allow that to happen given that smears are now
19 being sent to laboratories outside of the catchment area.
20 A: I don’t think it's insoluble and Dr Cox said he would look into it for
21 our next meeting on 1 Sept to see. He would look at the issues so when we
22 all came together again to work on the indicators we could discuss it again.
24 PROFESSOR DUGGAN: In your opinion are the issues with the Register –
25 this is the Cervical Register?
26 A: It seems pretty simple compared to the breast screening one. Well, I
27 think there's one obvious issue and that is that we don’t know what the data
1 quality is that we’re receiving from the laboratories, and to my knowledge
2 there haven't been any data audits undertaken. Although I know Jim duRose
3 did find that there were data quality problems when he did his review, I
4 don’t know how extensive those are. I suspect that the Register sites don’t
5 do the same thing all around the country, but I don’t know whether that is a
6 problem, I just think there is some regional variability. It’s also as we've
7 discussed, we don’t have a population based register, it’s a – I forget what
8 you called it – a utilisation register – so we don’t really know anything about
9 the women who are not either enrolling in the programme or not being
10 screened at all.
11 Q: What's the importance of that?
12 A: Well, we can't determine what the barriers are really to screening, we
13 can't survey those women and find out is it a cost barrier, is it that they are
14 fearful. I mean, we can surmise things from the literature but we don’t
15 really know.
16 Q: So can I deduce from your statement that if you wanted to improve the
17 outcome of the programme further that this would be a priority group for
19 A: Yes.
20 Q: Those who are currently unscreened.
21 A: Yes.
22 Q: Any other issues with the Register?
23 A: At the moment we don’t collect any colposcopy assessment data.
24 Again that may be a council of perfection, but I guess to really be able to
25 monitor your assessment clinics or your colposcopy clinics that would be
26 useful. And then, although I haven't explored it at all really in great depth,
1 we've got to get this linkage sorted out between the Cancer Register and the
2 Cervical Screening Register.
3 Q: there are no barriers to linking with the national health index database
4 are there?
5 A: Not that I'm aware of, but I will need to get you to ask ms Matcham
6 about that. It seems to me national health index’s numbers are checked for
7 accuracy and it doesn't seem to be a problem.
8 Q: Now in this new structure, the register is part of your unit?
9 A: Yes, and that’s part of the 7.5. the two people who manage the
10 Register at the moment are part of my –
11 Q: 7.5 [inaudible].
12 A: Yes
13 Q: Not chapter 7.5?
14 A: No.
15 Q: And does the Register co-ordinator report to you?
16 A: Yes, since March this year, yes, she does.
17 Q: And the regional Register staff, who do they report to?
18 A: They report to their line manager in the hospital and health services.
19 Q: So do we have a fragmentation here?
20 A: Well, they also have a very close relationship with Ms Matcham,
21 although it’s not a management relationship, and I mean one could say it is
22 fragmentation, but if all the people in the whole screening programme were
23 going to be employed by my unit, whoever was the manager, would have a
24 huge staff. It’s not unlike, I suppose, I think Dr Duncan raised the issue of
25 designated officers, they link closely with the Ministry of Health and the
26 Director General but their line management is within the public health unit
27 where they are employed.
2 CHAIR: What are they called now – HSSs are they?
3 A: HHSs, Hospital and Health Services.
4 Q: They used to be CHEs didn't they?
5 A: Yes, that’s right.
6 Q: They are separate legal entities aren't they?
7 A: Yes.
8 Q: And the regional co-ordinators are employed by them still?
9 A: Yes.
10 Q: And there is still a regional register?
11 A: there are 14.
12 Q: And the information goes to them and then gets transferred, or is it all
13 linked to a national Register?
14 A: I'm assuming – well, it’s all linked.
16 PROFESSOR DUGGAN: so the regional registers are funded by the HHS?
17 A: they are funded by us, by the Health Funding Authority
18 Q: Ultimately?
19 A: Yes. Through their HHS usually probably their public health contract,
20 the Hospital and Health Service public health contract.
22 CHAIR: So the regional register is based with the HSS and there is a
23 funding contract between the HSS and the Health Funding Authority
24 A: Yes.
25 Q: Which will soon be the Health Funding Authority swallowed up within
26 the Ministry of Health for the performance of the work related to the
27 regional register?
1 A: Yes.
2 PROFESSOR DUGGAN: the issues that you have identified for me with
3 regard to the Register and I will explore the same, I will ask Ms Matcham
4 for the same list. Maybe she’ll have another list.
5 A: She might.
6 Q: Who has a responsibility for resolving these issues?
7 A: At the moment it would appear to be – well, not me ultimately, but I am
8 responsible, yes.
9 Q: Now in your priority plan that you gave me, where does this fit?
10 A: Well it’s clearly not in the top 5 because I've give you my top 5. It
11 would be getting quite close to the top but I do feel we've got to finish what
12 we started at the moment before we move onto anything else.
14 CHAIR: Could I just be clear with your team do you ultimately envisage,
15 because you’ve talked about having a funding contracting role and funding
16 contracting directly with laboratories, do you also anticipate direct
17 contracting and funding with the regional co-ordinators of the HSS?
18 A: Yes, those are at the moment funded through the public health locality
19 teams and they are another bundle of contracts that would be transferred to
21 Q: So that will be unbundled and come to you?
22 A: Yes.
23 Q: And when the 22 District Health Boards are in place, is it envisaged
24 that in respect of the components of the scheme that are provided by those
25 22 District Health Boards that you will have direct control and authority to
26 contract with those Health Boards in terms of what they are to deliver, or
27 provide, and you will have the money to determine funding with them?
1 A: Well, that’s very much my preference and I have made my views
2 known. I know within the new Ministry there is going to be a funding
3 directorate and I think when I was here last time I said I wasn’t clear
4 whether we would do the direct contracting or whether we would specify
5 what was required to that directorate and they would go and do it. But I've
6 certainly had assurances from Dr Poutasi that my unit would have the
7 funding and have the, I guess the authority to stipulate what was required.
8 Q: In an negotiation situation would it be better if the negotiations were
9 carried out by someone from your team in terms of that person being better
10 informed as to what issues to give way on and what issues to hold firm on as
11 opposed to someone coming from a funding unit dealing with funding
12 matters and contract matters generally?
13 A: I’d certainly prefer it and if it wasn’t to be I’d certainly want to have
14 some input because I became aware when we did the funding with breast
15 screening it was very valuable to have someone from my team there to
16 ensure that national consistency in the way things were funded was
18 Q: Yes because otherwise as different contractual negotiations develop
19 you may find differences occurring with different District Health Boards just
20 as part of the negotiation process.
21 A: That's right. People who are very dedicated to a region are aware of
22 the special characteristics of the region and get persuaded that it would be
23 alright to do things a little differently where with the national programme it
24 seems to me that it's important that in as far as possible everyone’s doing
25 things in a similar way if not the same, a consistent way.
26 Q: Given that there are going to be 22 District Health boards and in the
27 past there have been 14 regions and 14 registers, what is going to happen in
1 terms of, given there’s going to be 22, I don’t imagine you will split the 14
2 into 22 so do I take it that in some instances a Register which has been
3 associated with a particular region will have to deal with more than one
4 District Health Board.
5 A: That's correct. My understanding is that each of the 22, there will be
6 a population based funding formula and I imagine if hypothetically one of
7 the regional sites is covering two District Health Boards the funding would
8 be top sliced before it went to the District Health Board to cover that
9 regional site.
10 Q: And who would be responsible for employing the staff at the regional
11 site then.
12 A: They’d still be employed by the HSS or the District Health Board
13 they are already employed by.
14 Q: Yes but as they are now going to be split into 22, see I’m thinking if
15 you take a situation with a region that suddenly finds itself with 2 District
16 Health Boards what's gonna happen to the regional co-ordinator, is she going
17 to be a part-time, you know an employee split between the two District
18 Health Boards or will one District Health Board have to take the
20 A: I mean of course I can’t say exactly how it will work because I don’t
21 know but what I would envisage is that the District Health Boards would
22 probably come to an agreement that that register site is serving two District
23 Health Boards and therefore the funding say from District Health Board
24 number 2 would be transferred to District Health Board number 1 to enable
25 them to run that service for both of them.
1 Q: Doesn’t that leave room for management breakdown? It's very
2 dependent on two District Health Boards working in a cooperative fashion
4 A: Yes I’m starting to get into speculation as to how it might work. I
5 know that there is thought the District Health Boards will combine their
6 efforts for various services because it would simply be –
7 Q: Would this be a case for having the 14 regional sites coming under
8 the umbrella of the national programme so that they be satellites of the
9 national programme employed by the Ministry of Health, Health Funding
10 Authority so that they become employees of yours but based in –
11 A: Just housed in those –
12 Q: Yes housed in those District Health Board areas and they would
13 remain as 14 offices.
14 A: It's really not something I’ve thought through. I mean I see it's a
15 possible concept but I haven’t – I’m just reluctant to comment on something
16 I haven’t really thought about.
17 Q: The reason I want to pursue this with you is because my
18 understanding is at the moment the information is entered on regional
19 registers isn’t it?
20 A: Yes.
21 Q: Because if smears are going out of catchment areas to different
22 laboratories the ability to make sure that nevertheless the reports are entered
23 in the Register in such a way that the information is still tied to that
24 catchment area is going to be very dependent on the quality of the staff and
25 ho well the, I’ll call it the regional office, the regional register office still
1 A: Yes but if you enter something into a national register and you come
2 from Tairawhiti for example and your information just happens to be entered
3 in Wellington, your still going to know that person came from Tairawhiti
4 and DR x was the smear-taker and that the smear was read at laboratory – I
5 mean Ms Matcham I know will correct me if I’m wrong but I would have
6 thought that would be entry point probably. I think where the regional
7 registers are important or certainly have a role is that they know their
8 populations and so they know particularly the way that it's set up at the
9 moment if – they use their networks to make sure things happen for people
10 so if a person doesn’t appear, has been signed out for treatment but has
11 never seemed to have – that doesn’t seem to have been completed, they will
12 investigate what has happened and I think it would probably be true that if it
13 was all being done in Wellington, that those kind of local relationships
14 would not exist and –
15 Q: I’m not suggesting that the local person wouldn’t be there but rather
16 that that person would be an employee of the main office in Wellington. In
17 other words there would be a national housing office, wherever it's housed,
18 Auckland or Wellington and that the persons who are currently at the
19 regional Register sites associated with the programme and employed by the
20 HSS rather than become employees of a composite District Health Board,
21 become employees of your unit.
22 A: Well it's a possibility but I haven’t thought through all the issues
23 associated with that but –
24 Q: If they were to remain in the regions and become employees of more
25 than one District Health Board would you be able to ensure that funding in
26 respect of the programme was properly tagged so you wouldn’t have a
27 situation where there was a tension developing because one District Health
1 Board wanted to spend less in terms of the Register staff, health education,
2 anything to do with the programme in that region than the other District
3 Health Board.
4 A: I can’t envisage a situation where one person would be an employee
5 of two District Health Boards. I think realistically what would happen
6 would be that one District Health Board would give up it's funding to the
7 other one to ensure that the service was maintained by the other District
8 Health Board for the benefit of both boards.
9 Q: And is the programme or anyone else at the Ministry of Health going
10 to have the power to come in and determine a situation where two District
11 Health Boards are in conflict as to what amount of money will be given up
12 and how money will be dealt with?
