Cervical Cancer Inquiry Hearing Thurs 27 April

THURSDAY 27 APRIL 2000
THE HEARING RESUMED AT 9.30 A.M.

DR BOYD (On former oath)

XXD MS JANES (continues)
Dr Boyd, just following on from where we finished last night, I was puzzling overnight, we have in the media at present the virus that’s infected the beehives and we have the Ministry of agriculture and forestry who have either themselves or contracted to carry out a random audit of selected beehives in order to ascertain the extent of the problem. Now, given that there were several indictors of concern in relation to Dr Bottrill’s laboratory starting firstly in 1989 with the general practitioner indicating concern about lack abnormals reported over a period of 3 ½ years, the visit two months later by the visiting medical practitioner and the comments in relation to firstly Dr Bottrill not wishing to increase his workload and the now well known “laid back to the point of falling over”, and if I can take you to your exhibit 26, this is in 1990, and obviously was the result of a survey of private diagnostic medical laboratories and if I can turn you to the third page in, that is Dr Bottrill’s response to the questionnaire, and you’ll see on the bottom % of smears being reported as abnormal and the response has just been question marks. Did the Department of Health at that stage particularly given the year earlier issues raised about the lack of abnormals, was any action taken as a result of what could only be seen to be an inadequate response or in the kindest light a clear misunderstanding or inability to answer the question – was that followed up by the department.
MR HODSON: that question would need to be put to the response from at least one other laboratory, which is 2 pages down, which is if Dr Bottrill is inadequate this is a complete failure
CHAIR: I see no reason why Dr Bottrill can't be used as one example
MR HODSON: I don't have a right to come back, but where the question is coming from, counsel for the commission, it should be complete.
CHAIR: if you are going to go beyond Dr Bottrill, it may pay to break the question up.
MS JANES: given the concerns raised in 89 with regard to abnormals and the visiting practitioners report and a year later this response to the survey which indicates either a lack of understanding about what is required or an inadequate response, did the department of health take any issue or make any connection in relation to Gisborne laboratories at this stage ..... to answer this first I would like to go back to many brief of evidence where we described this particular survey, which of course was being carried out to fond out what information was available to the department at that time to be able to build on, and I believe that that was related in my previous evidence. As far as selecting out any one laboratory for follow-up as a result of this, the answer is no, and the reason is that there is insufficient data and what the Ministry or department learnt was that with handwritten records it was very difficult for laboratories to provide back data over the years and that was the main result of this survey was that you couldn't carry out surveys of this type, using this particular methodology. So it was not a statistically relevant survey, it had no validity and the answer to your question is clearly no, no one laboratory was selected out for further investigation as a result of this inadq data.
Given therefore that as my learned friend has pointed out there were obviously misunderstanding or an inability to fill out these forms, what steps were taken by the Department of Health to make sure that meaningful and valid data was available so that these necessary comparisons could be made ..... quite obviously the main one was to introduced a cervical screening register where this data was collated, regionally, and could be interpreted nation wide and not to use the data that had been held in the laboratories themselves.
But Dr Boyd we've heard over many days of many expert groups and advisory
Committees that said the register does not work until you can correlate the histology and cytology. Was it reasonable for the department to be placing reliance on the register at that stage, knowing that the correlation did not occur until 1997 ..... I don't believe that a register does not work without the linking to cytology, obviously that was the aim and objective to link the two, even though they weren’t to be on exactly the same data base. And I believe it could be shown that collection of data through the register can have great value and it’s ridiculous to suggest otherwise
CHAIR: I noted you said cytology, did you mean histology ..... yes, that would be – cytology and histology to be linked, thank you ma'am.
MS JANES: we know the histology data was being received in hard copy from Ms Glackin’s evidence but her evidence also was that there was no ongoing annual correlation being taken with result to the cytology register. How then were those quality measurements and correlation being undertaken ..... firstly, there was the expectations that laboratories would form a relationship with their local colposcopists and obstetrics and gynaecology surgeons and I think as has been explained considerable times over, work was being done to get the histology and the cervical cytology data linked, it took longer than expected. This questioning started with could you use the data that was held in the laboratory itself and depend on that, and the answer came back this was, to my mind, no.
So we've got this survey in 90, which was intended to provide some measurement against which laboratories could gauge their performance, but clearly that the information that came back was inadequate, ..... that is correct it was to give baseline data on cervical smears because there were no national records kept up to that point and it proved conclusively that you couldn't use the data that could be provided by the laboratories from their day to day work, particularly historically .
And then we had the Norton review in 1993, which is at Ms Glackin’s exhibit 25, volume 5, would it be correct to say this review was carried as a result of the Department of Health indicating in 1992 that they would be providing the Programme Managers with averages so that they could monitor their results in the laboratories in their areas ..... I can't make that link specifically, you may have found it somewhere in the information. I can't at the moment make that link.
But going to the Norton review, on p2, it’s an executive summary of the results, are you aware what the Department of Health did as a result of the Norton review of laboratories or was it again just information that came into the Department of Health and disappeared into the labyrinth ..... my exhibits which include the minutes of the cytology liaison advisory committee are quite clear about the discussions that the national co-ordinator and the programme held with the Advisory Committee about this report. I wouldn't describe that as disappearing into a labyrinth.
On p2 it addresses issues of internal/external quality control, and it indicates 13 of the 18 community local laboratories, in particular in the Royal College Quality Assurance programme and 4 of the 12 hospitals. Did the department take any steps, either to encourage or influence the other laboratories to similarly participate in those programmes ..... my answers are going to sound somewhat repetitious but this was written before June 1993, and it was the expectation that the TELARC accreditation would be required by which time all laboratories doing cervical screening for the programme would be accredited and that would be an expectation that they would undertake the external quality assurance agreed. The standard at that time said there was no perfect external quality assurance programme but firm expectation that and encouragement to participate, so at this stage again the dependence was on laboratories preparing themselves for accreditation during the year 1993.
CHAIR: and was the Ministry aware that nothing was happening in that regard ..... it’s hardly nothing, 13 out of 18, I guess was the report they got tat this stage were already participating – it obviously wasn’t complete
If the Ministry was relying on the TELARC accreditation as the quality control measure and if it’s expectation that all laboratories would become TELARC accredited was not being met in 93 in the sense not all laboratories were TELARC accredited then, why didn't the Ministry direct that only TELARC accredited laboratories be used to read cervical smears for the screening programme. ..... ma'am, they didn't require that up until July the 1st, that would have been difficult if you accept one legal opinion. After June 30th, from July 1 93 on, the funding became a Regional Health Authority responsibility and of course was being covered in the funding agreements although we've learnt the funding agreements didn't carry on in the same way. This was definitely a time of hiatus but it was a time of changeover and one mechanism was not going to work after June 93 anyway.
But the Department of Health and then the Ministry would have been aware that it was going through structural changes and therefore mechanisms would have worked on wouldn't work under new changes. Why wasn’t something put in place so that the accreditation happened more quickly than it did ..... my answer, in hindsight, your question should be posed the other way, mechanisms that didn't work were being replaced – there was a very strong expectation from government that mechanisms provide a funder split would work much better because contracts would set out the requirements and you didn't need change the law to change things. So I guess that was the attitude at the time, that mechanisms such as the Social Security Act which had not given you a way to buy quality were being replaced by something that did. We've seen that it took time for this to bed down longer down than everybody would have liked now, but that was not the attitude of the government towards the changes in 93.
The contractual system being operated would have involved the contracts going through negotiations ..... yes, which was much better than before, there was no opportunity to negotiate.
As the Department of Health for example if you take the amendment to the health act in 93 which provided power for an opt off register that was a piece of legislation that the department was able to promote and once passed it effectively allowed for an opt off register didn't it ..... yes
And equally the department could have promoted legislation once a decision was made to run a cervical screening programme which would allow for aspects of the programme such as quality control and any other matters it was concerned to see implemented quickly have a vehicle for doing so via legislation ..... again, I think we've heard the evidence, the opt off legislation took some years to come through it is not as easy as some people might infer from your question, and any legislation is possible, I can find no evidence that was sought at the time and again I would have to say great expectation was put on the replacement of old fashioned Social Security legislation with something newer which allowed the person buying the service or the representative of the Regional Health Authority buying the service to closely relate with say the laboratory or any other provider that they were actually contracting with.
Given that there was this great expectation that the new system would work better, who in the Ministry was standing back monitoring the new system to see that the great expectations would be met ..... that is a very difficult one to answer, a system was set up to monitor the performance of the Regional Health Authorities, we will hear more about it, and obviously the different services represented amongst the different branches of the Ministry would be looking to see what was happening to the svce4 they were involved with. Obviously it wasn’t going to just suddenly appear before them within months as something where they could see the dramatic changes. So it was done on a full expectation that there would be improvements in the way controls could be put on what was purchased
And that quality was to be of a high order not matter what the health service being purchased was
Is there a danger when there is a number of players in a system more fragmented than a centralised system that gaps will appear and therefore there will be greater delay before there is a response to expectations that are not being met ..... yes. I'm not sure I should give opinions about the health reforms, there have been a lot we have all lived through, so fragmentation was actually one of the objectives was to break up a monophony purchaser and introduce the element of competition into health care services, but that was government’s intention, and that was felt that you would get better volume of service and better quality of service by bringing that keenness into the exercise
When it came to the laboratories reading the smears there was no element of competent brought in, there was no requirement to tender for contracts to read smears for the screening programme was there ..... as it was, I think you will hear from the Regional Health Authorities they rolled over the provisions under the Social Security Act and their strongest indicators of cstg for the first year were to reduce the colposcopy waiting lists and increase the enrolment. Selected indicators which were prioritised and the two important ones they were to report against were those two.
MS JANES: if one had grade one legislation because it was considered important what time frame would it take for that to pass through ..... legislation is so variable it has there are so many factors involved, if its budget night it goes through in 6 hours, if its anyone I'm interested in it takes 6 years or more or never gets done. That’s the variation. That's a fatuous answer to really say it is extremely variable, it depends on the priority that government of the day can give it and wish to give it and also what support there would be in parliament without going through a select committee process without calling for public consultation.
What power did the Ministry have to influence the priorities of government with respect of health and the National Cervical Screening Programme ..... again that would vary at different times with the seniority of the Minister who has a special interest with the amount of interest and with the rest of the legislative programme, and in this case health would have been taking a major part of the legislative programme with introducing the health reforms overall it would be only conjecture as to where a specific piece about laboratory service would fit amongst all that major health reform legislation.
If there was general consensus on a particular issue would that make it easier for the government of the day to feel that that could e passed in more haste than the 6 years ..... consensus amongst whom
For instance on the issue of accreditation, on the one hand you've got the Ministry and the Minister committed to accreditation in the 91 policy to be effected by 93, and you have the laboratories who have been advised of that policy agreeing to the policy because they believe they have been given sufficient time to implement and therefore it is a fair pool. ..... you may well have to ask the representatives of the private laboratories if that was the case at the time.
There is a document which was notes of a meeting of the private and community laboratories indicating that they were so. I will try and find that document ..... I'm not sure what the date was for that meeting, and I'm not saying you're wrong, I don't know I can confirm that in 1993, all the laboratories would say they were at a consensus point. It’s a lottery which I'm not prepared to bet on now
My concern is if we take the proposition that the government of the day is committed to accreditation by 93 and you have no conflict with the people that is going to be imposed on and overlaid with that is the concern with the restructuring taking place in 93 did it not have been a reasonable step is that correct particularly given that the other quality assurance measures were going to take loner to implement that the government passed legislation making accreditation compulsory for laboratories that were to participate in the National Cervical Screening Programme ..... I think it would take a better brain than mine to put all those factors into a computer and bring out an answer because I don't think my brain could, it obviously wasn’t attempted at the time, there were lots of things going on that you've listed, and I don't know what weightings to give to all those factors.