13 A: I just don’t know – it's just something I haven’t explored at the
14 moment. I just don’t have any details on it.
15 Q: Yes we’ll adjourn until 3:45.
17 INQUIRY RETIRES UNTIL 3:45 P.M.
21 INQUIRY RESUMES AT 3:46 P.M.
23 PROFESSOR DUGGAN: Dr Peters, given the creation of the 22 District
24 Health Boards and the complexities and fragmentation that will ensue for the
25 Register, do you think a critical review of the Register should be moved up
26 the list of priorities?
1 A: Yes. I think the reason that is in the risk report is that was our original
2 intention, and then, I guess, felt we were just taking on a little bit much all at
3 once and we definitely knew we needed to do the breast screening one, but I
4 agree with you.
5 Q: So in your current list you have number 5, which is the last one,
6 detailed brochure with regard to information for women?
7 A: Yes.
8 Q: Where would you like me to put the strategic review of the Register?
9 A: You can put it above that one.
10 Q: So number 5?
11 A: Yes.
12 Q: And the brochure becomes number 6. The women affected’s evidence,
13 in several of them I noticed the following: prior to the creation of the
14 National Cervical Screening Programme, be it 1990, 91 or 92, they had had
15 many smears over the preceding years, and I noted that those smears prior to
16 1990 were considered as part of the eligibility criteria for enrollment – i.e., if
17 they'd had a smear in the previous 5 years they were automatically enrolled
18 without having to go through -
19 A: Having one 12 months apart.
20 Q: In your opinion is there any weakness with that approach?
21 A: I’m not convinced that that’s the case. I'm not sure how the Register
22 operated then and whether they would have been, it being their first smear
23 on the Register, whether they would have been recalled in a year or not.
24 But if that was the case that they weren't – I'm not quite sure what sort of
25 weakness you're thinking about. I mean, I can see that if the Register wasn’t
26 aware of a woman’s screening history, then –
1 Q: I'm not saying it’s the only weakness, but these smears were all
2 interpreted in laboratories that were not accredited prior to 1990.
3 A: Oh I see what you mean.
4 Q: there were no standards for cytology prior to 1990.
5 A: So that if the screening programme had been started and said to women
6 this is your first screening round in the screening programme and the
7 laboratories are accredited, yes, I can see it would make sense for them to
8 have a smear 12 months hence after the first one, and I'm not sure if that was
9 the case or not.
10 Q: And even although it’s been unclear to me, I did actual ask Dr Boyd
11 this question and he wasn’t clear either as to what approach was taken with
12 regard to these smears that were performed prior to the programme being
13 implemented. However, in terms of today and let’s say a woman enrolls
14 today, has your group given any consideration to ensuring that the smears
15 used to enroll women received the best interpretation possible?
16 A: Well, I think that’s the whole purpose of the quality standards and
17 implementing monitoring, that they do receive the best interpretation.
18 Q: You haven't considered going further even in terms of, for example, all
19 smears used to enroll women will be double screened, for example?
20 A: No we hadn't considered that. I’m not saying we shouldn't consider it,
21 it’s something we haven't considered.
22 Q: You'd agree there is some danger in your 3 year screening interval in
23 that if a woman has, although the possibilities are low, two under-reported
24 smears and goes on a 3 year cycle it may be 3 to 4 years before she returns
25 for her next smear?
26 A: Yes, I agree.
27 Q: Just a few small items.
1 A: Can I just clarify something with you. If a woman has been having her
2 smears read at the same laboratory for all her screening history but then a
3 day comes when she decides, having not been enrolled in the programme
4 she’s going to enroll but the smear goes to the same laboratory, I understand
5 from what you're saying to me that you think it makes sense to have that
6 smear double screened because that’s an enrollment screen in the
8 Q: All alternatively one could consider re-screening the smears prior to
10 A: Right, yeah.
11 Q: What I’m really exploring with you here is safety mechanisms associated
12 with your enrollment criteria.
13 A: Yes.
14 Q: Now yesterday I asked Mrs Marshall some pointed questions about
15 medical support or opposition to the National screening programme and she
16 thought you might have some comments on this. My question to her was
17 more with regard to the history of the programme. I could narrow the
18 question for you and ask you about today. Is there opposition to the
19 screening programme today or is there overwhelming medical support?
20 A: I'm not really aware of extensive opposition. I feel we've had good
21 support from the colleges through the process we’re going through at the
22 moment. People seem willing to attend meetings, want to be consulted with,
23 enrollment on the Register is high. I know that the co-ordinators do report
24 to us pockets of resistance of perhaps smeartakers who continue to not give
25 women the opportunity to be enrolled. But I do think that – and I’d
26 probably need to explore with them more how extensive that is, but my
27 feeling is that it is pockets rather than a major problem.
1 Q: Will your proposed evaluation and monitoring plan identify this?
2 A: Well, the national indicators can't really do that because we’re only
3 monitoring the people who are enrolled. But an evaluation of a survey of
4 smeartakers or a survey of women could actually discover some of the extent
5 of that problem.
6 Q: Exhibit 55, F, p9, the second table, the third row down, aged 30 to 34
7 enrolled at month end and the %s 100.28.
8 A: Yes.
9 Q: Would you care to comment on such – it’s obviously an error, would
10 you agree it’s an error?
11 A: I would think so.
12 Q: That’s just to demonstrate to you that we do actually read all the rows
13 in the columns.
14 A: Yes. I notice actually it’s persisted in the next G as well. I mean it
15 clearly can't be true, but it may mean that there are people in the numerator
16 who shouldn't be there who are not in the denominator. I know the Register
17 does its best to ensure that people who have left the country are not include
18 in statistics. But it certainly appears as though either that’s an error or there
19 is a problem.
20 Q: From Ms Matcham’s evidence it’s clear that the duplicated entries in
21 the regional registers which were identified when the system was
22 reconfigured created a lot of problems in terms of the data. Have you or
23 your group looked at the statistical reports generated by the programme prior
24 to your statistical report, which is in draft form, to determine if the clean up
25 of the data has had any impact on the enrollment and coverage figures
26 produced over those preceding years?
27 A: No we haven't.
1 Q: is it possible that these duplicates might have inflated the success of the
2 programme as reported in the statistical reports?
3 A: I think it is a possibility, definitely.
4 Q: Is there any obligation on your part to go back and address that?
5 A: You mean re-visit the analysis and the statistical reports.
6 Q: Of is there any obligation on anybody to do that or do we just live
7 with the potential error?
8 A: Well there may be an obligation but I mean I would need to say that I
9 have a public health medicine registrar with an interest in epidemeology
10 producing for me the 96-98 statistical report and that is a very big task which
11 is consuming all her time. I’m not sure how I would physically have that
12 other work undertaken. It may be very important, I’m certainly not
13 disagreeing with you that it is important, but I don’t even know now if it
14 would be possible, but even if it were possible I would need three extra
15 people dedicated to the task for another year, just realistically, to get it done.
16 Q: Well maybe Ms Matcham has a quick and dirty solution to this
17 problem. Finally I have noticed that there are two definitions of coverage.
18 There’s the three year coverage and the five year coverage. Can you tell me
19 which one is the programme going to use?
20 A: Three yearly and we settled that definitely last Friday at the meeting
21 on the indicators.
22 Q: Something definite. That you very much.
24 CHAIR INTERJECTS AND XXN WITNESS
25 CHAIR: Dr Peters I understand that you accept that at the moment there
26 has been no comprehensive evaluation of the national programme is that
1 A: Yes.
2 Q: I note in the European guidelines for quality assurance and cervical
3 cancer screening it says, this is in respect of placing an organised screening
4 programme over local screening facilities already in existence, that before
5 that is done there should be a comprehensive review carried out. It seems
6 that you have a number of plans for change envisaged in exhibits 40, 42 and
7 47 in respect of statistical repots but I wondered whether or not in view of
8 the fact that you have inherited a screening programme which has been
9 running since 1991 perhaps early 1992 and there has not been a full
10 evaluation to date, whether or not you have thought it appropriate before you
11 continue with your changes to first of all ensure that there is a full evaluation
12 of what is there at the moment.
13 A: I’m not quite sure how to answer that I mean I think that’s true one
14 could have undertaken a review or an evaluation of what is there, but it
15 seemed to me that the screening programme wasn’t going to stop and there
16 were no quality standards and there wasn’t ongoing monitoring and I felt it
17 incumbent upon me to address those priorities first. Maybe the decision
18 should have been other than that but it wasn’t.
19 Q: So in that sense in respect of bringing in quality standards,
20 monitoring and evaluation are you really starting from scratch with the
21 programme in terms of that aspect of it?
22 A: Well I feel as though I am.
23 Q: Right. The Cox and Richardson evaluation which is at Glackin
24 volume 9 tab 47, are you familiar with that document?
25 A: I’ve certainly read it in the past.
26 Q: Well when Dr Cox gave evidence he said in his view the draft
27 evaluation plan in it's entirety was an essential exercise to carry out and it
1 was not a Rolls Royce plan. What is your view of that, should it be carried
2 out at some stage or do you think that the developments you are now putting
3 in place will overtake it?
4 A: I don’t think the developments I’m putting in place would overtake it
5 because this contains for example, there's an economic analysis which I’m
6 not undertaking, there's an evaluation for maori and pacific women which I
7 think from memory assessors would actually involved women not on the
8 programme so we would get some indication from that of perhaps why
9 women who are not being screened or not participating are not so what I am
10 putting in place at the moment would not make this unnecessary. I think the
11 issue would be prioritisation because it's a big undertaking and to complete
12 all aspects one would need to prioritise the order.
13 Q: Right I note for example at page 91 paragraph 8.3.1 there's a heading
14 does the programme provide adequate and appropriate data for evaluating
15 the programme and then there is a discussion about how data is needed for
16 evaluation where it will need to come from and the need to be sure that it is
17 available and then the next heading is action to be taken if the programme
18 does not provide adequate and appropriate data for evaluating the National
19 Cervical Screening Programme. It seemed to me given this document is
20 dated June 1997 we know now the difficulties that Dr Cox and Richardson
21 have run into in terms of getting access to data but it seems that is one of the
22 very issues that would have been addressed in their evaluation plan.
23 A: Well they are actually undertaking this part of it.
24 Q: Are they.
25 A: And this part is underway because it doesn’t involve identifiable data
26 so they have all the records with no identifying information and they are
27 actually doing this.
1 Q: When they talk about identifying the data required are they going to
2 deal with the legal obstacles to obtaining data or are they just looking at
3 what is being held?
4 A: I really – I don’t think they are looking at the legal obstacles. I
5 thought they were looking at the data elements as to whether that is all we
6 need to collect and also the completeness and the quality.