The question is why was the one simple thing that was readily achievable had no conflict by either party involved not bedded in before the Ministry felt that they lost control as a result of the contracting to the Regional Health Authorities in 93 ..... are you defining legislation as a simple Act just done like that
Can I put it to you it would have certainly taken less time than the 6 years that it has taken for accreditation to be compulsory for a regulation to have been passed ..... well it wasn’t, and I don't see any documents that suggest that any work was developed and it was taken through the system.
CHAIR: is it correct to say that, given the philosophy of the day, in terms of relying on commercial arrangements between a defragmented health system, that the notion of the Ministry using legislation either primary legislation or subordinate legislation was completely foreign to that philosophy and wouldn't have been contemplated for that reason ..... again I'm not able to say that that was the case. I can imagine that you would have an extremely difficult job to put in legislation about one piece of the health sector requiring central controls of it when the philosophy of the day being led outside the Minister of Health or Department of Health by a health reform directorate responsible straight to government was that the health department was not the appropriate place to be having those controls. I wouldn't have liked the job of pushing it through, I see no evidence that anybody contemplated that or worked towards it.
MS JANES: is it not the case that the department was actually resistant to the idea of regulating laboratories at this time, and I refer you to Ms Glackin’s volume 14, and the meeting minutes of the Programme Managers on the 23 July 1992, about half way through the volume, the minutes immediately prior are 4 December 1991. ..... I've got two versions, done in different type face, but if it starts laboratories and says that Cytology Advisory Liaison Committee had requested regulating of laboratories, that’s what it says, and that’s what it said the year before, when of course already the TELARC requirement was there and was in the policy and was known by all the laboratories. And by then it was expected during the new year TELARC accreditation would become a fact for all laboratories working with the programme.
Given this expectation and the reliance placed on that expectation, what was the department doing to ensure the department was meeting that expectation and adhering to the policy ..... I believe that would be one of the reasons for the Norton Report, to see just what activities were taking place in laboratories to meet 4.1.4, is it, of the policy? Certainly, the department did not go around to visit laboratories and audit them, so they sought out information in the form of the laboratory report from Valerie Norton.
But not all the laboratories actually responded to the Norton review did they ..... no, I believe that’s in the text, it doesn't – I'm not sure – no they didn't all, and it was a questionnaire, 18 out of 19 community laboratories and I believe as we've already said in evidence, we have searched, we have talked to the author, the author’s manager at the time in the Christchurch unit and the raw data is not available in archives and that’s New Zealand archives, its not available in the Ministry’s archives and it’s not held by the author and the unit of course has closed down.
Is it not correct that the ministry place such reliance on accreditation and their 99 policy for the reason that accreditation ensured that at least once a year in a cursory manner and every 4 years a full audit was carried out, that would actually ensure that there were internal quality control processes within the laboratories and also that there were satisfactory participation in external quality programmes as well as the normal certification management procedures in place. Would that be fair as to such importance was place on accreditation ..... I haven't seen it written down just like that – that sums it up, yes, it was an example of the optimum regultry model where the regulator, government, sets standards, agreed with the industry being regulated, and the industry itself contracts the auditors to provide the assurance that they are in fact meeting those standards and have the systems in place to continue to meet the standards. So it’s descried as the optimum regulatory model which were introducing into food, hospital licensing, and it was obviously being used here in laboratory services.
So is it also fair to say that as long as laboratories were accredited the Ministry would have a degree of confidence ..... a degree of confidence only because I've already agreed with Professor Duggan some days ago that just having accreditation from a third party auditor cannot guarantee safety or quality of service but it is a degree and a significant degree of assurance.
Given that you seem to believe that the department did not have the ability to legislate, which I would question because we have seen superannuating go overnight, so where there is a will there clearly is a way, putting that to one side if there wasn’t the necessary commit to passing legislation for accreditation was there not the alternative that in providing contracts for the service of the programme that the department could specify that only accredited laboratories should qualify for reimbursmt under the programme and I take you to Glackin 11, ..... first of all before you do, laboratories were never reimbursed under the programme with the Social Security Act, they were reimbursed for providing cervical cytology as part of their laboratory's services,
But we have seen under the Social Security Act there was the ability to make it a condition ..... we have discussed that with a previous counsel, that there was ability for the Minister to make conditions, that would obviously have to be consulted upon, we agreed that I could have drafted a discussion paper and a paper for the Minister supporting that, knowing that was an ability under the legislation, the answer has to be no, it was not done, dependence was placed on the forthcoming TELARC registration.
But we've seen that registration was not forthcoming, would it not have been an alternative that contracts would only be honoured or contracts were put in place that only TELARC or some other accredited laboratories should e entitled to participate ..... you're talking after July 193 when contracts were to be managed y the Regional Health Authorities
We've seen between the period 91 to 93 which is the period first set for accreditation to take place that didn't happen for whatever reason, and no legislation was put in place, and no regulation was put in place despite the fact that there was no resistance from either the laboratories or the Ministry, so if that was not a viable alternative would it not have been cost effective and efficient in the funding agreements that took place in 93 for it to be a condition that only accredited laboratories be utilised for the cervical screening programme ..... I'm going to say I don't know because I wasn’t party to the funding agreements with the Regional Health Authorities nor was I party to how best endeavours got placed in there in many places and I'm not privy to how the Minister at the time wished to set out those funding agreements.
If I can take you to Ms Glackin’s exhibit 11, volume 3, and the minutes of Cervical Screening Advisory Committee held on 12 December 91, p2, the third paragraph after “Matters Arising”, you've been and about the Rotorua concern so we won't traverse that again, but if I can take you to the second paragraph after the Society of pathologists have recommended that the Rotorua registry become TELARC registered, it says: “If the laboratory does not … after 1993” ..... correct, that’s what it says. It doesn't say who would enforce that or how it would be enforced – I don't know who wrote this or who is being quoted or if it – it is difficult to see how this would be applied without all the qualifiers.
We have a range of very sound expert recommendations contained in minutes and reports ..... where is this a recommendation, it’s a statement of a discussion and I'm not sure who said it or how it’s reported, nor does it say how it would be applied.
Clearly it was considered to be an option that if a laboratory was not accredited after 93 that no further smears should be sent to that laboratory. Could that not have been adopted across the board by the Ministry – this as an expert committee after all ..... but it’s not a recommendation of an expert committee, you answered your own question previously I believe by saying you would have to go through the process of getting the Minister to put on a condition of funding under the Social Security Act. I don't see any reference to any of that here, and in some ways this is like the reporting of this inquiry with the headlines being based on a statement in a question from counsel not an answer or the documents.
Putting the media to one side, how did the Health Funding Authority or the Regional Health Authority in 96 manage to put in place compulsory accreditation when the Ministry was clearly not able to do so ..... I believe you will have to ask them, I presume this was contracting, working in the way that the 93 officials would have expected it to work.
Why was that expectation not in place for the 1993 contract round ..... it wasn’t and I can't give you that answer
MR MURRAY: there is a point that arose yesterday, but I think I should interrupt, the question is being questioned about factual matters and he is not a lawyer. It is fair to this witness that this issue be identified.
CHAIR: I have difficulty in understanding this point. What is of interest to the Committee of Inquiry is whether the obligation was being discharged and in what manner it was being discharged.
MR MURRAY: there is an Act that has to be factored into this line of questioning.
CHAIR: what is bothering the committee is under the funding agreements it does say the responsibility for the laboratories will remain with the Ministry of Health and that is why the Ministry of Health is still being and about this.
MS JANES: understanding you are not a lawyer, your knowledge and understanding of the functioning of the Ministry, was there any way that accreditation which was both cost efficient and effective given that other measures would take longer, was there an availability to bed down that one quality assurance area before control went to the Regional Health Authorities ..... you haven't asked me that before and the answer is I am sure there was a possibility, and you did quote me previously as saying we have no ability, that isn’t so. There was a possibility, it was not used, and my feeling is that it would have been extremely difficult but no one tested it.
Given that there appear to have been a significant number of concerns referred to the Advisory Committees over a period of time, and in your evidence at p38 it goes through the procedure for steps to be taken if there appears to be inadequate performance. Was there a repository within the Ministry of Health where all these strands, whether they be from the local Programme Managers, the national co-ordinator, the public as we've seen there was the letter from Dr Hitchcock, there seem to be a plethora of places where concerns channelled through the cervical screening programme, where would they have ended up in such a way that they could have been correlated and some action taken ..... I think p38 sets out the expectation at that time, the national co-ordinator and Cytology Advisory Liaison Committee as it Was then agreed that if the cervical screening register identified a problem and I would take that to be if there were identified problems with laboratories from any other place than the register, that first it would be with the national co-ordinator who it was agreed would be discussing with the Chair of Cytology Advisory Liaison Committee on a monthly basis at least issues arising. They would decide whether to take it to the committee for advice or I'm sure in some cases the national co-ordinator would work on the advice of the chair of the committee alone. So, yes, letters get addressed to different people within the Ministry about the programme, my perception is that they would have ended up in the hands of the national co-ordinator who then, if it was a laboratory issue, discuss it with the chair of the Advisory Committee and the full committee if appropriate and the action would be referred back to the Ministry or the national co-ordinator for the Ministry because the Advisory Committee would have had no disciplinary powers or no rule making powers.
CHAIR: you mentioned p38 of what ..... I was referred to p38 in my brief at the beginning of the question.
MS JANES: you are correct that the Advisory Committee’ had no disciplinary function, neither did the national co-ordinator role have any disciplinary function. Are you aware that the procedure for referral through to the Ministry who was the only body certainly in 1991 to 1993 that had any ability to direct or enforce or take action, was that procedure working in practice ..... there are examples where the examples I've given, the information certainly got to the national co-ordinator who certainly sought advice from an expert in the field. So, there is evidence there that it was operating. I wait for you to find me one case where it didn't.
CHAIR: who between 90 and 93 had any disciplinary function in respect of the programme ..... that’s over – it depends which service we’re talking about and which sort of provider, if you start with non-medical smeartakers they don't have a disciplinary process but I would imagine there could be some pressure put to no longer contract with them or to no longer use their services. Medical discipline, there is a disciplinary process and as counsel have pointed out there was the ability for ministers to put conditions on but it was never used over laboratories using cervical screening at that time, but I said in my evidence on the first day, the threat of non payment was always something it was believed kept service providers in line, so that would have to be referred to the Ministry itself over that period of time – it would be referred to another branch of the Ministry. That would apply to laboratories and doctors providing services under the programme and obviously there would also have to be thought about what are the controls over staff idn the abnormalities running the cervical programme and presumably if there was national concern over a particular Programme Manager or their competence you would go to their employing Area Health Board.
So the national co-ordinator had no disciplinary function, did she ..... no, I believe she employed a small number of staff of her own, over whom there would be employee/employer controls – she didn’t have power to discipline.
In terms of the cervical screening programme as a whole there was no one person who had disciplinary control over all aspects of the programme was there ..... no.
And is it correct to say there was no one entity that had disciplinary control over all aspects of the programme ..... no, and that’s partly a factor of there being no new service developed, this was built onto existing services.
I think your answer is yes rather than no.
MS JANES: but the national co-ordinator was charged with identifying issues and potential problems and dealing with them proactively, Ms Glackin’s tab 2, p3. but given that she had no disciplinary function and the committees had no disciplinary function it was reliant on some communication taking place between either of those two entities or individuals to the Ministry wasn’t it for something to actually occur ..... if were talking the national co-ordinator of course she, and it was always a she, was an officer of the Ministry so it was a matter of talking to the appropriate branch or section of the Ministry if there was action to be taken about a funding issue an issue of refusing payment or putting controls on a laboratories services bought from them, and I see no evidence that it got to that
Who in the Ministry would she have referred those recommendations for non payment or other sanctions to be imposed ..... first it would have been the medicines and benefits section which was part of the break up of my clinical services division, then that became just the benefits section and medicines went off on their own. There was a manager of a section which managed health benefits over all that period of time.
Dr Boyd, the panel asked yesterday about the incidence of cancer in the Tairawhiti/Gisborne region at the period under review of the inquiry. If I can just show you this media release. The first paragraph indicates that the incidence of cervical cancer in Gisborne was up to 40% higher than it was nationally during the period being examined by an inquiry into the pathologist Dr Bottrill. The second paragraph indicates that in the same period, both Northland and Bay of Plenty had a higher incidence of cervical cancer also. ..... no, than Gisborne.
And that raised the possibility that the differences are due to the ethnicity of the local populations and not the possible reading of thousands of cervical smears. It further goes on in the bottom part, that Dr Feek said that all three areas figures were affected by the fact the cervical cancer rate amongst Maori women was about double the rate in the general population. I just want to refer you back to the laboratory comparisons that were done in 1996, which is tab 29, but I actually want to produce the full report that was done by the Ministry.
CHAIR: what is the basis upon which the newspaper article is being produced at the moment.
MS JANES: the relevance being with the laboratory comparisons the panel asked questions about the rate of incidence and how comparable the statistics were given there may be different socio economic, demographic and disease indicators that had not been extrapolated and therefore the data was not comparing like with like – to give an indication there are areas where the prevalence of disease is higher than the national average.
CHAIR: we need to be sure that the statistics reported in the article are correct. ..... I can't look at them and say whether they are correct, I can report that after our briefs of evidence were written, I believe, we in the Ministry pulled out from our national health information service data for Nick Mailing to use, and we provided him with the figures – whether they have to be transposed correctly, it would take time to work out.
MS JANES: perhaps the press release from the Ministry could be provided.
CHAIR: the registry data is the best data. You could ask Dr Boyd to comment on the statistics, and if you are happy the press release could go in later ..... I think it was based on a press release – it must be in written form somewhere.
MS JANES: do you believe it would be your impression that the statistics for Northland, Gisborne, Bay of Plenty figures provided in that article would be based on those collated by the Ministry ..... that would be m y expectation, and there are always a lot of qualifiers that go out with incidence and death rates of one disease in a small population such as Gisborne, Bay of Plenty and Northland.
I understand that statistics may not particularly be your background, but is it not correct that in order for statistics to be meaningful a similar set of assumptions would have to be applied and if there are divergences between different regions they would need be taken into account in order to make comparisons meaningful ..... they have to be taken into account by somebody reading the numbers, they may not actually have been taken account of in creating the numbers because the numbers are just cases/hundred thousand, so some of those qualifiers have to be on how you read the data, just as we were hearing about the laboratory reports yesterday.
I reclctd one of your answers to the panel questions on these laboratory comparisons yesterday was that they compared like with like. Is it your understanding, based on that answer, that somebody within the Ministry actually collated the data with similar regions and made the necessary adjusts to be able to obtain an average, under tab 29, the larger series, the 96 full laboratory report. ..... I think I’d want to know what it is you are asking, these are numbers of reports put out by the laboratory and those there had to be work done on those because there were duplicates in the register and there was tidying up to be done of that data, however, they don't relate to rates of disease/hundreds thousand of any ethnic group or population nor do they draw a boundary around a region in which the laboratory received the smears, so all those things have to be taken into account when you compare these results with those results.
I'm not a statistician either but in trying to think through the issues we understand that Gisborne has a higher rate of incidence, there is a significantly higher proportion in the region that are of Maori ethnicity and we understand that they have up to a double rate of incidence of cervical cancer, and we heard from Ms Glackin that in the early stages in Tairawhiti it was the high risk groups that were targeted on the opt on system. it seems to me that with the combination of those factors, that there should be abnormality readings in the higher of the national. Range, not at the lower of the range, which is where Dr Bottrill’s laboratory was reporting. Are you able to comment on my statistical analysis, whether that is reasonable ..... I heard you make one assumption which might alter the whole thing, you made the assumption that targeting for the opt on and I don't understand what that meant, certainly people were targeted with advice about getting smears and were sought to come to have smears from the high risk groups at the beginning of the cervical screening programme . that doesn't tell me that they necessarily opted on and got their names on the register in those first years, you've made an assumption, I don't know how you could verify it.
But given that that was the evidence we heard, that they were the individuals who were first targeted or invited to participate in the programme ..... no, they were invited to have a cervical smear and they were told about the programme and the publicity was part of the programme, but there's nothing to say that they then made a decision to opt on or not opt on – you've made that assumption.
Given that we have a region with the higher incidence and high Maori population which has dlbed the incidence would it not be an expectation that the reporting of abnormalities would be in the higher range rather than the lower range ..... that is certainly a reasonable assumption to make and it was obvious to me that was the line of questioning before, but I am not able to confirm who it was, which parts of the population were the Maori chose to opt on or not, so you are making an assumption, you are apparently asking me to confirm something which seems reasonable, but that’s as much as I can confirm.
CHAIR: as a public health specialist having that information before you would you make that assumptions yourself ..... it seems reasonable but there may be other factors who attended, who opted on, but if there was a higher incidence of disease amongst the people having smears then certainly you would expect more positives and its obviously fm the positives that you get the false positives
So you would make the assumption but qualify it with that additional knowledge that you didn't know at the time the nature of the people operating on the scheme e ..... it may not be a big factor at all, it only came to me when we thought about this overnight, but it’s not necessarily an explanation and there will be more the inquiries hears about false positives and also you have the opportunity to speak to epidemiologists, particularly Professor Skegg is interested in those people who develop cancer of the cervix and follow them through
You would make the assumption but it would be a qualified assumption ..... it would be qualified.

MID-MORNING ADJOURNMENT – 11A.M. TO 11.15A.M.

CHAIR: Dr Boyd, before the morning adjournment when you were being questioned about the incidence of disease in Gisborne at p637 of the notes of evidence you were asked about the assumption that you would make as public health specialist and I said to you “so you would make the assumption … the scheme” and your answer was “It may not be a big … overnight.” Could you tell me who the “we” was ..... did I say we, if I did, that must have the Royal “we” 0- no, I'm afraid I didn't discuss this issue with any – no the rate of cancer I didn't discuss with anyone, the laboratory results this morning I did discuss with the author because the inquiry was wanting to know her qualifications, so no I don't have any other expert or legal advice on that. it says operating, but I am sure we were opting on.
CHAIR: yes, you are quite correct.
MS JANES: just concluding the questions in relation to these comparisons, are you aware whether the person responsible for collating the results of this review actually took into account regions that had similar demographics, similar socio economic profiles ..... not in compiling those results. It was the matter more of getting the data correct about what the laboratory had actually reported and that there was only one report per case. So, no, it did not and quite clearly in the results do not reflect any demographics offer the region being covered by that particular laboratory
Would it be correct to say no real meaningful extrapolatns could be taken from the data ..... I don't believe that’s reasonable to say at all. I think I pointed out yesterday that the type of information continues, has continued to be provided to laboratories and they themselves have, as part of their analysis, looked at the populations they serve and have been able to explain to their satisfaction to people who might have questioned them, some of the variation for their own laboratory.
PROFESSOR DUGGAN: this document highlights variation in laboratory reporting between the community and hospital laboratories ..... yes
And there were questions from the Programme Managers with reference to these variations ..... yes.
As well, you weren’t able to tell me whether this variation was discussed by any of the Advisory Committees or the professional associates of the pathologists ..... I wasn’t able to point you to it I believe that in discussions I've had with Programme Managers and previous co-ordinators in the recent past are that these results were taken to the - I think it was the cytology Society where all the pathologists meet who are involved in cytology – we don't have minutes of those meetings, but I think that they were discussed in that forum. But they were also provided to the laboratories for their own internal use.
Yesterday you said to me that these documents would be falsely reassuring to an individual laboratory, is that correct ..... I think I would have agreed on something like that, without the laboratory knowing or understanding its local population.
What assurance does the committee have that the laboratories do actually review these documents within the context of these limitations of the design ..... I can't give you that, I think I have said everything I know about how they’ve been used, so I can't give you the reassurance you're looking for and I hope somebody else would be able to who later appear before the inquiry.
I would like to repeat that they can be falsely reassuring, and in fact would you agree that they can be meaningless if they are not critiqued within the context of their design limitations ..... I defer to your judgement on that. I guess in bringing them along I did not see the limitations as you have seen them, but I will defer to your knowledge on this, yes, if yes is the correct answer. So, yes, I agree that yours seems a very well founded argument.
CHAIR: the limitations were not expressed anywhere in any communications to the laboratories were they ..... I can't find any evidence of that, no.
MS JANES: you've indicated that laboratories have received other comparisons similar to the 96. how regularly were they receiving these comparisons ..... Certainly I've been told that the more recent ones are 6 monthly and I think I refer to this somewhere in my brief of evidence that they caught up with the time lag so that they were about 3 months behind when they got their 6 month report in the more recent times.
Would that be similar in form ..... I understand the format’s similar, they aren't of course on our files and that’s what I've been told
Who would have copies of the performance comparisons generated since this 96 document ..... I believe they were sent out electronically, they are part of the register, so that is where I’d expect them to be with the current cervical screening register but they may be in electronic form now and not hard copy to provide just like that.
Is it the expectation that these are sent to the laboratories and it’s very much at their discretion how they apply the comparisons as a quality control mechanism ..... I think how it’s used currently would be better with the people who are running the register at the moment, certainly they are sent to the local Programme Manager and obviously they would form the background of discussion at Programme Managers meetings, but there's little in my evidence to record that except the concerns that you've seen and that have been referred to.
We've heard a lot about the laboratory concerns that have been generated from various parties involved or interested in the programme. Is there any point where in the department there is a person or a section who would have access to those concerns as well as the statistical data that is generated so that there would be comparisons capable of being made that may alert the department to potential issues in laboratories servicing the programme ..... up until the time that the Register was with the department then the Ministry of Health it would certainly be the register, the national co-ordinator and up until 96 the cytology liaison advisory committee. After that time I would think it would still be the national co-ordinator and the manager of the Register as part of running the programme.
And would the national co-ordinator then have referred it to what department or section in the Ministry if there were concerns to be followed up ..... depends what the concerns are, but the most likely one would be that up until 93 it could have been one for funding, in which case it would go to the health benefits section, after 93 it would go to - probably the first call would be the relationship manager for the region in which that laboratory was sited.
So would all this information eventually be centralised somewhere ..... within the cervical screening programme and on its files and in its memory would be the central point. There isn’t another Ministry section which is collecting information on all points about cervical screening.
Was there not a problem therefore, I understand there were, the staff turnover was reasonably significant and resources were a problem. Is that perhaps an issue as to why there was not the institutional knowledge of concerns raised, ether about the Rotorua laboratory in 91 and 93, or Dr Bottrill’s laboratory in 89 and 90, to be able to make the necessary connections for the alarm bells to be ringing and for some action to be taken ..... I don't know I can answer that specifically yes or not, there were staff turnovers, there is a filing system, there is some continuity amongst the Programme Managers and the other people that the co-ordinator relates to, but it is always possible that staff turnovers can lose you institutional memory.
You indicated yesterday that quality mechanisms or quality assurance was a difficult term to define. But would it not be fair, given all the expert recommendations we were certainly able to extract several principles of quality assurance – for instance did the department agree that quality assurance would be provided through provision of previous smear histories for laboratories reading for the programme ..... having the previous results available was considered an issue for getting the best quality results from the reading of the present smear, and I understand the availability of them to the laboratory. If the woman has been on the programme, then that availability has been there all along.
But there was a problem with the 14 registers and a mobile population ..... that certainly was a limiting factor on somebody who had moved and whose own clinical notes hadn't moved with them to the new general practitioner or smear-taker who hadn't collected a full history before sending the smear off to the laboratory. So that if they didn't have the report it would be known where the report could be found.
And would you agree that another quality factor identified early by all experts and the committees was the urgent priority of correlating the histology and cytology which didn't happen until 1997 ..... throughout that’s since long before the programme was established that’s been seen as an important measure of the functioning of the smear-reader.