7 Q: Do you not think it would be worthwhile to at least have some
8 examination of what can be accessed because there doesn’t seem to be that
9 much point in having data stored if you can’t access it for relevant purposes
10 for the programme.
11 A: Do you mean the legislative obstacles?
12 Q: Yes.
13 A: Well I’m not sure whether that would be appropriate in this kind of
14 study. We’re already exploring those issues.
15 Q: It's just it's hard to see how you can say data is actually available if it's
16 there but can’t be accessed.
17 A: I guess it depends on what sort of monitoring and evaluation you are
18 wanting to do with the data. If it’s completely non-identifiable data for
19 quantitative analysis, then there is no obstacle at the moment; it’s access to
20 identifiable data that’s the issue.
21 Q: So my understanding then is that you do accept that the Cox/Richardson
22 draft evaluation plan would be something that was essential to carry out but
23 it would need to be done in stages?
24 A: Yes. I mean, I can't see any component here that I don’t think’s
26 Q: So you accept all the components are important?
27 A: Yes.
1 Q: In those circumstances, then, do you think it becomes important at
2 some time to ensure that all those components are in fact carried out?
3 A: Yes, and it might be that through some of the routine monitoring some
4 of it gets carried out anyway and could in fact – I mean, I’d have to look at
5 the plan again – be dropped off the list, although if this was a retrospective
6 evaluation our monitoring wouldn't cover that. For example, stage
7 distribution of invasive cancers, that’s one of our monitoring indicators, but
8 that will be going forward not looking back.
9 Q: This is partly the point I was making before, do you think it is
10 important to do a retrospective evaluation of the programme?
11 A: Hmm.
12 Q: So that you look back over the earlier period between 91 to 99?
13 A: Perhaps not every component, but I certainly think we could learn a lot
14 from many of these components even if they are retrospective because we
15 will be able to learn lessons for the future.
16 Q: the next point I would like to ask you about is I would like your view as
17 a public health expert and the manager of the programme, or the unit
18 responsible for the programme, on the circumstances surrounding the
19 Cox/Richardson evaluation of the programme and the sense that I
20 understand that there was a decision by the Ministry of Health in late 1996 to
21 have an evaluation of the programme, so the process was initiated late 1996,
22 and I understand that there was a contract signed on 28 January of 1997.
23 I’m taking that from p2481B of the transcript. So the contract was signed
24 on 28 January 1997, Doctors Cox and Richardson produced their draft
25 evaluation plan June 1997, because my understanding is there were funding
26 difficulties in accepting their entire plan so there was the revised version
27 which was in Sept/October 1998 – that’s shown at p2487B of the transcript.
1 And so there was a revised proposal filed by Doctors Cox/Richardson in
2 October 1998; it went out to tender – the Ministry tendered in February
3 1999; a contract was signed in May 1999, and they are now working on 3
4 aspects and I understand one is complete, one is partly complete and the
5 other hasn’t been completed because of the difficulty in getting access to
6 information both on the Cancer Register and the Screening Register.
7 A: Hmm.
8 Q: Given the time lines I've set out to you there, just as someone involved
9 in the programme in public health issues, what comment do you have to
10 make on the length of time it has taken to get to the stage where Doctors
11 Cox/Richardson are at now, and they are still faced with obstacles in terms
12 of gaining access to information they need to complete their evaluation
14 A: Can you just tell me what the first date was?
15 Q: The first date, the decision to have an evaluation was late 1996. So
16 you’ve got late 1996 where the process starts, contracts signed with
17 Cox/Richardson 28 January 1997; then their draft evaluation plan coming in
18 June 1997; then there is a period of delay while issues probably having to be
19 determined in terms of funding and whether it can be done or not, and
20 ultimately a decision is made for a revised version in October 1998, with a
21 tender going out February 1999 because it requires public monies and so
22 there's a fresh tender. Final contract signed May 1999, at which time
23 Doctors Cox/Richardson commenced the evaluation. So you’ve got an
24 exercise that was initially thought of late 96, doesn't finally get underway
25 until May 1999, and then of course it then runs into the stumbling blocks
26 that it has.
1 A: Well, I mean the 4 year – I mean, we are now coming up to 3 ½ years
2 since the initial decision was made. I can see how a complex undertaking
3 can appear to be delayed and yet due process is occurring – you know,
4 contracts are being let, plans are being devised, consulted on, etc., and so it’s
5 amazing how the months can slip by. But if you take the timeframe overall,
6 I think the fact that we’re going to be sort of close to 4 years from the day of
7 conception, or the idea was conceived or agreed upon, and it’s not complete,
8 that seems too long to me.
9 Q: And what is your view, given that the idea was first thought of in late
10 96, of the fact that it seems that it wasn’t until some time after the final
11 contract was signed in May 1999 and Doctors Cox/Richardson began
12 embarking on the evaluation exercise that the difficulty in carrying out parts
13 of the exercise was realised in terms of the legal obstacles to gaining
15 A: Yes, well we – I mean, I was actually the person who determined –
16 well, who first considered that there might be a legal obstacle.
17 Q: When you first began to think that what was the reaction around you,
18 had it been a matter that had dawned on anyone else before?
19 A: It didn't appear to have.
20 Q: what comment do you have on the situation where the Ministry of
21 Health, which can promote legislation such as the Health Act and which had
22 promoted s74A, does not appear, prior to some time in 1999 when you
23 thought of the matter to realise that there is a problem in gaining access to
24 the Screening Register for the purposes of carrying out an evaluation
25 exercise of the programme?
26 A: Your asking for my view as a medical doctor?
1 Q: And the manager of the programme how did you feel when you were
2 looking for this evaluation and you suddenly realised it may not happen?
3 A: I don’t know what I thought at the time I just thought that it seemed
4 strange to me that no regulations had been made. Well I wasn’t really sure
5 what the problem was and because of my lack of legal expertise I wasn’t
6 sure whether Section 74A overrode the Privacy Act or it was vice versa so in
7 fact I probably didn’t think very much at all, I just thought I better sort out
8 my legal position here and I sought a legal opinion about it. I think that's
9 probably what my thought processes were.
10 Q: Right well as the manager of the unit responsible for the programme
11 did you consider the evaluation exercise that was being undertaken to be
13 A: Yes it did.
14 Q: Well what impact did it make on you then when you realised that an
15 important exercise which had been commenced by the Ministry of Health
16 may not be able to be undertaken because of the absence of regulations
17 passed under Section 74A and the barrier 74A created to the evaluation team
18 getting access to the information it needed.
19 A: Well it seemed very unfortunate to me and also it seemed worrying as
20 to how we would proceed in the future. In fact I thin I said previously and
21 it's still the case that I was already seeking a legal opinion about audit of
22 interval breast cancers and cervical cancers but there was no urgency for me
23 at that time I was merely setting things up for the future and exploring the
24 legal position. When I received Dr Cox’ application for data I then realised
25 I had a more urgent problem and sought a further more rapid legal opinion
26 about the situation.
1 Q: Did you find any evidence that anyone earlier to yourself had any
2 sought any advice or had ever recognised that there could be a problem in
3 gaining access to the information.
4 A: No I didn’t.
5 Q: We’ve heard from Dr Cox that his gaining access to the Cancer
6 Register was hindered by decisions of the Ethics Committee requiring
7 consent from persons named on the Register and of course he couldn’t go to
8 them to get their consent because he didn’t know who they were. Given you
9 intend to use an outside monitoring and evaluation team for the programme,
10 how do you intend dealing with this problem?
11 A: That's one of the reasons I sought legal advice to see that to explore
12 for both programmes whether we can provide identifiable information about
13 women with cancer to an external agency.
14 Q: Do you think that monitoring, auditing, evaluation of the programme,
15 what I’m really meaning is a study which looks at how effectively the
16 programme is working and if it's failing or not, do you think that should be
17 done by an external team?
18 A: Do you mean this one off evaluation or monitoring and evaluation in
20 Q: In general.
21 A: I thin if you’ve got the expertise in house then you can do it but you
22 would need very specific expertise, more than just being an epidemiologist.
23 I think for a disease like, when I say just being epidemiologist I mean I think
24 you do need someone with cancer epidemiological expertise and I don’t
25 know how it is in other countries but I think we’d be unlikely to find a
26 person like that working in our unit. Furthermore as Dr Cox has made the
27 point to me in the past and I think it's true that there are some advantages to
1 an external agency in the sense that they can make comments about the
2 programme that may be the in house people if they did exist, would not be so
3 honest about.
4 Q: If you acknowledge the importance of having an external monitoring
5 team, it seems to me on my reading of the guidelines of Ethics Committees
6 which I’ve read today, they made allowances for an internal audit what
7 seemed to me to be employees is not requiring Ethics Committee approval
8 but I wasn’t so sure on reading the guidelines as to where external teams
9 came within the guidelines and it seemed to me in any event given the
10 difficulty that Dr Cox has already encountered that you would need to
11 grapple with this issue if you wanted to have monitoring and evaluation
12 continuing on a regular basis that you would want to ensure that there was
13 ready access to the information that was needed, is that so?
14 A: Yes again one of the issues I had wanted to seek some legal advice
15 about was where Ethics Committees fitted in to this process and I admit I’m
16 not really clear because I would have thought that something that was a
17 routine monitoring audit activity associated with the programme would be
18 considered a quality assurance activity and not a research activity.
19 Q: Are you in a position to promote legislative change if legislative
20 change is required as the only way of getting secure confident access to
21 information you will need to allow monitoring and evaluation on a regular
23 A: I’m probably not that familiar with the process. I would have to
24 discuss that with the Ministry of Health .
25 Q: Well as the programme manager at the moment, has anyone informed
26 you of how change can be brought about using legislation if that ultimately
1 turns out to be the only way in which you can gain access to the information
2 you need to monitor and evaluate the programme.
3 A: No-one has informed me but a member of my unit has been in contact
4 with the Ministry regarding these issues.
5 Q: I understand given that there are regional Ethics Committees have
6 you taken into account whether or not you will have to at the moment if you
7 need Ethics Committees approval, need to get the approval from more than
8 one Ethics Committee?
9 A: Well I haven’t because the monitoring I’m envisaging starting would
10 involve non-identifiable data and I can’t see that we would need Ethics
11 Committee approval for that and at the moment the effect of Section 74A of
12 the Health Act would preclude us from doing audits without the individual
13 consent of women.
14 Q: Have you therefore considered the need to develop a strategy to
15 ensure that the way is clear to both registers be that legal or some other way
16 of getting information, but I would think really the way to do it would be to
17 clear any obstacles so that you had a clear pathway to get information from
18 both registers. Have you done any strategic analysis of how that should be
19 done, when it should be done?
20 A: When you say both registers, you mean the Cancer Register?
21 Q: Yes.
22 Q: Well, we are just finalising this fairly extensive legal opinion at the
23 moment and I then expect to progress those issues.
24 Q: As someone, and you are responsible for the programme at the moment,
25 does the current state of affairs whereby as at the year 2000 it is not possible
26 to carry out exercises which are recognised internationally as being essential
27 exercises to test the effectiveness of a screening programme and to identify
1 failures within the screening programme are not available, does that suggest
2 to you that perhaps since the programme’s commencement no-one has
3 actually sat down and thought through the implementational aspect of this
4 part of the programme?
5 A: Sorry, you are saying we are 10 years on from the establishment and we
6 are facing the –
7 Q: You are still facing these problems. Does that indicate to you that no-
8 one had thought about the implementational aspects of carrying out these
9 important monitoring and evaluation exercises until just recently?
10 A: well, it seems it would have to, because I think if you set down on a
11 course to do it you would have – unless people had been completely
12 unaware of the legislation I suppose and just proceeded inadvertently
13 breaking the law, I guess, and that could have happened, but I think if people
14 had been cognisant of the law then –
15 Q: The issue would have come to light before now?
16 A: Yeah.
17 Q: And if people were just doing it automatically without realising what
18 they were doing in terms of the legal position, you would expect to find
19 some record of the data and the analysis of it would you not?
20 A: Yes, I would.
21 Q: And there isn't any record like that is there?
22 A: Not that I've seen, no. Not a full audit of screening histories of women
23 with invasive cancer.
24 Q: There are a series of things that Dr Cox said which I would like to get
25 your opinion on. Firstly, at p2492, he said that “one of the commonest
26 mistakes regarding reporting rates was to look at % of smears rather than %
27 of women”. Do you agree with that?
1 A: Yes, I do. I think we've been guilty of it ourselves.
2 Q: Yes, and the next point, when talking about the statistical reports –
3 that’s the first and the second statistical reports, pB2494, Dr Cox
4 commented on what he saw was a wide variability in laboratory reporting
5 and he said he was disappointed that nothing was done about that in terms of
6 it being recognised and a follow-up in the second statistical report. Do you
7 intend someone in your team to be responsible for reading the statistical
8 information and recognising issues such as this and taking steps to do
9 something about it?
10 A: I'm just – yes, I do. I'm just thinking how much – the issue, if you're an
11 operational person with the statistical report, is that it’s given you a global
12 figure so you don’t know where to go. I mean, it’s telling you perhaps, say
13 there's a big variability in the community laboratories, but it’s not telling you
14 which community laboratory or whether -. What I would be looking for in
15 our monitoring reports is that similar information is produced but down to a
16 laboratory level and therefore you can actually follow it up because you
17 know where to go to follow it up. But with the statistical report it’s
18 showing you something at a national level which may be of concern but you
19 needed it at a much more detailed level to actually follow it up sensibly. In
20 my view, anyway.
21 Q: At p2947 Dr Cox said that he saw a need for a higher level of quality
22 assurance in screening programmes and he saw this as an ethical issue
23 because, to him, there was a different ethical responsibility to persons on
24 screening programmes than to persons who were unwell and receiving
25 treatment. Do you agree or disagree with that view?
26 A: I agree with it.
27 Q: The next thing I wanted to ask you about was the European guidelines.
1 A: Yes.
2 Q: I can make sense of them so I like them, you see. Now the first thing I
3 noted about the European guidelines, Cox exhibit 44.
4 A: The tables at the back?
5 Q: If you go to the text first, 1.4, the pages aren't numbered, but if you go
6 to 1.4 part way in it says “Aim of the document” and part way down the next
7 section describes the monitoring of the programme in terms of essential data
8 necessary to evaluate effective screening both in short and long term.
9 A: Yes.
10 Q: Do you agree that data is needed if you are going to monitor a
11 programme and to be able to evaluate a programme effectively?
12 A: Yes, I do.
13 Q: I didn't realise that until I read the European guidelines, you see, that’s
14 why I like them. I think I will go to the tables now and I took both Dr Cox
15 and Professor Skegg through these tables one by one. The first one is table
16 1, which is coverage within a screening year and it just sets out women with
17 at least 1 smear mid-population %. What is your view on that table, do you
18 agree with Dr Cox or not?
19 A: Yes, I do.
20 Q: thank you. Table 2, interval to reporting, do you agree with Dr Cox it
21 would be helpful to have that table?
22 A: Yes, I do. I presume that’s meaning turnaround time?
23 Q: Yes, that’s what it is. Dr Cox said that he hadn't seen table 2 being
24 done here.
25 A: Yes. It’s one of our monitoring indicators.
26 Q: So you are going to do that?
27 A: Yes.
1 Q: Are you going to do table 1?
2 A: Yes.
3 Q: I will just tick them as I go. Table 3, proportion of unsatisfactory
4 smears, Dr Cox thought that would be a good thing, he thought that would
5 be helpful that's at 2511. What is your view of that and do you do it at the
6 moment or are you intending to do it?
7 A: Yes can I just find the indicator to see if it's identical. Yes we are
8 going to do that.
10 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
11 PROFESSOR DUGGAN: Dr Peters do you appreciate that this is
12 stratified by smear result.
13 A: Yes I do appreciate that.
14 Q: And is that what you propose to do in your indicator?
15 A: The problem is that the indicators got slightly changed at the meeting
16 last Fri and I haven’t got the updated version with me but I don’t think it is
17 stratified by a result like that and surprisingly Dr Cox didn’t mention that at
18 the meeting.
20 CHAIR INTERJECTS AND XXN WITNESS
21 CHAIR: Do you think it should be or not.
22 A: Well obviously someone with considerable expertise has designed
23 this table who I would imagine knows more about it than I do so there must
24 be a good reason for it so yes I would agree with it.
26 PROFESSOR DUGAN INTERJECTS AND XXN WITNESS
1 PROFESSOR DUGGAN: Just out of interest, if I can actually say
2 something about pathology, which is the very high rate of unsatisfactory
3 smears in women with invasive cancer which is a very important teaching
6 CHAIR INTERJECTS AND XXN WITNESS
7 CHAIR: I note that about table 3, between page 2511 and over the page
8 to 2512, after Dr Duggan had questioned Dr Cox about this matter I
9 interjected and said, do we breakdown the information in this way and if not
10 do you think we should and Dr Cox’s response was I think we should and
11 we could. What’s your view?
12 A: Well it certainly appears that we should and I can’t see any reason
13 why we couldn’t except for the invasive cancer - I mean there should be no
14 reason why we couldn’t.
15 Q: At the moment are you concerned that you might not be able to have
16 invasive cancer in a table such as table 3 because of some legal
18 A: No it would be more ensuring that both registers were up to date at
19 the same time.
20 Q: Actually I wanted to ask you about that because earlier today you said
21 something about the Cancer Register you only having information to 1995.
22 Did I hear you correct?
23 A: My understanding is that when we wanted to get the data for the 96-
24 98 statistical report we couldn’t get incidence data beyond 95.
25 Q: What do you think of that not being able to get cancer incidence data
26 beyond 1995 when you’re trying to do a statistical repot in the year 2000 for
27 the years 1996-1998?
1 A: Well it just – well it means your two registers are out of synch
2 obviously and therefore you’re not really relating what's happening in the
3 screening programme at the moment to incidence and mortality and that's a
4 problem. It also means that there are some analysis that you can’t do and
5 we’ll probably come to some of those.
6 Q: Do you thin that is a satisfactory state of affairs that in the year 2000,
7 the most recent data you get from the Cancer Register is up to the year
9 A: It was 1999 and no I don’t.
10 Q: Will you be in a position to do anything about that. As programme
11 manager can you say it is not possible for me to complete the statistical
12 information I need to ensure this programme is appropriately monitored and
13 evaluated on a regular basis if the Cancer Register is as far behind as it is?
14 A: I wouldn’t be in a position to change it. I could state the fact that it is
15 a difficulty for us but there is nothing I can do to change it.
16 Q: Are you able to push for change from within your organisation and
17 can you go to the senior manager about you and say this state of affairs is not
18 satisfactory, what can be done about it?
19 A: Yes I can do that.
20 Q: If, as has been suggested by Mrs Marshall and Dr Cox, there is a
21 cancer unit set up with all the screening programmes within it, with the
22 Cancer Register, would that be likely to lead to an improvement if
23 essentially information which it seems to me that screening programme
24 needs an up to date Cancer Register, if it were all housed in one unit would
25 that be better?
26 A: Well it's only better if a unit is adequately funded and resourced,
27 presumably – I mean I don’t know, I have no knowledge of the issues that
1 the Cancer Register faces. They may be facing problems such as a delay in
2 medical practitioners sending them notification so with all the funding in the
3 world may make no difference to their situation or they may have all the
4 reports there but have a resourcing problem themselves which makes data
5 entry slow, so without knowledge of what the problem is it's difficult for me
6 to say whether citing it somewhere else would actually make the difference.
7 Q: Ultimately if medical practitioners were slow in sending in
8 information which was seen as being essential information, would the
9 Ministry of Health be in a position to in some way tag the health benefits
10 medical practitioners receive by saying well in return you must do certain
11 things including supply us with this information within a regular time frame?
12 A: Well I think it's already a legal obligation to supply it within 21
13 working days.
14 Q: So it just needs someone to take control of the issue and ensure that
15 the legal obligation is being met if there is a delay in that respect?
16 A: Yes or an exploration of what the problems are.
17 Q: We move now to table 4 which is follow up compliance for abnormal
18 smears. Again Dr Cox thought that would be helpful and his view was that
19 he didn’t think that it was done. He said he had included it as a template in
20 the first statistical report thinking that it would be filled in later but it wasn’t
21 it was dropped from the second report.
22 A: I think the only way we have of measuring that at the moment is
23 ensuring that we’ve received a histology report so I’m just trying to find the
24 indicator that we have –
25 Q: What would actually be a helpful exercise, we have got too far into
26 this, if we go back to table 1, if you could tell me what indicator in your
27 document matches table 1 and I can write them in.
1 A: It's page 3 of 27.
2 Q: Right and table 2.
3 A: It would be I think 15 of 27. No, it’s not. It’s p16 of 27.
4 Q: And table 3, is that in the indicators at the moment, or even partially?
5 A: It’s 17. No, I need to check the page. We seem to have it slightly
6 wrong. Yes, its 17 of 27.
7 Q: Table 4, I think you gave me that before, did you say it was indicator 8?
8 A: No, and I have to say some of the definitions did change a little bit, but
9 not really the substance I guess. It’s actually follow-up of women with high
10 grades and it’s p8 of 27.
11 Q: Table 5, follow-up compliance for women with at least one abnormal
12 smear. Dr Cox, when asked if that was necessary, said yes, absolutely.
13 A: Yes, I think we discussed that on Friday. I'm having trouble
14 remembering where we got to.
15 Q: Do you have it at the moment, the document?
16 A: No, so I don’t think we do.
17 Q: Table 6, time compliance number of women by most severe diagnosis
18 within a given screening round.
19 A: Well that would be cytological abnormality/1,000 women. And we did
20 decide that we would be doing that.