And another aspect that was also considered important by all of the Expert Group s and committees was the need for accreditation because it takes into external and internal quality control measures ..... again, that has been a long term issue, and so it has been repeated by several committees right from the very early meetings.
And the last plank of quality assurance that was universally agreed upon was evaluation and monitoring was it not ..... that’s more difficult to define, but yes, any programme that’s set up should have some indicators of its own performance and some targets which are within its own control to meet. And those are quality features.
Given the implementation of a programme such as a National Cervical Screening Programme, how reasonable does the Ministry believe it’s been, the time elapsed for each of those 4 quality control planks to come into effect ..... regarding the last one, there were targets set on outcomes from the programme and they’ve been more than achieved. So that doesn't mean the service was of high quality in all its features but targets were set for it and they were known about and aimed for and they were exceeded. Regards TELARC, I think we've heard considerable amount about the delays and the expectations and how at each time the officials involved and the people running the programme expected something to happen and worked on that expectation and took much longer than anybody would have envisaged for TELARC accreditation to occur.
If we take each of those 4 quality assurance elements as the 4 corners of the foundation of a house, and given the length of time that it’s taken to implement them and balance in implent in quality priorities, does it not leave a shaky foundation for the implementation of the programme until they came into place ..... if they were the only foundations that – your analogy would be perfect. Obviously there were some very good things and in some ways the cervical screening programme has exceeded perhaps what I envisaged in my expectations when I stopped having anything to do with its implementation, so there are some very good points, the enrolment numbers, the involvement of women in this country, the high regard that the programme has had, there are the reduction in incidence of the disease that the programme was set up to reduce. Those are some features of this house of yours as well that have to be taken into account.
Thank you.

QD BY MRS BARRETT:
I would like you to turn to your evidence, p22, about competent personnel, paragraph 66, and it talks about smear-takers. I want to address 66, 667 and mainly 67.1, and the paragraph afterwards about the non-medical smeartakers and the lay smear-takers and going into the medical practitioners. I just wanted to know from the non-medical smeartakers that are usually r/nurses, the NZQA accreditation in the course is that part of their training when they are training as a registered nurse ..... no, that’s some people have been unhappy that I've used the term non-medical smeartakers and not separated out nurses, but cervical smear taking is not part of the undergrad training of a registered nurse, so they are expected to take a course before being given a number to be able to send their smears to the laboratory for testing.
Has the panel got copies of the accredited course, are they part of the Ministry’s exhibits ..... no I don't believe the course material is
Is it massive ..... I guess because of that I can't tell you what size the course material is, but I wouldn't expect it to be very large because experience and training with a qualified smear-taker and on the job training is an important part of it.
It might be of interest madam chair that the panel could have a copy of that ..... I will ensure that you get the training material that a would be smear-taker would have to go through.
Going to the lay smear-takers and there is a vast difference between the non-medical and the lay smear-takers, are you able to tell us what is the additional training that lay smear-takers have to have, or do they have any at all ..... I think that is up to the group which employs them or contracts their group to decide what other training is required in a general health context. In some ways it is unfair to call those people as just lay because they may be health workers with many years experience in community health issues, but they may have no knowledge of the cervix and how to take a smear, that’s the bit we want to ensure they're trained on, the other training about the health sector and health of women is not part of this programme.
The last sentence of that paragraph says clinical support from a local general practitioner … is usually arranged by the local co-ordinator. Are you able to tell the panel whether that happened ..... I can't give you chapter and verse, I was told that’s what happens at the local end, but no I can't be an y more definite than say I have been told that and perhaps it would be something that the Programme Manager co-ordinator that we intend to call could elaborate on for you.
Going onto the medical practitioners are you aware what amongst the vast amount of paper that we have I had read somewhere where the medical practitioners were not happy about not having non-medical people and lay smear-takers. What is your view on that ..... there was definite resistance from individuals I don't believe the medical associate or the college of general practitioners ever came out with a policy statement, but I was involved with setting up the pilot studies through union health clinics and certain Maori health provider groups before there was a cervical screening programme and there was definite resistance to other people being involved in smear-taking and some of the argument of course had to be taken account of in the training programme because we have heard that taking a cervical smear in itself is not sufficient one should be able to describe the characteristics of the cervix and be able to recognise possibility of disease which should be referred on to a qualified medical adviser. So they brought up the individuals I talked to, the fact that other people did not have the same training as they as a general practitioner had had in identifying disease in that area.
It may be a question that I could ask the Medical Council ..... you could. Whether they would comment on the training of knowledge of other people, I don't know.
It’s just that the Medical Council is responsible for medical practitioners, they monitor the profession, etc ..... they will have an expectation as to what training in gynaecology somebody should have before being fully registered as a medical practitioner.
I want to compare the three smear-takers in terms of I think the expectation of women overall would be, that they would strive for excellence in service of care. I want to go through those with you. can we move on to paragraph 76 of your evidence. Under the Act, 1995, pathologists to hold a vocational registration are you aware whether – is it your understanding all pathologists in New Zealand have completed that training ..... this is under – this applies absolutely to anybody who wishes to get on to the register and become a pathologist after 96 when the Act came into force. Before that, the Medical Council has always had requirements that a pathologist must have had training to a degree that satisfies the Medical Council before they can put them on the register. If we take Dr Bottrill as an example, his training would have been quite some time ago but I believe the Medical Council at that time would have had to look at his qualifications and the time spent in training before they first put him on the Register but it was obviously under an earlier legislation than this, no-one could become a pathologist just by deciding to be one.
So we won't be having any of the slip ups that we have had in the past ..... I wish that was so. This is I guess under the heading of general quality assurance and entry into the profession is one quality assurance measure continuing competence is another one, and the new legislation has this provision which says that every specialist in a specialty must recertify themselves every 5 years by proving that they’ve undergone some postgraduate education and that they have achieved competence and maintained it through that time. That’s new, it’s coming into force, next year it will be fully in force the 5 years in which doctors have had to show their competence and gain the points required have been happening from 96 to the present day and through until next year. So that will be another step of improvement, but still no absolute guarantee because it requires oversight from other practitioners, behaviour and it does require the practitioner to recognise faults in themselves.
Would the Ministry of Health be putting any policy in place to make sure – you touched on paragraph 78 as well in your answer, but would the Ministry of Health be setting policy to make sure that that happens or the Health Funding Authority ..... well, the policy was set in drafting the legislation to make the Medical Council responsible for seeing that doctors maintained their competence and decide for – the Medical Council to decide how this should be achieved. No, the Ministry itself is not going to monitor individual doctors to see that the Medical Council’s work has been achieved.
Paragraph 105 of your evidence. The training of laboratory assistants. I was going to ask is there a shortage but you actually answered that a little further on in your evidence, but could you tell us who is fulfilling that role now if there aren't laboratory assistants in place in some laboratories at the moment ..... I wouldn't want the stopping of the Central Institute of Technology course to be represented as no training for laboratory assistants, there still is a qualification, but it’s a correspondence course and they sit an examination at the end of a period of time. That is still, there is training opportunity for laboratory assistants, so they are fulfilling that role in laboratories. We have heard indirectly that the Gisborne laboratory did not employ a person in that laboratory assistant role, and I don't know if there are other laboratories which were in that same position or whether that’s the case now. But if laboratory assistants weren’t the primary smear-readers then a laboratory technologist would have to be, and that is somebody with a university qualification in laboratory technology, or as we've heard, the pathologist, and there is also in the Acted an opportunity for medical practitioners who are not registered pathologists to also read smears without being under supervision.
I want to actually take you to paragraph 106 of your evidence, part way through your evidence it actually says – this is part of the Cytology Advisory Liaison Committee August 94 meeting – that “these competencies had been developed … laboratories” is there somewhere in your evidence that those competencies are provided ..... it appears not. It appears they weren’t – the draft was not made as an exhibit. It was a draft, it was discussed at the committee, the committee in the last committee meeting notes I have seen still was recommending some changes, but the final draft is now there as an exhibit and I would expect that we could continue to search to find it. So, I will undertake to have that provided if it can be found.
That was my next question, whether you could make that available to the committee ..... yes, I will make every endeavour to
Are you able to tell us who in the Ministry of Health actually did the competencies ..... I believe that it was probably noted in the minutes, the person attending the committee meeting, I got that impression, I’d have to refer to the meeting of Cytology Advisory Liaison Committee and Cervical Screening laboratory Advisory Committee meetings in my volume 4. in any volume 4, tab 18, the draft agenda of the Cytology Advisory Liaison Committee of Friday 19th August 1994. there's a draft agenda, and attached to that is a draft standards for cyto technicians, and attached to that is the list of people who were involved in being consulted in the preparation of the paper, and probably in the minutes there would the mention of the person who pulled it all together – Leslie Harwood is the name of the person who pulled it all together.
CHAIR: I have 15 June 1994 and then I go to 20 September 1994. what is immediately in front of your agenda of August 1994 ..... there's a service agreement for the Cervical Screening Advisory Committee July 1994. I go 29 June 1994, my volume 4, tab 18. Leslie Harwood was a Ministry employee, not in the cervical screening programme but probably in our management support area, pulled together the competencies and used the list of people at the back for advice on the competencies themselves.
MRS BARRETT: Leslie Harwood actually worked for the Ministry of Health ..... I believe so. She wasn’t a member of the committee and I believe she didn't work for the cervical screening programme itself, but I'm not certain about that. she was certainly a Ministry employee and it was a document prepared with consultation with a considerable number of people with knowledge in the area.
To follow on about the Central Institute of Technology course, I know somewhere in Ms Glackin’s evidence she stated that the Ministry of Health serviced etc., did a whole host of things, for the expert groups and the advisory committees that the Ministry of Health had, is that correct ..... yes, of the ones I know best about, the cytology advisory liaison committee actually was established outside of the Ministry and after its first 2 meetings then the Ministry provided secretarial services and travel expenses and other needs of the committee. The Cervical Screening Advisory Committee would have received that support all along, the members in many cases would have provided their services for little or no reward.
Can you then tell us in the servicing role that the Ministry of health was providing, in this case to Cytology Advisory Liaison Committee, who in the Ministry of Health would have negotiated the extra funding for the Central Institute of Technology course ..... it would have had – the funding was in the health development workforce fund which had its own management within the Ministry, that would have had to have been a decision taken at the very top level to put that much funding aside, so the decision would have been made I'm sure by the corporate management group. the decision was made right at the time this would be for 3 years and the funding would then come from like any other tertiary institution funding, I can't give you the name of who did the relationship with the Ministry of education to be able to draft the papers to the Minister to advise what was happening, but it clearly had to be written by somebody with authority in the Ministry having gone through the issues. It would become some part of the policy of the Ministry, it wasn’t the cervical screening programme co-ordinator herself I don't believe.
Its just that when we went to some of the evidence, and I think it was some of the exhibits that were provided, I'm not sure where, there was an actual strong recommendation from the then Associate Minister of Health of going to the Ministry education to negotiate I guess funding for the Central Institute of Technology course. I'm not sure about the logistics about govt and I don't want to know about it either, and government agencies, but if a Minister makes a strong stand like that I would assume that she was very clear that funding would be forthcoming for that course because she would have no doubt spoken to the then Minister education if they spoke to one another to actually negotiate that Central Institute of Technology course don't you think ..... if you could take that letter as being strong support, my reading of it is that the decision was made at the beginning of the course that after 3 years it would become part of the normal tertiary system when time got near the Advisory Committee recommended the course continue as is, the decision was that the policy would not be changed and the Ministry would not start funding the course beyond the 3 years, that had never been the policy, and the decision at that point, if that was government’s decision, the policy stood, then the Ministry of Education and I think the letter advised that writing support for the course to the Ministry of Education was the correct thing to do – it didn't say “I am going to fund it”; it said “I advise you to put your views to the Ministry of Education.”