21 Q: So it’s not in at the moment but you will be doing it?
22 A: Yes.
23 Q: Table 7, this was another table that Dr Cox thought we should be doing.
24 That’s treatment compliance. Do you intend to do that at the moment in
25 your indicators?
1 A: I don’t know that we actually could do that at the moment because we
2 don’t collect any treatment data on the Cervical Screening Register. So until
3 we are collecting colposcopy and treatment data it’s not possible.
4 Q: Do you think it would be a good thing to do in principle?
5 A: Yes, I do.
6 Q: What is stopping you from doing it at the moment? I know you’ve said
7 you need to collect certain data such as colposcopy data, but why aren't you
8 able to do that at the moment and when will you be able to do it if you think
9 it’s a good idea?
10 A: Firstly, you would have to define a colposcopy and treatment data set
11 and get agreement among the professionals on the data elements and I've
12 been through that with breast screening and I know it takes a long time, and
13 then we would have to ensure that all the HHSs at least were able to either
14 collect the information electronically or were prepared to fill it in manually,
15 and of course we couldn't enforce that on private gynaecologists but we
16 could seek their co-operation through the College. And then we would need
17 to alter the Register to ensure that the Register – we would need to modify
18 our own information system to collect it.
19 Q: Is it something that you would consider worth doing in the future?
20 A: Yes, it is.
21 Q: Table 8, smear sensitivity for detection of invasive cervical cancer. Dr
22 Cox said to his knowledge there was no way of measuring smear sensitivity
23 at the moment or programme sensitivity.
24 A: We certainly agreed that we would calculate programme sensitivity.
25 Q: Is that in the indicators at the moment?
26 A: Yes, it’s 14 of 27.
1 Q: Table 9, distribution of incidence cases, invasive cervical cancer cases
2 by stage. Is that done at the moment?
3 A: No, it’s not done at the moment. We certainly agreed this was
4 something we were going to make a special effort to collect information
5 from clinicians on staging. We were going to approach the Cancer Register
6 about that and that would be – no.
7 Q: How will you get it done, because I see Dr Cox had said that “we don’t
8 collect the infant stage information nationally either at Cancer Registry or
9 through the programme.” And he said “At the moment it would probably
10 require a special reporting form from the gynaecologists or oncologists who
11 were treating patients. How would you get them to do that?
12 A: I think we’re talking here, in our indicators of 11 out of 27, early
13 detection. Well, at the meeting we agreed that we would pursue this, and
14 there were two gynaecologists there who seemed – one representing the
16 Q: Table 10 distribution of incidence cases, invasive cervical cancer cases
17 by detection. Do you agree that that would be good information to have and
18 have you made provision for it at the moment in the indicators? This is one
19 that Dr Cox said would mean collecting data from women who are not in the
20 programme as well as those who are.
21 A: No, we haven't.
22 Q: The next one, table 11, interval cancers, incidence of invasive cervical
23 cancer by time since last normal smears. This is one that Dr Cox said
24 information was not collected at the moment and it was vital. What is your
25 view of table 11 and do you intend to make provision for it in the indicators?
26 A: Well, I think it’s important. This is one Dr Cox said we would need
27 extra information for, did he?
1 Q: No, that was 10. Table 11, I will read what he said.
2 A: Oh, interval cancers, yes we have got that actually.
3 Q: When I asked “was the information collected”, he said, “no we don’t,
4 and it’s vital”, and when I said “for what purpose”, he said, “for the
5 calculation of sensitivity of the programme you need to know the interval
6 cancers and the number of them.”
7 A: Hmm. For us that’s 13 of 27. I do want to stress that some of these
8 definitions were refined and altered at the meeting on Fri. Probably not
9 worth providing the updated until submissions because they won’t be
10 complete until then.
11 Q: That's alright as long as I know which ones are being adopted. Table
12 12 interval cancers re-evaluation of previous smears.
13 A: I think we’ve got that in the quality standards that that would need to
14 be undertaken at a laboratory level but I’m not sure that we’ve got it as part
15 of our overall monitoring plan at the moment, I don’t think we have but we
16 would expect laboratories to keep a record of this.
17 Q: Table 13 which is this one consumption of smears.
19 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
20 PROFESSOR DUGGAN: Dr Peters could you just repeat that for
21 me. Is the requirements on laboratories to re-screen the smears on women to
22 develop cancer while their on the programme.
23 A: To review them yes I think there is.
24 Q: In the interval when a woman develops cancer.
25 A: Oh I see what you’re saying. Actually they couldn’t do that unless
26 they were aware of it.
1 Q: I’m thinking of Mr Jones evidence. He was advocating that this be
2 done on every case as he’s managing it which would suggest that it's not
3 being done routinely.
4 A: I thought he was talking of a full audit of the whole case of the
6 Q: That plus a relook at the negative smears if there were any. I think
7 that needs to be clarified.
9 CHAIR INTERJECTS AND XXN WITNESS
10 CHAIR: Why aren’t you including table 12 in your indicators because
11 it's something that Dr Cox said when I reached table 12 he said we’re
12 starting to get into some of the, if you like, audit side of things and that's
13 vital. And when asked do we have it he said no we don’t and he went on to
14 say how necessary it was so why aren’t you doing it?
15 A: I think it is in the quality standards but I don’t know that we have –
17 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
18 PROFESSOR DUGGAN: In the quality standards you have the look
19 back on negative smears on somebody who has a high grade.
20 A: Right I see what you’re saying. We need to take the interval cancers
21 from the Cancer Register so – I mean this involves looking at all the women,
22 all the incidence of cancer say in a year and we’re only interested in this case
23 in women who have being diagnosed with cancer in the past three years
24 since that is our screening interval. Well I think it's a very important thing.
25 The thing you’ve got to – we could only do it for women on the programme,
26 we couldn’t do it for women who weren’t enrolled. I’ve just got to think if
27 there’s any obstacle with Section 74A because it would mean us – I would
1 really have to think about it. I agree that it's important I’m just not sure it
2 can be done and who would do it.
4 CHAIR INTERJECTS AND XXN WITNESS
5 CHAIR: Do you think in principal that it would be better to have all the
6 information contemplated by the tables we’ve looked at so far including
7 table 12 and beyond all in the one document?
8 A: All in one annual or quarterly monitoring report?
9 Q: Yes.
10 A: Yes.
11 Q: It makes it more difficult if to get the information in table 12 you
12 have to go elsewhere, in fact my understanding of your evidence is you’d
13 been relying on laboratories to carry out this exercise.
14 A: Well actually that was a mistake. I’m thinking here that to do this,
15 and I do need to think through the practical applications, that we would need
16 to be obtaining the names of women who have developed cancer from the
17 Cancer Register, who are enrolled in the programme and have developed
18 that cancer within the last 3 years and then we would need to be providing
19 that information plus their screening histories to an outside body which is
20 going to collect their smears and reread them and that would have to be
21 some kind of independent process. Now I haven’t explored how that would
22 be set up but that would involve pathologists. I think it's important. I think
23 to be honest I have to say we are not at that point at the moment.
24 Q: If you did have it built in to your programme, would it be an effective
25 way of picking up under-reporting?
26 A: It would certainly give you a clear indication yes, that you may have a
1 Q: We’ll move on to table 13 consumption of smears. What comment
2 do you have about that?
3 A: Well I think that's useful to know how many smears women are
4 having and whether – I guess it's whether you do it just for women who have
5 a normal screening history because women with an abnormal history will
6 have a greater consumption if you like but yes I think its useful.
7 Q: And are you planning to do it at the moment?
8 A: I’m not sure that we are but it's quite an easy calculation to do.
9 Q: I just want to be sure what is planned to be done.
10 A: No I don’t think we had that indicator.
11 Q: Table 14 distribution of smears, % of women with more than one
12 smear. Is that something that you’re planning to do and do you think it
13 would be a good thing to do?
14 A: I think we’re doing some indicators which may be related but not
15 identical. One is short interval re-screening and the other is delayed re-
16 screening so we discussed at our meeting whether we would do the analysis
17 as is suggested in the guidelines or whether we would use our indicators and
18 the consensus was to use the short interval and delayed re-screening
19 indicators which are our –
20 Q: Table 15.
21 A: That's page 5 of 27 and 7 of 27.
22 Q: That's of table 14.
23 A: 14 & 15.
24 Q: So 14 is 5 of 27 and 15 is –
25 A: well there not identical, there related. 5 of 27 and 7 of 27.
26 Q: Table 16.
1 A: And we may have decided to do it as well for women with abnormal
2 screening histories but I’d have to wait until I get the notes. Table 16, no I
3 don’t think we have that indicator.
4 Q: Do you think it would be useful to have?
5 A: I’m not sure because I would have to think of the value I would add
6 and I’d just be thinking on my feet and it doesn’t always go very well.
7 Q: Table 17, incidence of invasive cervical cancer before and after the
8 start of the organised screening programme. Will you have that
10 A: Incidence we have at 9 of 27. I don’t know whether we were going to
11 do the time period analysis, but we certainly were going to do incidence.
12 Q: And table 18, mortality?
13 A: Yes, we've got that as 10 of 27, and it would be a 3 year rolling average.
14 Q: Now I understand from you that at the moment the indicators are not in
15 place, they are still being worked on, and when I went through these tables
16 with Dr Cox I was asking him is it being done at this very moment and he
17 was giving me answers. Do I need to go through that with you as well or is
18 it likely that what he said would be reasonably well informed?
19 A: I think it would be reasonably well informed.
20 Q: Overall, do you think that the European guidelines provide a helpful
21 benchmark for information of a type that’s necessary to look at the quality
22 assurance of a Cervical Screening Programme?
23 A: Yes, I do. They are certainly one of the resources we've used to design
24 our indicators, but we do have some additional indicators which are not
25 covered in here.
26 Q: I've spoken to Dr Duncan about the need for a red flag so that at a
27 certain point in time you would recognise that what you were being
1 presented with wasn’t the usual false negative but in fact misread smears.
2 And I noted in the Sigerdsen article which Dr Cox put forward, which is
3 exhibit 45, which is just underneath the European guidelines, p733, part way
4 down the page, it said: “The incidence of invasive disease after a negative
5 smear reflects both a sensitivity of the test and after excluding the false
6 negative cases (those with only 1 negative smear prior to diagnosis), and it
7 goes on. What I wanted to know from you was whether or not you are
8 developing some sort of protocol whereby you would say that X number of
9 cases where there was more than 1 negative smear prior to diagnosis would
10 be seen as a red flag that something further needed looking into.
11 A: I think to be honest we haven't got to that. But I agree, it’s important
12 to have protocols so that you know when you’ve got – well, when you might
13 have a problem that needs to be investigated.
15 PROFESSOR DUGGAN: Do you understand that para in the Segerdsen
17 A: At this stage of the day I’d probably need to take it away and think
18 about it, but I mean I would need to think about the para. I’m sure I would
19 understand it if I thought about it, but just to take that sentence in in 2
20 minutes I would need to think of the calculations in my head.
22 CHAIR: Can I just ask you, though, as a rule of thumb do you think that
23 using as a rough guide a certain number of cases where there had been a
24 series of negative smears in reasonably close sequence to a diagnosis of
25 cancer could be used as a red flag, that this was more than the usual false
26 negatives that one associates with laboratories?
1 A: well, it could be used as a red flag but it wouldn't necessarily be, if the
2 women had a false negative because she already had invasive cancer then it
3 may not be a laboratory false negative it might be that she should have been
4 referred immediately. So it may be a red flag that there's something wrong
5 in the screening programme but not necessarily the laboratory.
6 Thank you.
8 PROFESSOR DUGGAN: You have, based on all the documents you have
9 provided, obviously been engaged in a very extensive review of the literature
10 on cervical cancer screening programmes and laboratories, colposcopy etc.
11 In all of your reading have you come across a definition of a failure of a
12 screening programme?
13 A: Well I think I’d better preface my remarks by saying I won't have read
14 as extensively as the people who've been doing the work for me because I'm
15 managing a team as well as trying to absorb technical information. So can
16 you just ask me the question again?
17 Q: Based on the information provided you by the people who are doing the
18 evidence-based research, has there been in any of that literature an approach
19 to determining what a screening programme failure is or a screening
20 programme indicator of possible failure? Or is this something new. Is the
21 question that we’re asking something new that’s not defined anywhere else
22 in the literature?
23 A: I don’t know. It hasn’t been presented to me by the people who've been
24 doing the work for me, but then that doesn't say it doesn't exist because they
25 may not have been looking for it.
1 CHAIR: if you could then turn to the next exhibit, a bulletin of the World
2 Health Organisation in 1986, and this is Cox exhibit 46. It’s control of
3 cancer of the cervix uteri, and if you would look, please, at p611, the right
4 hand side there is a heading “impediments to screening” and third para down
5 it says “Deficiencies in record keeping in cytology laboratories and Cancer
6 Registries make the administration monitoring and evaluation of activities
7 very difficult, if not impossible”, and this is given as one of the impediments
8 to screening. As the person ion charge of the unit who’s responsible for the
9 programme, given that there is literature from 1986 stating this, what is your
10 view on the current state of the Cancer Registry information available to you
11 and information generally which is currently available to you to be able to
12 monitor and evaluate the programme?
13 A: Well I think the information that’s on the Cervical Screening Register,
14 presuming the quality is all right, is actually quite good. The Cancer
15 Register has obviously been brought up-to-date this year and I don’t know
16 whether some of the underlying problems of previous delays have been
17 addressed, and presuming they have been, then we may not have great
18 difficulties in the future. I don’t think I can really comment on the record
19 keeping in cytology laboratories because I haven't explored that, but one of
20 the exercises we would want to go through with implementation of the
21 quality standards would be how records are kept and how things will be
23 Q: And is it the case that if the Cancer Registry is not working effectively,
24 that in turn will – put it this way: If there are deficiencies in the Cancer
25 Register that will make it difficult for you to carry out the monitoring and
26 evaluation of part of the screening programme, is that correct?
27 A: Yes, it would make some of those analyses impossible.
1 Q: And from the perspective of the programme, given that you’ve told me
2 that in 1999 the information you got from the Cancer Register was only up
3 until 1995, do you think it needs to be improved in terms of the timeliness
4 and the availability of information for later years.
5 A: Well for example to provide information in the quality and the
6 monitoring report on the staging of incident cancers for the calendar year
7 that has just passed, you couldn’t do that if you don’t have the names on the
8 Cancer Register so that even if they’re not collecting the information you
9 can go to gynecologists and request it so it really would be a problem.
10 Q: So if you want to ensure that the screening programme is going to be
11 able to be monitored and evaluated at a level which you would be happy
12 with, do you thin that there needs to be an upgrading of the Cancer Register
13 or will it do the job as it is?
14 A: The difficulty I have is that I don’t know what their issues are, I have
15 no idea -
16 Q: I know you don’t know and we’re not being critical of them I’m just
17 trying to get a clear understanding of do you need it to be upgraded in order
18 for the screening programme to function as effectively as you would like it
19 to in respect of monitoring and evaluation.
20 A: Yes.
21 Q: Thank you. Could you just, just to help me put a year on when you
22 would like the information up to date by, in other words, to work effectively
23 is it feasible if the register were up and running properly to have information
24 for the year 1999, 1998?
25 A: If you were wanting to do – I mean most of our analysis, some would
26 be done quarterly but all would be done annually so I suppose that you
1 would want by say March 2001 in an ideal world to have all the information
2 in for the year 2000.
3 Q: Could you look please at page 613 of this article which is dealing
4 with cytology laboratory organisation and quality control and just read all of
5 the first paragraph and part of the second paragraph down to where it is
6 talking about needing help to maintain the cytotechnologist skills.
7 A: Yes.
8 Q: Do you agree with those views?
9 A: Well you’re asking me whether we should centralise all our
10 laboratories, our cytology services. I think as a general principal yes I do
12 Q: If you could turn please to page 614 bottom right hand corner under
13 the heading evaluation which starts the cervical cancer control programme
14 should not be initiated prior to the establishment of adequate evaluation
15 procedures and it then goes on to set out what should be done. If you could
16 just read over the page then read the matters listed there as being matters to
17 be considered when evaluation the programme.
18 A: Yes.
19 Q: Do you agree with the statements expressed there?
20 A: Yes I do.
21 Q: If you would look please at page 615 down the bottom left hand
22 corner where the sentence begins in order to determine the effect of a
23 screening programme it's necessary that data and it lists a number of things
24 over to the top of page 651 the end of the paragraph, if you would read that
25 and tell me whether you agree with it or not.
1 A: Yes I think that's important although it might be difficult before a
2 screening programme begins to have data on the frequency of screening
3 because you’ve got no data collection system.
4 Q: The next paragraph where it says screening programmes can be
5 evaluated by their failures and then it lists ways in which to do that, if you
6 would just read that paragraph please and tell me whether you agree with
7 that or not.
8 A: Yes I agree with that.
9 Q: Thank you. Just for completeness if you go to the next document
10 which is another World Health managerial guidelines it's Cox 47 and just go
11 please to page 40 and look at the paragraph headed policy issues and use of
12 data and tell me whether or not in principal you agree with that.
13 A: Seems very sound to me.
14 Q: Over at page 41 under the heading monitoring and evaluation could
15 you just read that down toward the bullet points and tell me if you agree with
17 A: Yes I do.
18 Q: And then over the page, page 42 heading data requirements for
19 efficient programme evaluation and there's a series of bullet points could
20 you just read that and tell me if you agree with that or not.
21 A: In general I agree with it. I don’t know whether a separate Register
22 of all abnormal smears but I can see, that's like collecting colposcopy data,
23 I’m not sure you need a separate Register but I do think you need the
25 Q: And just finally on this document the next paragraph down starting
26 for evaluation and monitoring purposes if you would just read that and tell
27 me whether or not you agree with that.
2 A: Well the issue with that para is that it’s referring to a population
3 database so that you can identify and invite women, which we don’t have. I
4 mean, I agree with the principles.
5 Q: And I note at p28, talking about monitoring there, it said efficient
6 monitoring requires a system of linked records, a population register or
7 available substitute, a cytology register, and it says when linked with a
8 Cancer Register?
9 A: Hmm.
10 Q: If you would just read that para, please, and tell me whether in principle
11 you agree with that.
12 A: I agree that the efficient monitoring requires a system of linked records.
13 And I agree that a population register allows periodic call back for re-
14 screening at appropriate intervals. So I basically agree with the principles
15 but we don’t have a population register. Therefore, we have limited ability
16 to determine information about the groups missed in the target population.
17 Q: Do you think we should be moving towards having a population
19 A: Well I think to be pure in the design of screening programmes that
20 would be the ideal. I think that in the absence of that, and I don’t know
21 whether – I mean I certainly noticed in the UK that they didn't seem to need
22 to invest nearly as much – or they didn't invest nearly as much – in health
23 promotion and recruitment activities as we do, for example, with our breast
24 screening programme because we can't invite people directly, we have to
25 have a media recruitment campaign. That creates a problem because you
26 can't be running advertising all the time. So there are a lot of benefits that
27 would accrue from a population based register. However, I don’t think one
1 should think that it would completely remove the need for good recruitment
2 and health promotion because we still really need to inform women about
3 what screening programmes are so that they can make an informed decision
4 about participation.
5 Q: Do you think, ideally, putting aside legal obstacles, we should have a
6 linked cancer cytology register?
7 A: Well, I'm not quite sure what linkage would mean. I think at certain
8 times of the year you need, or at least annually you need to be able to link
9 your information.
10 Q: Do you do that at the moment?
11 A: No, we don’t.
12 Q: Are you – by you I mean the Health Funding Authority itself, hampered
13 by 74A? I’m just trying to get a sense of how far this section’s influence
15 A: Well, I haven't sought legal advice on that myself, but if I just think
16 through the issues, it seems to me that - I think we would be – I think we
17 could obtain information from the Cancer Register, identifiable information
18 possibly, I don’t see why we shouldn't be able to do that because obtaining
19 that information would be one of the purposes for which it was collected, we
20 were wanting to find out more about cancer and we could link it to records
21 on the Cervical Screening Register, but I don’t think that we, without
22 women’s consent, could then go and obtain their clinical records with any
23 more freedom than anyone else, or their slides.
24 Q: If you could look please at p27, there is some text on monitoring and
25 evaluation, if you could just read through those 3 paras and say whether or
26 not in principle you agree with that.
27 A: Yes, I do.
1 Q: the next thing I want to do is move to the role of the national co-
2 ordinator because Dr Cox pointed out in his evidence that you were manager
3 of the unit within which the Cervical Screening Programme is housed but
4 that there was a national co-ordinator. I just wanted to get an idea now of
5 how the national co-ordinator’s role related to your role and who was seen as
6 having leading responsibility for the programme now?
7 A: Well, I think I would probably be seen as the person with leading
9 Q: the other thing is, I don’t know whether I did ask you this before but I
10 will again: both Dr Cox and Mrs Marshall said there was a need to keep the
11 programme out of the Ministry of Health and the impression I got was that
12 view was based on their own earlier experiences while the programme was
13 with the Ministry of Health, and I know Mrs Marshall said she thought the
14 programme had fared better with the Health Funding Authority. If you had
15 the choice would you rather see the programme within the Ministry of
16 Health or a stand alone unit with a sort of cancer control unit that Dr Cox
17 and Mrs Marshall have talked about where all the screening programmes and
18 the registers, including the Cancer Register are located?