Do you think that the Ministry of Health really stuck its neck out to make sure that funding was available from the Ministry education – did the Ministry do justice to it ..... that’s – I don't know the answer to that. we've heard a lot about government policy and how it should remain unless its changed positively, this clearly government policy set out at the beginning. The Ministry did not arrange with cabinet to overturn government policy in that issue, and that’s as much as I can find. It would have had to meant a change of policy for the Ministry to come in again as the funder for a course which was not proving to attract sufficient people to maintain itself
Are you able to tell us whether in fact the Ministry of Health had a good relationship with Central Institute of Technology and NZQA as well ..... certainly the person running the course at Central Institute of Technology had or was a member of the Cytology Advisory Liaison Committee I can see no evidence that there was any disagreements amongst them. Obviously he would be a very disappointed person when the decision was not made to overturn government policy. I don't know how relationships went well. I think I've seen his name amongst the committees advised will be making submissions, but I haven't spoken to him about this issue.
My last question, and you kind of went over it a little bit yesterday, is in your volume 5, tab 22, about off site home screening ..... yes.
Some of the – and its in reference to TELARC – comments being made in there were reality for me as a lay person. In terms of “the committee recognises that in … no home screening … in this role.” What is your view about that ..... it was inevitable that it was going to be phased out and yes I did have some involvement before this time in looking at home screening. Where I looked into it these were extremely experienced, competent women who had been in the workforce and then had home commitments and were doing some of their work at home, unsupervised, and hopefully in the quiet time at home when children were in bed asleep or they weren't distracted, and their work of course was checked to the same level as if they'd been in the laboratory itself. And most of them came in or all the people I talked to came into the laboratory one day a week, for liasing with other staff members. That’s how it had been for a considerable period of time. It was obviously unsatisfactory, there had been considerable writing about this in the American general media and it was going to be phased out. The staff themselves wanted to keep working that way rather than take full parental leave which wasn’t probably reimbursed at that time. So it would have meant losing skilled people from the workforce but it became inevitable that it would happen.
Thank you.

QD BY PROFESSOR DUGGAN:
Could we return to The flow diagram in volume 3, the last page. This was how the group at the National Cervical Screening Workshop envisioned the screening programme ..... it appears so, yes. this may well have been just one group who were there, but it definitely I understand came out of the workshop.
Where in this flow chart is the central co-ordinating office ..... yes, not represented except as the Register, which in some people’s minds could have been synonymous with a central co-ordination of regional offices or it could be there was an expectation that there would be one register for the whole country at the time this was drawn. It doesn't say national co-ordinator, it doesn't say 14 regional registers.
Is it correct that this diagram was created based on the World Health Organisation requirements for a screening programme – this is 1988 ..... they certainly had the material available to them – this was a workshop of people with lots of interests. Which I said it was difficult to achieve a consensus and different working groups drew up different models of their particular areas of interest. And this is put in for completeness, it doesn't make it a firma recommendation for anybody, but the World Health Organisation requirements you would have seen would have been some of the background of the material they'd had.
In the context of the programme over the last 10 years how much has been implemented of this flow diagram ..... implemented?
Or put another way, what is missing ..... what is missing from the current programme as it stands today?
Right ..... there's been education, access has been proved to be effective, smear-taking, there is feedback to the providers of the service, smear-reading occurs, and in TELARC accredited facilities, the results of smear-reading go to the Register, the register is linked to cytology to histology coming from colposcopy services. Smear reports go to the women and to the provider – they go to the provider with the expectation they would give them to the women, the women are advised of recall times. Normal results go back into the cytology register to be cycled around at the recommended time, abnormals go for investigation and treatment and what's missing in this diagram I guess is a follow-up if there has been no treatment after a period of time to get that women recalled into the system, they leave that cycle with the dotted line, if invasive cancer has required treatment the laboratories are obliged to put the women on the cancer register and data is correlated with the cytology register and the cytology register itself does not consist of one box in total, although it’s now an interconnected system. in those respects, the circle’s have now at superficial reading the circles are completed as is drawn there.
And when were all the elements in place, what year ..... the histology and Cancer Register linking to the main cytology group of registers and the linking of the register were 96 for the histology and cancer and later than that for the full reconfiguration to get the cytology register fully linked together – so 96.
96 with some elements, 97 ..... I think that’s how the evidence has been given, yes.
is this the usual period of time, i.e. 7 years, is that normal for the establishment of a programme ..... I don't think there are any other programmes similar to this to compare, breast screening would be the nearest and that has been another population based system, has had a long period of incubation and development. So if I am to give an opinion, it’s an unsatisfactory long time, but people have carried out their continuous improvement that they were aiming for that has been part of their being in the job I believe, so yes, it’s a long time, too long in hindsight, but other programmes do take time to bed down as well.
Other countries have put an umbrella of organisation on elements of the cervical screening that are already in place – for example the UK. Do you know how long it took them to create a National Cervical Screening Programme ..... no, I don't. I've obviously read of problems and many problems of major significance, but the time – no I don’t know – they haven't achieved it yet by the sounds of it.
Is there a central office now for the screening programme ..... yes, we have a national co-ordinator and a manager of the screening services within the Health Funding Authority who will be giving evidence soon, I hope. But giving evidence with the Health Funding Authority evidence.
And this individual can give me the information about their function ..... yes, Dr Peters has that role.
In your opinion is this a good model for the screening programme, this diagram ..... the diagram, yes, it’s what I understood was to be put in place. So, yes I’d have to say yes. I can't see where I should be adding things into it.
Yesterday we determined that the cross symbols represented quality control ..... yes, that’s what the page before it says. Points at which quality control needs to happen and evaluation needs to happen, so that’s outcomes in one or two places and points where one can put in quality control
MR HODSON: at the bottom left we've got the faintest outline of what the dagger means, but there is no way to read it.
My description of it, if there wasn’t, the page before mentions quality control points at which you can make a difference by putting in quality control measures or continuing to improve.
Do you accept an organised programme should have a quality assurance programme ..... yes, I think any project of this magnitude and involving so many people should be developed with a documented quality assurance procedure manual which can be changed and which would have the philosophy and the different roles of the different parties, how they can make a difference, how they monitor, how their work impacts on others. Yes, there should be a manual which should be adhered to which contains all the elements of a quality assurance programme
Based on what you say, is the quality assurance programme the sum of the individual quality assurance programmes of its components ..... I think yes the daggers would mean that those are the points where differences can be made and the major difference in total would be the sum of those efforts.
Is there anywhere in this diagram that you would add additional quality control ..... we haven't any feedback from the women involved, the providers, and the Register itself doesn't have a dagger attached to it, although the recall system that it runs does, so within the whole register however that’s defined should itself have a system that it is failsafe and is producing the data correctly.
Is it correct to say there is still work to be done ..... I would rather you ask the current manager of the programme, I'm sure that there are major continuing improvements that could be put into the system,..... I don't think it is right for me to say how it’s been managed over the last 2 years so I would prefer you ask the current manager what improvements are planned to be made.
In your brief of evidence you gave descriptions on the qualifications and training of individuals involved in cervical screening. However, I didn’t see similar descriptions for individuals involved in the delivery of the screening programme as defined by this diagram. ..... no I agree that is absolutely correct. I found other than job descriptions for the co-ordinator and I think a generic job description perhaps for Programme Managers early on, then there are no set and defined competencies that I could see for people involved in running the programme within the Ministry and then the Health Funding Authority and the Regional Health Authorities before that.
In 90 when the programme was introduced there wasn’t a culture of smear-taking in New Zealand, is that correct ..... no I don't believe that is correct. There was even a debate as to whether introducing a cervical screening programme would reduce the number of smears read in laboratories rather than increase it, so it isn’t true to say there was no culture,..... smears had been taking place and being read from as far back as I can find in the files. In many cases the wrong people were returning too often to have smears, but it wouldn't be fair to say no culture of smear-taking.
There is an exhibit, the Skegg workshop, I think ..... that would be fairly early in my volumes.
There were a variety of interested. stakeholders at this particular meeting and I was concerned to read the comments about primary care delivery, i.e. delivery of cervical screening and the individual being recorded I believe stated that this type of training was not being provided in the undergrad curriculum, by the medical curriculum ..... volume 2, tab 8, there certainly was a real cross section of people there. The person most possibly involved would be the Medical Superintendent of National Women's at that time – I think she was there – p46 is the Medical Superintendent of National Women's – obviously that was an area where cervical screening was difficult in that there was some anti among the staff there.
I think it comes under the education of professionals, p36, then on p38 there is the education of the general practitioners. I think what this meeting highlighted was before the introduction of the programme there was some discussion about the resource needs, the training needs of the professionals and non professionals for the delivery of this programme ..... yes.
And was there any action based on these discussions before the programme was introduced ..... no,..... I can't set out any particular actions, the college of general practitioners was involved, the educational institutes were – the two medical schools that is, staff of the two medical schools were involved, the needs of the programme were known but in fact the cervical screening programme itself did not develop a package for education of general practitioners about cervical screening as far as I know.
Are current graduates of the medical schools appropriately trained for the screening programme ..... I would expect so, but I can't define the amount of training that they have.
Who could give me that information ..... certainly the first – to be a general practitioner you go through the undergrad medical training and then the expectation is you will do a register post in general practice where there will be ongoing training and cervical screening would be one of the competencies expected, so I was thinking first the undergraduate medical schools, but it isn’t them alone, it would also be the training of the College of general practitioners and I haven't got those at hand, we could find for you what the universities have to say and what the College of general practitioners have to say about their training programme
You accept that the quality of the programme is dependent on the sume of the individual components ..... yes.
Thus each component of general practice, colposcopy all needs to have quality control in place .....– I agree they have to have their competencies defined and trained up to them and maintain their skills and be provided the educational material in which to refresh their memory.
Is this currently happening in New Zealand ..... there is no monitoring of and no examination requirements specific to cervical screening of the medical practitioners involved. They are provided with education material and my understanding is they are provided with the undergrad training and it is part of the competencies expected in general practitioner training. So I would expect so, I cannot provide the documents to prove so.
I note that in p28 of your brief, paragraph 87, that cervical smear reading is a “regular … 1989”. And it states “it can be carried out by a registered medical practitioner.” Does that include individuals other than pathologists ..... yes it does, that’s the way the law is written and has been written, and I guess that’s why I brought it to the attention of the committee, that’s how the law is written and I guess that reflects the attitude that probably still exists today in all medical specialities, having the qualification makes you competent to do work that’s medically related. You and I may not agree with that, but that’s how that regulation has been written and that’s how a lot of medical practice is carried out.
How would this regulation drive with the need now to maintain competence and recertification ..... I think I point out further on that that – although that is still there in the regulations the medical practitioner who is not a pathologist but working in a laboratory – this is hypothetical, but under the Medical Practitioners Act which came in subsequent to this, they would be termed as a practising pathologist, so they would have to work under the supervision of a pathologist; the Medical Practitioners Act takes priority of this particularly in the year 2001.
At the time the programme was introduced in 90 how many individuals other than pathologists who were medical practitioners were reading smears ..... I don't know. And I suspect it was probably none, but I don't know.
Are there such individuals now ..... not that I know of. Again, I haven't done a workforce survey to see. Every laboratory has a supervising pathologist as part of its requirement, so those individuals one would expect would be working under supervision, but that’s all hypothetical, I don't know if there are any.
Were obstetricians and gynaecologists reading smears ..... not to my knowledge.
what is the function of the laboratory assistant ..... in the case of cytology they prepare slides and they are also primary readers of cervical smears. So they are while undergng their training they would be under full supervision, then when they’ve passed their qualfctn they are primary readers and there's a responsibility within the laboratory, as I see it, and as I've read it, to define what is an abnormal they must pass onto somebody more senior than themselves in the laboratory. So, preparer of smears and primary reader.
When the programme was launched in 1990, that was around the time that there was the exposure in the USA abt substandard cytopathology practice in 1998 ..... it was around that time 98/99 when I was looking at home screeners - that would have been associated with that whole time, yes.
Did the implementation unit keep abreast of the developments in the USA ..... I can't answer that, but through their discussions with the Advisory Committee I would assume that they did, yes.