19 A: Well, putting aside my own personal preferences because it seems a
20 little irrelevant, I think a major upheaval now – I mean, I guess it really
21 depends how, in a sense, people think things should be managed in the
22 future. But I believe what we need to do in NZ is build up expertise in the
23 management of screening programmes in-house, not relying on external
24 people. I mean, we do need external experts because, as I've pointed out,
25 we won't have a cancer epidemiologist in our unit, but my own feeling, this
26 is just my professional view, that there’s been an over reliance on external
27 experts and insufficient attention to developing the expertise within the
1 system to manage the programme or programmes and while I don’t think
2 what we have in place at the moment is ideal, I think we need more people
3 with more expertise, I think we’ve developed quite a lot of expertise so I
4 think that unless there’s a view that there’s a need for a major upheaval at
5 the moment, by far my preference would be to consolidate what we have
6 started rather than start another restructuring and moving into another
8 Q: Do you think that you will get the support that you need from the
9 Ministry of Health in order to implement all the hard work that you have
10 done in the draft documents you’ve put before the committee in exhibits 40,
11 42 and 47?
12 A: Well all the indications are that I will.
13 Q: I’ve said this because the issue that you’ve made about the use of
14 outside experts and the over reliance in that is something that is brought out
15 in CSAC’s report of Oct 93 which is in Glackin 7 I think. Yes Glackin 7 tab
16 35 it's Oct 94 at page 40 in the top right hand corner and you’ll see there that
17 they are talking about, this is under the guise of barriers to effective
18 monitoring and evaluation but they talk about the WHO requirements, the
19 need for a central office and an individual who is responsible for planning,
20 coordinating, monitoring and evaluating. They then set out their concerns
21 about fragmentation that has occurred as a consequence of the health
22 reforms. They then talk about the difficulty, this is the forth paragraph,
23 recruiting and retaining permanent staff with appropriate expertise in fields
24 of public health epidemiologist and they then say although expertise can be
25 contracted from outside the unit for specific projects in house personnel are
26 required for routine monitoring, to compile performance measures, identify
27 when they are unsatisfactory and alert the person with overall responsibility
1 who will then be able to take appropriate action. The availability of
2 expertise predominantly through advisory groups rather than through
3 salaried appointments by the programme does not adequately fulfill this need
4 and then they talk in summary about the need for good operational
5 leadership for the public health perspective so given that, the comments
6 similar to the comments you have made today were being voiced by CSAC
7 in Oct 94 and they don’t appear to have been acted on then, do you have
8 concerns about the Ministry accepting the plans that you now have to make
9 the programme effective to the point where you’re able to fully implement
11 A: I’m struggling. Firstly I’m not sure that recruiting staff is any easier
12 depending on which organisation is managing because I have tried recruiting
13 and it's – you don’t necessarily get the applicants that you want and there
14 appears to be a shortage of epidemiologists and public health medicine
15 specialists in New Zealand.
16 Q: It was more the comments there on the reliance on advisory groups.
17 A: I mean really all I can say is that I have had through my manager a
18 commitment from the Director General that she wants to ensure that it's put
19 right and that the necessary resources are made available to ensure that
20 things aren’t put right. She doesn’t want to leap to solutions in terms of
21 staffing, she wants to consider it carefully. It seems a positive response
22 which would give one confidence and I don’t really feel I can comment any
23 further than that having never worked in the Ministry or experienced those
25 Q: Tell me, the Ministry in it's new form with the Health Funding
26 Authority as part of it, is it still going to be a policy organisation or will it
27 have an operational role as well?
1 A: I don’t actually think that's probably fully determined. I mean
2 certainly initially it's going to have an extensive operational role. But I think
3 ultimately how operational it may remain will depend on the extent of
4 devolution that occurs and I don’t think that's clear.
6 MR MURRAY ADDRESSES CHAIR
7 MR MURRAY: Madam Chair I hesitate to interrupt but I think the bill
8 that's going to actual create the structures is about to be introduced to the
9 House shortly and I just think Dr Peters is really struggling to anticipate
10 what those structures will be until we see the Bill.
11 CHAIR: Very well.
13 MR GRIEVE ADDRESSES CHAIR
14 MR GRIEVE: Madam Chair while we’re on interruptions, it seems to
15 me that from this witnesses evidence and indeed in other respects, we know
16 clearly that the buck stops on the desk of the Director General and I know I
17 may incur your wroth but in my submission it is she who should be
18 requested to attend to answer the crucial question that you have asked.
19 CHAIR: This is what comes of giving you two subpoenas today you
20 want a third.
21 MR GRIEVE: I’m not volunteering to issue the subpoenas.
22 CHAIR: It's a very difficult application to make at 5:45. I was coming
23 to the end of my questioning, let me complete Dr Peters and then we’ll deal
24 with your application.
25 MR GRIEVE: Possible application.
27 CHAIR CONTINUES XXN OF WITNESS
1 CHAIR: Dr Peters one of the matters that I raised with Mrs Marshall
2 was the issue that perhaps the Ministry of Health in earlier times when it
3 had the programme within it given that it's role was more, or was a policy
4 role, that it may therefore not have been attuned to what needed to be done
5 in an operational sense to get the programme going. If that did have a
6 detrimental effect on the programme and I haven’t asked any of the Ministry
7 of Health officials that question yet but if it did, is there a risk do you think
8 that that could occur again?
9 A: So if the Ministry was – we’re speculating really – if the Ministry was
11 Q: It's a hypothetical question.
12 A: - was very much a policy agency and yet this requires a very
13 operational focus.
14 Q: Yes.
15 A: Well it would be a mismatch. I think one of the things I definitely
16 agree with Mrs Marshall on is that probably everybody’s learnt a lot and it's
17 another thing I would want to emphasise that I think probably even in my
18 own organisation there’s a failure to appreciate and because the screening
19 programmes are actually tiny in budgetary terms, the complexity on
20 embarking on something like this and the fact that it's so resource intensive
21 and to do it right, every step has to be right, data entry has to be right,
22 reading smears has to be right, breast screening read the mammogram, but
23 you can have a failure at any point if the whole system isn’t working and
24 ensuring that and dealing with the issues which arise from that on a day to
25 day basis I mean I just know that we are so busy managing these
26 programmes at a national level and I guess part of that is because they are
1 not in a steady state, but I just think there's an under-scoping of what it
3 Q: Do you think that has always been the case, that no-one has realised the
4 full scope of what is entailed in running a screening programme
6 A: I suspect a scoping exercise has never been done.
7 Q: What is a scoping exercise?
8 A: Well, an assessment of what the roles are, what the tasks are, and what
9 workforce is going to be required.
10 Q: I noted in the European guidelines there was a reference there to
11 statistical information of an economic sense which basically enabled you to
12 do what I would call a cost benefit analysis, in the sense that you look at the
13 cost of the programme but then you are able to measure that against the cost
14 in terms of the lives that are gained as a result of having a successful
15 programme and perhaps also you take into account health costs saved in
16 having a successful programme. It seemed to me that if you had such an
17 analysis it would be a good weapon in order to get good funding to maintain
18 the quality of a programme. Are you planning to have that exercise and do
19 you think it would be helpful if you did carry out such an exercise?
20 A: We certainly have thought of it but we haven't pursued it. I mean,
21 what you are saying is exactly correct because although it is relatively small
22 in budgetary terms, of course an intervention such as a successful screening
23 programme is something we know actually does save lives.
24 Q: Yes, well I think there's something about it in the European guidelines
25 which is why I like them so much – I might be wrong. I will just flick
26 through. While I’m looking for this, the last question I wanted to ask you
27 but I may have to go back to the European guidelines was, where a
1 laboratory is taken over in the way that Gisborne laboratories was, I've noted
2 from looking at the laboratory standards of 1995 that it’s an obligation to
3 maintain records for 10 years, but I wondered if the programme was going to
4 have some protocol to ensure that there was some continuity kept so that in
5 practice you would be able to carry out smear history reviews because the
6 records were being maintained by the new entity that had taken over the old
7 laboratory. Can you help me on that?
8 A: I think we've specified 14 years in the standards, or 14 and 20 years. I
9 know there's a misprint there. But no, we hadn't looked at ensuring that
10 they were transferred to the new entity, but I do agree it’s an important point,
11 Q: Do you think it’s something that you need to provide for?
12 A: Yes, I do.
13 Q: what happens, because it seemed to me when I was looking at that
14 issue, I was trying to work out, well what happens in terms of smear review
15 history when a woman moves and her smears are at different laboratories,
16 there would be no easy way of doing a smear review history then would
18 A: No, there should be no problem with accessing the slides from another
20 Q: So if you can fix that one up quite easily it would be very important, for
21 example, to make sure that if a laboratory was taken over that all the slides
22 associated with the past owner and past smear-reading of going 10 years
23 back were adequately stored and accessible for the purposes of carrying out
24 smear history review?
25 A: It would be, and also important for other laboratories to know which
26 laboratory had taken over, had those slides.
1 PROFESSOR DUGGAN: It may be that the Register would need to be
2 informed of this?
3 A: Hmm.
5 CHAIR: Well, I can't find where I saw the provision for a cost benefit
6 analysis, but you consider it would be a good thing to do?
7 A: Yes.
8 Thank you, I have no further questions. Are there any questions arising
9 from the examination? I’m sorry, I forgot something. Mrs Barrett pointed
10 it out to me. This is the duRose exhibit. I think it is 12, and the concern I
11 had about it when I read it, it seemed to be suggesting that final policy and
12 quality standards were not due until July 2001.
13 A: Yes, that’s not correct. It is something that Jim drew up. It’s not how
14 I am intending to proceed.
15 Q: Well, he told me it was his transitional plan and he was going – I will
16 use his words: “to transition it in”, which I was at a loss to understand, but
17 that’s what he said.
18 A: I think he’s been trying to assist us in – he’s developed a relationship
19 with laboratories and they do have a good relationship with him now and,
20 therefore, from the personal health side, which is important to us at the
21 moment because they still are managing the contracts and the funding, they
22 want to work with us to ensure that appropriate implementation plans are
23 drawn up with laboratories for the quality standards. I mean, I'm sure even
24 Jim would agree that this was a proposal to assist with that process but we
25 need to move it much more quickly than 2001.
1 Q: Yes, well at this table on the second page, January/June 2001, the bullet
2 point: “review overall results of the project and transition relevant aspects
3 into the programme’s monitoring and evaluation plan.”
4 A: Yes, but he's got by mid-November 2000 all the laboratories would
5 have completed a gap assessment of their key practices against the draft
6 standard – substantially meet the standards by July 2001”. I think we would
7 want to see it a little bit faster than that.
8 Q: Well it seemed to me to be in conflict with what you had told the
9 committee in terms of when the indicators in exhibit 42?
10 A: No, we’re talking about the quality standards
11 Q: And is that chapter 5?
12 A: Yes.
13 Q: But my understanding is in some ways chapter 5 of exhibit 40 gets its
14 teeth from exhibit 42, which is the benchmarks by which you measure
15 laboratory performance.
16 A: Well it gets its teeth through the contract and through actual – a majority
17 of those standards would need to be audited against.
18 Q: Yes.
19 A: I think that’s what gives them their teeth. The monitoring comes over
20 and above that and is also another means by which we go back to providers
21 regarding performance.
22 Q: Well my understanding is that in order to monitor you have to have
23 standards which you measure people’s performance against.
24 A: Yes, you do.
25 Q: And that was the purpose of exhibit 42, that gave you the standards, the
26 indicators, and you used how a laboratory measured up, in terms of those
1 indicators, to get information, firstly, to monitor them and presumably to
2 evaluate their performance?
3 A: I don’t want to get into detailed discussion. The two are linked but
4 they're not the same. Standards are about quality practices, national
5 consistency as a basis for a quality programme, and many of the standards –
6 compliance with the standards would only be able to be ascertained by audit
7 by a visit.
8 Q: Yes.
9 A: But the monitoring will certainly, well I am anticipating it will
10 indicate that we are achieving our objectives, that where there are areas that
11 we need to focus and do better and where there may be potential problems
12 that we can explore and that we need to explore and particularly with the
13 laboratory indicators we are – there may be issues at a laboratory level.
14 Q: But the standards which are in exhibit 42 my understanding is that
15 standards are a precondition of quality assurance .
16 A: I just think there an integral part of it yes.
17 Q: And I understood at some time in the future, going back to your
18 evidence yesterday, the indicators in exhibit 42 were going to be added as an
20 A: Yes they’ll either be appendix or incorporated into the chapters to
21 which they relate but some of them are, if you look at the index of the
22 indicators many are overall programmes so they –
23 Q: Well when Mr DuRose talks on the first page about the final policy
24 and quality standards July 2001 I took that to be a version of what is now in
25 draft exhibit 40 with the exhibit 42 indicators in their final form attached
26 either as an appendix or incorporated into the final version of exhibit 40 am I
27 correct in assuming that or not.
1 A: He’s referring of implementation of the policy and quality standards
2 he’s referring to exhibit 40.
3 Q: Right but if it's the final version of exhibit 40 would that not include
4 exhibit 42 in the appendix.
5 A: Yes it will.
6 Q: And can I take it from you that the final version of exhibit 40
7 including exhibit 42 as an appendix is going to happen a lot sooner than July
9 A: Yes definitely.
11 PROFESSOR DUGGAN INTERJECTS AND XXN WITNESS
12 PROFESSOR DUGGAN: Can you just clarify for me is the
13 monitoring going to be done by the monitoring group?
14 A: Yes.
15 Q: So laboratories will not be asked to do their own analysis of data.
16 A: No.
17 Q: So just to be even more specific, when we look at the histology
18 cytology correlation this is going to be done by the monitoring group for a
19 specific laboratory.
20 A: Yes.
21 Q: And the laboratory will get a copy and the programme will get a copy.
22 A: Yes they will get the whole report.
24 MR MURRAY XXN WITNESS
25 MR MURRAY: Just have very quick re-examination conscious of the
26 time. Three quick topics First you have referred Dr Peters several times to
27 your manager. Is that Dr Don Matheson?
1 A: That's correct yes.
2 Q: And is Dr Matheson a public health specialist?
3 A: Yes he is.
4 Q: And is he moving into the Ministry with you as this year progresses?
5 A: Yes he’s already moved into that.
6 Q: And what will his title be when he is there?
7 A: Deputy Director General of Public health.
8 Q: You were asked some questions about the adequacy of the Cancer
9 Register for your purposes and as the manager of the screening programme.
10 We’ve got an affidavit from Paul Cohen who is the manager of the Cancer
11 Register and I just wonder where you aware of the evidence in that affidavit
12 when you answered the questions that you did just now about that topic.
13 A: No I wasn’t.
14 Q: Mr Cohen of course would have the most up to date information
15 about the state of the Cancer Register I take it.
16 A: Yes I wouldn’t claim to have any detailed knowledge at all of the way
17 the Cancer Register works.
18 Q: Right –
20 CHAIR INTERJECTS AND XXN WITNESS
21 CHAIR: Can I just ask then how it comes to be – I mean I accept what
22 Mr Cohen says now and I’m not trying to be difficult but in terms just of the
23 freeflow of information within the Ministry and the Health Funding
24 Authority given that you are all working together in a sense now, how is it
25 that you’re not aware of what is readily available from the Cancer Register.
26 A: Well it's possibility because I haven’t explored it. I mean we
27 explored it for the statistical report last year and I was surprised that we
1 didn’t seem to be able to get more up to date information. I know that once
2 we finalise these indicators we will need to explore it again in more detail
3 but I just hadn’t got to it.
4 Q: So certainly as at last year things weren’t as good as they seem to be
5 now as set out in Mr Cohen’s affidavit?
7 MR MURRAY ADDRESSES CHAIR AND CONTINUES XXN OF
9 MR MURRAY: I think there’s a chronological issue there and Mr
10 Cohen who actually is not particularly well at the moment so it might have
11 to be a substitute but that chronological aspect that when information or how
12 up to date the Register was at certain times may have to be explored with
13 him or his substitute. Third topic Dr Peters you were asked some questions
14 about the Cox Richardson evaluation document which was dated 9 June
15 1997 and if I could just ask you to turn it up it's volume 9 of Ms Glackin’s
16 exhibits, exhibit 47 in volume 9 and if I could ask you to turn to page 98 in
17 the last paragraph.
18 A: Yes.
19 Q: Because of the time I’ll just try and short circuit this a little bit but if
20 you read that last paragraph it seems to indicate I suggest that the study
21 being proposed at that stage involved I think a number of steps first the
22 Ethics Committee, second call on the Cancer Register for the names of the
23 women, thirdly a trip to GPs to advise about the study, then the next step
24 would be to the woman concerned for information and for consent and then
25 the final fifth step would be to the screening programme Register so I’ll just
26 give you a minute to just see if that process seems to be the study plan that's
1 indicated there and I’ll ask you something about that. Glackin volume 9
2 exhibit 47 page 98.
3 A: Yes I’ve read it.
4 Q: It's just that if that was the proposal at that stage and the consent of
5 the women was to be attained, would there have been any legal issue about
6 Section 74A anyway?
7 A: No I don’t think there would have been.
8 Q: And therefore when later you identified a legal issue why was that,
9 had the Cox Richardson study proposal changed so that the woman’s
10 consent was not required. Can you just clarify that.
11 A: The proposal I’m most familiar with is the proposal to follow up the
12 cases of women with abnormal smears and that proposal the way it was
13 presented to me by the evaluators was that we would release the identifiable
14 information to the evaluators, I’ll call them evaluators as opposed to
15 researchers at the moment and they would then use that so it didn’t involve
16 the Cancer Register, it only involved the Cervical Screening Register and the
17 evaluators proposed to contact – take the identifiable information and
18 contact clinicians first before they contacted women and there was a legal
19 obstacle to providing that information without women’s consent. Now I
20 actually haven't studies the cancer audit proposal. I mean, I can't remember
21 what the order is that Dr Cox – I mean, it was clear that initial study design
22 was not going to be all right for that second component – not going to be
23 legally okay. I can't recall whether there was a difference between this and
24 the cancer audit proposal that I was eventually presented with, but if it did
25 involve us – I don’t even think I've seen the proposal because I think it
26 might have been held up at the Cancer Register.
27 MR MURRAY: That particular study.
1 A: Yes.
2 Q: Let’s get clear, the date on which you identified the legal issue, if you
3 can, on the basis of what was put up by Doctors Cox and Richardson.
4 A: It would have been in about November 1999.
6 CHAIR: Mr Murray there is an issue here and that is because this draft plan
7 of June 1997 wasn’t accepted and there was a revised version.
8 MR MURRAY: Yes.
9 CHAIR: when I look at this plan I see that they were going to get the
10 names of people by going to the Cancer Register because they thought that,
11 they talk about “the audit would consist of the Cancer Registry releasing to a
12 bone fide research investigator the name, address, date of birth, the name of
13 clinician for each woman registered with invasive cancer.” That’s down the
14 bottom of 1998.
15 MR MURRAY: Yes.
16 CHAIR: And of course Dr Cox has said the Cancer Register can't do that
17 because they require him to go to an Ethics Committee and he can't get
18 Ethics Committee approval, so that one failed. What his revised version
19 was in September/October 1998 which resulted ultimately in the Ministry
20 signing the contract in May 1999, we don’t actually have the evidence of
21 that revised version. If we had the revised version we would be able to look
22 to see whether he still intended carrying out the plan set out at p98 or
23 whether he had a different plan in mind.
24 MR MURRAY: Exactly, and the only point, which you are onto of course,
25 is which date do we fix the Ministry with an indication that they should have
26 been thinking about the legal issues. And it looks as though 9 June 1997,
27 on the basis of this study, is a bit too early because the trigger is not there.
1 But as you pointed out, it’s the revised study that we need, and then the date
2 of that revised study, and it’s from that point that one measures any delay in
3 identifying the legal problem of s74A:
4 CHAIR: yes, because Dr Cox at p2487 of the evidence, when he was
5 asked: “You submitted an expression of interest.” This is after the first
6 one had been knocked back. He says “yes”, and the question was – this is
7 Mrs Sholten’s xxn: “And that was in about September/October 1998”.
8 Answer “yes”. “The tender documents were issued at the end of 1998”, so
9 it’s obviously either the expression of interest he filed in September/October
10 1998 or something he filed when the tenders went out. And that tender was
11 received in February 1999. So you could perhaps track that information
13 MR MURRAY: We will track it and if Ms Glackin is coming back, as she
14 is, she might be able to clarify that date and address the issues around
15 whether the study that was received – or the proposal received then – raised
16 a legal issue or not. If it was the same terms as this it wouldn't, as I
17 understand this, but if it was different it may well have, and in any event it
18 did seem to result in Dr Cox taking up and making application to the Health
19 Funding Authority which Dr Peters is referring to. But we will see if we
20 can clarify that with some more evidence.
21 WITNESS: I think one of the problems is that the way things are written in
22 a plan may be different to how the application comes in in the end.
23 Sometimes they do vary in the process that’s going to be used.
24 CHAIR: Right. So certainly your understanding, if I take it in November
25 1999, you became concerned that you needed legal advice to see whether or
26 not Dr Cox could get access to the Screening Register?
1 A: I don’t think I've ever seen the request for Dr Cox for the cancer audit.
2 I think I've only seen the request for the non-identifiable data and for the
3 evaluation of the screening histories, or the follow-up of women with
4 abnormal smears, and it was that second one which triggered my
6 MR MURRAY: We will leave it there and get some more evidence. And
7 that’s all I have in re-examination.
8 CHAIR: Thank you very much. Well I'm sorry we've gone longer than we
9 have, but I thought it important to complete Dr Peters’ evidence. I'm sorry,
10 Ms Matcham that you are sitting down here. Would you like to start at 9.00
11 tomorrow morning to help us move through Ms Matcham’s evidence? First
12 of all we've got the finishing off the legal argument. We will do that first,
13 then we will move on to Ms Matcham and then Ms Handiside. I think it is
14 then Mr Lambie as well. We will see how we go. And we have Mr
15 Grieve’s application.
16 MR GRIEVE: Do you want to deal with that now Madam Chair? I think
17 we can take a rest.
18 CHAIR: You can think about it overnight.
23 THE HEARING ADJOURNED AT 6.17PM
24 TO RESUME AT 9.00 AM
25 THURSDAY 3 AUGUST 2000