They were aware that the practice of cytopathology was suspect even in the USA ..... even in the USA. Yes, and the home screening and the high throughput were all considered as being indicators of potential poor practice, that’s why Cytology Advisory Liaison Committee was spending quite a bit of time trying to decide what was an appropriate number of smears for the smear reader to read
This would be Between 98 and 80 which it was for New Zealand a planning period ..... yes
So this information was available to you – i.e. laboratory practice may be less than perfect ..... yes
And you had numerous reports from a variety of expert individuals and groups that laboratory practice may be a vulnerable component of the screening programme ..... yes
When the visits of the Area Health Boards were undertaken by the implementation unit, there was a meeting with the local players, i.e. physicians and other personnel ..... certainly if the Gisborne one can be taken as an example, yes there was a meeting with general practitioners or a general practitioner representative who would have represented the smear-takers at the time, met with the pathologist, I think they particularly met with the Area Health Board people who were going to be running the programme locally and they may well have arranged who came to the meetings on that day.
Also there was a survey of laboratories to determine the number of smears ..... that was the one we looked at this morning as to whether laboratories could provide the information about the number of smears they were reading and the type of results that they had sent out.
Also at that time there was the 86 document on guidelines for cytopathology practice ..... that’s correct, the New Zealand version authored by 2 out of the 3 pathologists on the Cytology Advisory Liaison Committee
So everybody was aware of the needs for quality control, the negative outcome and bad media if you don't have quality control, is that correct ..... that’s correct, and that’s why fairly early on they were developing the standards which were to be used by TELARC and the two pathologists.
We are still in the period 89, the dvlptmt and planning period. If all of this was known, why when the survey of the laboratories was conducted, why wasn’t their a survey of the practices at the same time ..... I don't know the answer, that survey was, I'm sure, part of the planning process to see how data could be collected, so the person doing that had one particular task, as I would see it.
Although quality control is one component in the laboratory of a successful screening programme it was recognised before you implemented the programme it was a critical component ..... yes.
Why didn't anybody survey the laboratories for their quality control activities ..... I don't know the answer. I do know that there was an advice that was an advisory group that had been formulated on just these issues about laboratory standards and laboratory quality and how the programme would liaise with the laboratories. That was done, but you are quite right, there was no survey of laboratory quality control activities done at that time.
Was it moral and ethical to put a national programme on top of the structure that may not have been perfect ..... those are very strong words for me to have to use
As a physician can you answer ..... this is no excuse. If you say there's no perfect health care system in looking back there are many things that could have been done differently I'm not sure that I would say that it is such that it was totally unethical to use the existing services which – I couldn't say it was unethical to use the existing services, nor would I say it was immoral to do so.
But the quality of the services at that time were not surveyed, particularly laboratories but there were many other elements of the programme that in all likelihood should have been surveyed as well, do you agree ..... looking back, yes, but again if this was a totally de novo service then there are things that you would do differently. If you were adding something to actually improve the outcome of what was already existing, then I think that’s a different approach that you'd take, and so counsel of perfection is to get everything right before you start, but if it's already existing and you're going to set targets for improving what's already done you often build on the existing service. I think that would happen again to some other improvements that’s put into medical care in the country.
We have heard from some of the testimony of the first 8 witnesses that various elements of the programme may not have functioned as well as they should have ..... in varying ways for varying people, yes.
What may have been in place in 1998, i.e. not a perfect situation for piggy backing the screening programme onto may still be in place today ..... that is possible when you look at competencies of people involved, when you look at training matters, the council of perfection might still apply to care and I think unfortunately the histories we've heard show that there are points of care there, maybe not directly related to the cervical screening programme, which could have been done better, I'm sure that will always be in the health care system but we should hope to get things better and better and better
When you implemented the programme in 1990 the foundation may not have been perfect, is that correct ..... that is correct.
Was there some form of priority setting meeting to guide the implementation of the various aspects of the programme ..... I think we've heard the history and in times there was different priority setting and the biggest priority even right through to 1993 when it was handover to the Regional Health Authorities was to increase the enrolment of women from the higher risk groups and that was classed as priority number 1 as I read it. Even to the detriment of getting some of the infrastructure correct. And that was - I believe that was a priority that was set for the programme – it could have taken longer developing than an infrastructure that had more control points, so there were messages that were lots of recommendations but a major priority of putting effort into education and enrolment.

LUNCHEON ADJOURNMENT – 1.08P.M. – TO RESUME AT 2.15 P.M.
PROFESSOR DUGGAN: Just before the last break we were discussing the piggy backing of the programme onto the existing medical system. my question to you now is, is it appropriate or was it appropriate to piggy back the screening programme onto a medical system that was not audited ..... I think it was at the time the option for improving the medical service that was been provided because there were so many components of the health care system that are actually involved in the diagnosis and treatment of people who had gone through the cervical screening programme, so yes I believe it was appropriate at the time.
And in retrospect ..... at the time of 1989 I haven't got a picture in my mind as to how you would have audited all those components of the service, what standards would have been there to have been followed by all parts of the health care system which are involved in women being examined and treated for cervical conditions. You would have to have put in a system of auditing, really the whole health care system
So you had no doubts about the quality of the medical system ..... no I wish that was true. I had, from being part of it and being in the disciplinary committee, doubts about the health care system and always being able to deliver what's required, and I still have. Obviously in retrospect one would have liked to have seen a programme that’s completely freshly designed and had all those components built into it. I haven't got that picture of how that could have been done at the time.
So you had some doubts about the medical system but still the piggy backing occurred, is that correct ..... I'm being much more general, because cervical screening programme and the treatment services that follow on involve so many different parts of the health system I say I have doubts about whether health care can always provide the safety that’s required. I also do not quite envisage how at that time all audits of all parts of the health care system involved could have been put in place.
If I understand your position correctly, you received complaints with reference to other areas of medical practice ..... yes, from my role before joining the Ministry, from within the Ministry, and in my role now, yes, I hear of complaints. I have to help investigate or hear about. Things that have gone wrong in the health care system and produce press releases and so on which regrettably tell people that things go wrong in the health care system and there isn’t complete audit in what is delivered in health care.
Are the numbers of complaints re laboratory practice high low or medium ..... I believe there've been very few about laboratory practice generally, and they seem to have been at the earlier part of the cervical screening programme, there isn’t a continuing list of complaints and I haven't heard of any in the last few years. So, I tried to work this out, looking at the proportion of money spent on laboratory services, the number of people involved, I don't think the complaints I've heard about of laboratories make that a riskier service than other health care services overall.
How would the number of complaints compare to the number of complaints with reference to family practice ..... the Health and Disability Commissioner who handles most of the complaints these days, has done since 1996, reports that general practice provides by far the biggest number of complaints about health care services. It’s a guess.. I've read the figure, something like 75% or more sticks in my mind.
Would you mind going to volume 4 of your exhibits, a letter dated July 5 1995 from Canterbury cervical screening programme – Val McKliskey, who is the manager of Canterbury. This is a letter re atypical smear results and the first sentence “recently a general practitioner contacted me … had not shown up for 2 years for any follow-up.” Do you know if this matter was discussed ..... as it’s in amongst the agenda papers. My concern is, based on the evidence of some of the first 8 witnesses, such a scenario occurred. And this is a letter from 1995 that actually documents such concern from the Programme Manager ..... hmm. Yes, it’s whether you are asking where this was then discussed, and I'm not sure that I can give you the reference in the minutes at the moment.
You would agree it’s an important issue ..... yes. I do agree. I would have hoped that it was the sort of thing that was disdfcusd at the Programme Manager’s meeting as well, but that will take a fair bit of thumbg through to find
What is the liability of the register and the recall system of the general practitioner in this scenario ..... legal liability? I'm not sure that I can answer that question.
Ois there an ethical liability ..... well, anything that is a complaint should be followed up, and if there has been an error, then people should be informed that there's been an error re their care and corctv measures put in if its shown there's something wrong with the system. these are my views. What I can't in this particular case can't tell you just how it was followed up and what was done at the time.
I think the committee would like to know to what degree the Register goes in order to ensure that letters that they sent out actually get to the women and if there is no action on that letter what is the next step ..... yes, and I think the issue of letters that are sent out and what happens at the steps would be better answered by the co-ordinator manager person who’s going to come along. Obviously processes did change through the time of the programme, as improvements were put in – I'm not able to specify – it would be conjecture – we can provide the material through the Programme Manager.
I did ask Ms Glackin this question, perhaps I can ask you the same, do you know how effective your letter recall system is ..... personally I don't, so I haven't got anything in front of me as documents to refer to that would give you an answer, and that would be again a better answered properly rather than me making guesses.
This letter from the Programme Manager might indicate that the recall system was not effective ..... yes, I personally don't understand why the Programme Manager would have to write a letter, I would have thought this would be something found out about and discussed between the co-ordinator and the Programme Manager so that it would appear the first that’s heard of it is a letter when I understood them to be in easy contact of each other, but that’s again my view, I do not know what happened in this particular circumstance.
Could we turn a few pages, 14 pages, to another letter from Di Cook to Dr Clint Teague on 19 June 1995. ..... this is from Healthcare Otago on behalf of local Programme Managers for that part of the South Island.
The first paragraph goes on to say “the local Programme Managers … than usual.” ..... yes, that’s what it says.
And she asks if the committee would consider this problem. Do you know if this problem was referred to the Advisory Committee ..... it’s headed at the top “correspondence Cervical Screening laboratory Advisory Committee meeting 26/7/95”
My reason for bringing this forward is that in some of the early witnesses we may have had situations such as this ..... hmm. The notes of the meeting of that data don't include reports on a discussion.
If I understand how the registry works, the smear would go to the pathologist who has not seen the cervix or the women and would be reported as normal if there were no abnormal smears ..... yes
And the management recommendation could either be repeat at the next screening interval which n may be 3 years or maybe altered if she had some prior abnormality ..... yes, that’s what I understand
However the smear-taker – I'm not sure if the smear-taker can alter the management recommendation based on their assessment of the cervix and the report and if they alter it how is the register informed of this change in management ..... yes, and I again am not able to tell you exactly – I know this did come up as a problem and I have actually discussed it a little while back with Di Best as she is now, and again the better answer for this would come from the people who are operating the programme itself right at the moment. I would be guessing, I haven't got the documents.
So this scenario that we heard earlier in this inquiry has been documented here in 95 as a concern of the Programme Managers and I'm not sure if it has been referred for discussn any polace else ..... yes, and that will I'm sure be answered for you. I've looked at the minutes of the meeting following, there is no note in the min but people involved will be able to tell you if it was. I know that the smeartakers, the general practitioner, obstetrician can obviously override because it isn’t the register which recalls the woman in the first instance to give them their, if it’s a normal smear, to advise them about returning, the Dr could always override that. what we really want to know is whether in overriding it, if that’s Dr contacted the Register the register has a system to amed what's written in there from the Bethesda code. I can't give you the answer.
Who can gifgve me the answer ..... I believe the witness to be called, who has been a programme co-ordinator, Programme Manager.
Thank you very much.

QD BY CHAIR:
Dr Boyd if you could please turn to your volume 4, part-way in there are the minutes of Cytology Advisory Liaison Committee for 17 November 1993. ..... yes.
If you could go to p6, please. At the bottom of the page there is a heading “histology” ..... yes
Tina Handisides was teeling Cytology Advisory Liaison Committee that there were probvs of implementing histology as the wording of the legislation was less than perfect – would that be the amendment of the health act 93 ..... I'm sure that would be the case.
She continues she …. To amend the legislation but she stressed that little …the new legislation … very slow.” Is that a fair description of what the political will is at the time in respect of anything to do with the programme ..... I think it would be totally unfair to generalise anyhg to do with the programme, this was one person’s opinion and may be at that time it had as much value as my previous comment about time spent with legislation.
Well It had taken until 93 to arivfe at the legislation which allowed for the opt off programme had it not ..... well, that was the date that the health act was changed and that included the opt off and the histology requirement.
Because there had been concern about doing that without legislation in place because of patient confidentiality, is that not so ..... that was one of the reasons I understand, it was a very big issue at that time.
And had it to your knowledge come to light that the legislation might in fact be less than perfect in allowing those events to occur ..... sorry, can you ask that question again.
Did you know at the time that others within the Ministry thought the legislation was less than perfect insofar as it would allow the comparison of histology and cytology ..... no I wasn’t aware of that, and certainly see this as comment with some agreement from the chair of the committee involved, but this is after the event. No, I'm not aware whether these were expressed before the legislation was put through or drafted.
Well after the legislation was passed were you at the time aware that there were persons, includilng Tina Handisides and Clint Teague who were findiong problems with the legislation in terms of its workabty to allow comparison of cytology and histology data ..... no personally I wasn’t aware at all, it was obvslyu discussed in the right forum and the decision was made by the committee that there should be they should advocate a change in the legislation and I know no more than what's written here
Dol you know if there was a further change to the legislation ..... my understanding is no there was not.
Can you offer comment on why it is that Tina Handisides would have said that there was little political will to amend the legislation ..... no, I can't.
Continuing with this issue of cytology and histology, could you turn to your brief firstly at paragraph 36, paragraphs 1, 2 and 3. at paragraph 123.2 it lists one of the advantages … quality assurance: ..... yes.
Would you turn to paragraph 129 of your brief, there is mention there of the Cytology Advisory Liaison Committee meeting and Janet Phuah’s paper “data … to asses potential cytology and histology within New Zealand.” Firstly, do you agree with the comments in Janet Phuah’s paper ..... their comments on her paper?
Yes ..... this was the comments of an expert Advisory Committee about the paper?
Yes. ..... reading through this I was surprised that a committee of experts themselves couldn't find an expert who would be able to fulfil that role, but the committee of experts has made it, and I can offer no opiniono whether they were right/wrong
If they were of that view, how would it affect the advantge listed in 123.2 of your brief of evidence ..... I read it and I wasn’t there, so I wasn’t party to the discussion, I read it as being they were more concerned putting this data together would either discredit the programme as a whole or it would in fact give wrong information about one area v another or about the national figures. Having thought about it I still believe it would be possible and very important to correlate one laboratory’s work with particular women who had had a smear read at that laboratory and their future care and diagnosis, but I seem to read it as saying they were worried that the statistics as a whole would give a wrong impression and if used as generally published data about the programme as a whole or specific laboratories. That’s my reading of it.
Do you see it as having any detrimental impacted on quality assurance or not ..... collecting the data and correlating them I believe would have improved quality assurance in each of the laboratories that it was applied to. We seem to have agreed that’s the expert opinion through and through. So it would improve quality assurance but I was interested. in seeing this comment that they had doubts, maybe the discussion I've had with Professor Duggan about the other reports could maybe shed some light on why they felt that you can't just take these figures and publish them without looking at all the different correlations.
If you would stay with volume 4 and the Cytology Advisory Liaison Committee meetings of 17 November, p5, you will see under the heading “TELARC”. You will see imemdly under the bullet points confirmation as at that time there were 22 registered laboratories ..... that’s what it says.
You would have no reason to doubt that ..... there are some many figures tossed around in the last few days, again this is the issue because wshe was coming to ttalk to them about cytology did she mean 22 TELARC registered laboratories which are doing cytology or not, and has it been recorded exactly what she said.
I see immediately above she was asking Cytology Advisory Liaison Committee if it was wiolling to …. For histology and there is a series of issues which she deals with criteria … relating to cytology. Would you not infer from that that the 22 TELARC laboratories were those doing cytology.
..... I would think so, different laboratories would be doing the histology part, in hospital laboratories which may not do any csrs, not quite as easy to say yes as I would like.
It has appeared from the material that the Health Funding Authority will be producing it wasn’t until march 97 that the Midland Regional Health Authority signed off contract with the laboratories which included accreditation., would you consider that to be slow given that as at 1993 there were 22 TELARC registered laboratories available whose services could have been used ..... this goes back to the putting the erspbty onto the new funder and how it was in the funding agreements I did not know until told yesterday that same bit of an extract from future evidence that in fact Midland’s contracts with the laboratories weren’t signed until more than 6 months later. Do I consider that slow? I would – yes, I would, but I don't know the circumstances around it, and I don't know whether they had complied but the contract wasn’t signed, I do know there was negotiations obviously between the laboratories and the funder, this was a new system in working where they could negotiate whereas before they had representatives come to a Ministerial committee meeting. It was a new system, I didn't think it would take that long
As a public health specialist it is a matter of principle, if you were working in a health system where health clvry was being managed by way of a contract base system, would you not expect the party ultimately responsible, who was startoing the ball rolling so to speak – the Medical Officer of Health. with its contract with the Regional Health Authority, would you not expect it to include a requirement for quality control in its contract ..... yes, because they were to purchase quality and in their contract was obviously the requirement for the best endeavours for TELARC registration.
Under the funding agreement I have noted best endeavours and reasonable endeavours – do you I know hat those two terms mean ..... no, I would be guessing sitting here. That is the reason we have arranged that someone can run the inquiry through that process, how it was put in place, even perhaps the prioritising that was expected, looking back you can't imagine someone would be able to sign all contract on day one and they had to roll over some parts until the contracts were written.
I've referred you to those Cytology Advisory Liaison Committee minutes in 93 when there was reference there to TELARC accreditation. I note also in the 96 policy document which appears at volume 1 of your exhibits, at p20, this document is dated June 96, I note at p20 under the heading “quality …. Screeners” it says “to be eligible …or an equivalent aqcredn authority.” That is the first time in the Ministry’s documents that I have seen it stated as a simple request rather than a reasonable endeavours, but yet again I would ask you to comment on the fact that although the policy document says that accreditation was required in June 96 in the case of Midland it did not occur until February/march 97. do you have any comment on that ..... that was what I was answering before, I didn't know it would have taken that long, I don't know what their priorities were or how much negotiating they were doing about the contract of which this may have only been one part, so slower than I would have expected looking back on it but I did not know at the time, did not know until yesterday.
Could you go please to volume 13 of Ms Glackin’s evidence at tab 72. this is a question I asked Ms Glackin and she said you would be best to answer it. Firstly you will see the 93/94 funding agreement. If you move to 94/95 funding agreement, go to p74, if you look at 10.3 you will see there that the Regional Health Authority is to purchase cervical screening services and it said in the second sentence “this programme … 1991 policy for National Cervical Screening.” ..... yes.
Do you accept then that under this funding agreement it was based upon the agreement being consistent with the 91 policy ..... yes, I do, as redrafted in 93, because the original 91 one should be completed by 93 in it. Yes, overall, yes, the same policy with those minor alterations.
And if you could, just keeping that in front of you, then go to the policy document, volume 5, tab 15 – the original document – reprint February 93 ..... that is correct.
And if you could go please to p5. if you look under the heading “laboratories “ – paragraphs 4.1.2, 4.1.3, 4.1.4 ..... yes.
Just keeping those in front of you, the final document I would like you to go to is volume 13, tab 71, the Cytology Advisory Liaison Committee submission on the programme policy dated June 94 ..... yes.
Could you turn to the second page in you will find the heading “laboratories” and this is comment on the paragraphs in the policy, they marry up together, if you look at the comment in Cytology Advisory Liaison Committee’s submission in 4.1.3 you will see that Cytology Advisory Liaison Committee is saying “The Ministry of Health will be responsible for confirming … 4.1.4” ..... yes.
And if you continue reading you will see it says “the committee believes the paragraph should remain the same … in 4.1.2 should be substituted” ..... yes.
You will be able to see what those rqarmts are by looking at the policy document which you'll have in front of you as well. Cytology Advisory Liaison Committee continues “The reason the Ministry of Health … accreditation … by TELARC.” ..... yes.
Firstly, do you know whether or not the change suggested by Cytology Advisory Liaison Committee was followed up and put into place ..... well, obviously not in that form, because this is a submission on what new policy should contain and the new policy came out in 96, as we've heard, and it isn’t exactoy the wrodg they recommended at the itme. The philosophy is the same because the requirement is it is on to the health authority that they see that laboratories are TELARC accredited. It seems pretty pointless to have 2 bodies to do the same confirming thing.
In terms of the funding agreements of 94/95 that was operating on the basis it was to be consistent with the 91 policy wasn’t it ..... that is correct.
And under the 91 policy it was the Ministry who had the responsibility of carrying out the criteria set out at 4.1.4 wasn’t it ..... it was confirming that laboratories complied with 4.1.4. obviously, it was 0- nop I don't know o bvsly – it seem to me at the time having TELARC accreditation would comply and just confoirmg that one would be one thing, the other thing those laboratories not TELARC acrdd at that time the wording would be the mniny go around to do an audit of their own. We have heard the Ministry did not have that capabitlty and did not do it and put all its sstore in meeting the policy as soon as it thought it was able to do so in meeting TELARC registration and we have hard many times over how long that took.
You agree with the Cytology Advisory Liaison Committee vew that the Ministry didn't have the expertise to perform its functions under 4.1.,4. at that time ..... we have had to have bought in expertise, created auditors for laboratories which had never been our function and so we didn't have the capacity to do that work competently.
It would seem then that under the documentation which found its waya into the Regional Health Authority agreement for 94/95 that the Ministry was under a rsp bty in terms of those legal documents which it in fact was not able to discharge, is that correct ..... yes that is correct.
And also is it fair to say that because under the funding agreement the responsibility was placed on the Ministry it would unlikelky that any other party to the funding agreement we carry out a responsibility which in terms of the funding agreement oit was under no obligation to carry out ..... that was the confirming that the laboratories complied with those particular criteria. There was still their best efforts in getting them TELARC registered.
Putting that aside, in terms of carrying out the criteria under 4.1.4 any party to the funding agreements that didn't under the agreement have that as an aobligtn would not be likely to carry out that task would it ..... of audointg the laboratories itself, I don't know that the Regional Health Authorities or the Health Funding Authority had capacity to audit laboratories and who audits the auditors in that case.
So is it correct to say the Regional Health Authority and the Health Funding Authority would not be likely to take on a task which under the terms of the funding agreement were placed on the Ministry of Health ..... that is the auditing of the laboratories correct, which is not otally exclusive from using best endeavours to get the laboratories TELARC accredited to those standards
Are you able to comment on how it is that the ninny allowed

Funding agreements to be funded in such a way when responsibility was placed on it when it practice it did not have the means to do so ..... it has to be personal opinion and it would the 91 policy was soundly based on at the time when it was written I think there were so many things going on health reforms that somebody used a shorthand process or a shortcut process to roll over a previous policy document when some of the wrodg was probably not relevant, knowing that the Ministry was putting all its store on the TELARC accreditation. I believe a mistake was made in what was put up to the Ministry about rolling over something when there was no real capacity to carry that out. There was an expectation it would be corrected very early on – in 94 the consultation was well underway what should be in the new policy documents. With hindsight we can say how stupid to think all that would happen soon when in fact it took until 96,..... but that wsasnt the attitude of the people working at the time.
I note in terms of the funding agreement for 95/96 that replicates the wording in the 94/95 funding agreement in terms of the responsibilities of the Ministry ..... for this particular issue, yes.
And I note in the funding agreements you've made reference to the Regional Health Authority attempting to ensure that the laboratories are TELARC registered, the wording used is actually reasonable endeavours, not best endeavours ..... yes.
I am aware those two phrases are used in the fiudning agreements, do you know who would have chosen to use the phrase r/endeavours rather than b/endeavours ..... no, I don't. it was obviously that was what was negotiated between the ninny obh of the Minister and the health authorities

Who themselves wrote this part. They were given the Minister’s wishes to explain it in general terms, they created an agt that they felt they could live with which met the min’s wishes, and it was legal argument between the Minister and the Ministry and the Regional Health Authority which was then to do contracting with that money.
I note it appears in volume 14 there are Cytology Advisory Liaison Committee minutes of 23/24 July 92 and as erlyu as that it is said that under the new system of Regional Health Authorities and CHEs that the market “and Programme Managers .. for smear-reading.” ..... that never became aprogm role because the funding authority took that role on. There was considerable discussion and that whole health reform is a very interesting letter what the competitive edge hasn’t been discussed here so far, the original plan was there should be private health care plans to complete with the government’ health funding agencies to really make this a copjmetive health care system where you could chose where your health care $ were going to be spent for you, so your money could be directed to a private health scheme or government and you would pick the best one for yourself. That was in 199l2
In terms of the belief in 92 that competition would allow Programme Managers to chose laboratories for smear-reading that never translated into the benefit of choosing only TELARC accredited or any other type of accredited laboratory until late in 96/97 did it ..... no and it never became a role of a Programme Manager either. So you are quite correct in that. the opportunity was there if Regional Health Authorities had grasped it, that was I guess up to them, that was their r/endeavours and I guess we are taking it for granted all the other Regional Health Authorities are the same as Midland and I'm not sure that I know that is the case.
Did the health reforms of 93 create a great deal of pressure on the Ministry in terms of its ability to discharge other functions such as the screening programme ..... yes, there were staff who were deputed to the health reforms and so some of the better brains were put to that work and there were other disruptions to management level and there was uncertainty. But I don't know that the actual membership of the cervical screening programme was altered and I don't know that running the day to day operation was affected by that preparation for the health reforms. we have discussed whether legislation would have been easier to pass – requiring to go through the House - I don't know there was any effect.
Could you turn to Ms Glackin’s exhibit 088, one of the separate ones. If you turn to p55, the last paragraph, letter from the Minister of Health to Ms Betsy Marshall and you will see in the last paragraph the Minister says “a number of areas within the Ministry … overcome.” Is the ministers statement there a fair statement ..... I accept I must not disagree with minister’s past or present. I said I didn't know that they were afectged. Reading that I don't know how the health reforms directly involved the co-ordinator position being vacant, but if that’s what was written that must be so.
While you have that document in front of you, if you would turn back to p46 at the top right hand corner. This is a letter from Cytology Advisory Liaison Committee to the then Minister of Health dated 5 March 95, page number 46, you will see reference to the World Health Organisation identifying strong national co-ordination … programme – reference to the department’s new role, and it suggested that responsibility of providing co-ordination may be inconsistent with the department’s primary role of providing policy advicing and funding health purchases. Do you agree there was that inconsistency ..... this is before the change on 1 July that was seen definitely within all government circles as being a role that the new department when it became a Ministry would have a much lesser role in the health sector.
And do you accept the Cytology Advisory Liaison Committee view expressed in this letter that “the department’s new role would be inconsistent with what the World Health Organisation has identified as essential for an effective screening programme.” ..... yes, this was the view offer the members of the committee about what they saw happening around them, and yes they foresaw problems.
In the next paragraph it says “recently we were told that the department has been instructed … purchased by Regional Health Authorities.” I would like you to comment on how accurate is that first sentence in the second paragraph ..... I don't know the accuracy, I wasn’t there – I didn't hear that myself at the time. By the time it had got to the committee it would have gone through several sets of ears and/or hands, so it may not be a true representation and it doesn't say who instructed the department. There was a health reform directorate which was setting the proposed path. There were nministers but it doesn't say who instructed the department. So,m I'm not sure the accuracy. Obviously the funding agreements as we found di take precedence over what the programme and its Advisory Committee s would have liekdd see happen and obviously I believe took precendec over a government policy written pvsly by the Associate Minister. that is what happened. It looks like Cervical Screening Advisory Committee were almost predictding that that’s what would happen.
The statement that the department had no power to ensure local co-ordination of a programme was puchd by the Regional Health Authorities did that reflect the department’s view on what power it had to insist what Regional Health Authorities did in relation to purchas of hlth services from other providers ..... I think that somewhat understates things. It again does depend what can be put into the purchase agreement. You could say that the department or the Ministry to be could have tis ideas what the Regional Health Authority should do but unless its in the purchase agreement then it can't be enforced and that does refer back to some of the other exhibits you gave me where each funding agreement tends to role over the one before and I understand it became more difficult to change the funding agt, you had to go through a convoluted pathway to change the funding agt because people in the department wanted to change different things and the Regional Health Authorities were finding they were being besiedged by potential changtes. Many of them may h ave been with the best intentions but so if this reflects the view that we in the cervical screening programme and the Ministry staff who work with us wish this to happen but we don't have the ultimate poer to make it happen because that is the nministers’p funding agt that’s correct.
From the perspective of a public health specialist do you find the ability to implt health policies being dependent on contractual negotiations with another body and that other body’s willingns to agree to implement the policy a cumbersome way of clvrg health services ..... it is a difficult way if you have bright ideas about what should be changed, because or if you have ideas about what are the highest priority and they don't coincide with other people’s view of the highest priority.
Is it correct that as from 93 96 during that period if the Ministry of Health found itself dependent on the willingness of Regional Health Authorities to agree to perform certain requirements in the funding agreements that the Ministry being in that situation was the result of a politicl decision to structure the health service in that way ..... yes there were some situations which it was a disadvantage to have it structured that way. History will have to weigh up whether there were other advantages from that came about through efficiencies or the imposition of quality we may never have got to where we are with the cervical screening programme if those reforms hadn't come in and altered the old Social Security legislation, hadn't altered several other things. So it hasd to be weighd up and that’s for ahistorian to really decide whether it provided an impetus of immpmt in many other fields but some missed out.
To the best of your knowledge, under the system in 93/96, had the Ministry reserved to itself a power that it could use if necessary to require Regional Health Authorities to perform certain tasks ..... if we had done that would it have been better are you saying/
Did you do that ..... well, certainly not in relation to cervical screening and it wasn’t within the terms of the reforms to and in fact to require Regional Health Authorities to do things outside the funding agreements takes a Ministerial directdn which has a constitutional pathway of its own.
There has been a lot of discussion about TELARC. If you could please look at volume 2 of the exhibits which Mr Mules is to produce, tab 27 – a collection of letters written to Mr Mules – one from Medlab Hamilton, about accreditation, and this is just the comments on TELARC “It is true … audits”. in sofar as providing an audit of a labs work does TELARC go far enough ..... I believe that TELARC accreditation is a valuable indicator of the laboratory’s capacity to do what it sets out and offers to do. It doesn't give a total assurance that there will be 100% accuracy or that the patient’s safety is always guaranteed.
PROFESSOR DUGGAN: does it assure accuracy to a certain standard ..... it asures that the standards are there and are known by the staff and that there is a checking system which will pick up some inaccuracies, but cannot garnatee to pick up all of them – no it dsnet guarantee 100% acurancy. I don't think any auditor could do that because someone could come to work one day incapacitated and try to work and could make mistakes.
So that I can be clear on this, TELARC reviews laboratories and checks performance against a set of national standards ..... no, my understanding and I also understand that TELARC itself is going to appear before the committee, but my understanding of auditing generally is they look to the processes to see are the appropriate standards available in the service bg auditied – a laboratory – are the standards there, are they known by the stdaff, is the work pfd to those standards, what checking is there done in the laboratory to see that that’s the case, what are the processes and that includes what are the competencies of the setaff doing the work, which should be within the manual, the quality manual of the laboratory, and then look at the equipment, look at the general suroundoings and make comments sometimes they are comments for improvement to bring you pu to auditable standard, other comments must be “does not meet standards at all.”
TELARC does not look at the results of the internanl quality control ..... that’s where I'm not absolutely sure. They were to be provided with even the documents that go to the laboratory that they're going to audit. As far as their comparison lf laboratories results they would want to see exnmples of how this material is used, but no they don't go rechcecking slides or checking work to see that it is 100% accurate or apply their own accuracy, they what to see that the tools are there and being used in the laboratory.
Besides the data generated by laboratories by the registry, laboratories generate other data out of their ointernal quality control methods ..... yes. such as a moisrdg is picked up by the more senior person it was referred to or picked up during the 10% screening or ztype, I'm quite sure the TELARC process wants to know when that information was found what was done with it, what is your system, did you then do a more intensive re-screening on that particular inedivd, what's the evidence they went for reeductn, what are your processes, were they put in place when you did find an error within your system or a failing within your system. that doesn't mean that they re-read the slides again as some poelple think that is what auditn is about.
But TELARC would look at the 10% re-screening for example ..... certainly yes I would hope but much more than that, they would want to know what is your system of rescreening, show us it it is working, show us some documents of your most recent series, show us what you did about that, did that comply with what you set yourself as targets.
Each laboratory sets its own targets for false negatives ..... they I believe they set their target as to what is an abnormal which then gets passed on. I can't answer that question specifically – I guess they use targets in a more quality assurance role, you've picked me up on something – I don't know whether they do or don't.
TELARC will be able to give us information on this ..... what they would look for in that area and what they would expect to see and I'm sure the pathologists would be able to answer that as well.
It is unclear as to whether TELARC uses the results of certain performance indicators in its registration process ..... it’s uncertain exactly how they apply them at the moment.
CHAIR: if you could turn to Ms Glackin’s volume 3, tab 11, a Cervical Screening Advisory Committee meeting of 12 December 91 – if you go to the second page under matters arising, you will see the reference there to Dr Teague following up a complaint about quality of smear reading at a laboratory ..... right.
And it seemed that the New Zealand Society of pathologists at the time in 1991 were supportive of a scenario occurring where if the laboratory complained about .. TELARC registered that the cervical smears taken as part of the national programme would not … after 93.” ..... yes. that was the statement, and that was obviously the expectation based on the 91 policy.
Is there any reason why this couldn't have been put into action ..... I guess we go around the circle again. This was his expectation in 91based on the policy written in 91. by the time it camne to 93 the responsibility became that of the Health Funding Authority – the Regional Health Authority as from 1 July and the government policy of 91 appears to have been overwritten by a purchase agt signed by the Minister in 93 that then required reasonable endeavours for TELARC acrdn and funding which had been the tool for cervical smears going to laboratories at that time. It was jno longer the responsibility of the then Ministry of Health.
Given that it seems that in 91 the Society of pagists would have supported an approach where someone who wasn’t accredited by 93 no longer got cervical smears from the programme to read, why wasn’t a tougher approach taken by that I mean there doesn't seem to have been any factors which would have made it dflct for the Minister of Health and the Regional Health Authorities to have taken a tougher approach with laboratories who owerent accredited after 93 ..... ik don't want to be picky but you have made an assumption, it’s in the same paragraph. You have assumed that the next statement is that of the Society of pathologists, it may well have been but I can't say that it was.
Certainly it seems that this approach was supported by Dr Teague wasn’t it ..... certainly and he was as you know was a member of both committees and was an adviser right the way through fgor the Ministry and so he was aware of what the department’s expectation was in 91, i.e. no TELARC registration, no cytology.
From your knowledge at the time, were the laboratories resistant to compulsory accreditation in order to be able to read smears associated with the programme ..... there's little in the evidence to suggest that there was reluctance, but obviously we did have a quotation about costs resources, time in previous XXN.
It’s just that it’s difficult to see, given that there seems to be little evidence in the documents so far of a strong resistance by laboratories to compujlsory accreditation in order to get contracts to read srs for the programme, it’s dfcltd to see why the requirement of the 91 policy ultimately with the new health service was changed to one of being rsble endfvrs to have laboratories accredited ..... I couldn't agree more. It’s not in any of the evidence that I could put forward. and nor is there evidence as to whether there really was resistance, whether some laboratories did not wish at any time to be involved with TELARC.
As a public health specialist given the senarioi that I've just outlined what conclusions would you dcraw from that as to the wililngns at the tme to impose compulsory controls on laboratory accreditation ..... at the time this was written, which is 91, compulsion was implicit in the policy and it was fully expected that given the 2 years this would be in place. So therefore there was no need to put some other belt and braces type legislation through, came 93 when there was still half a year to go and it was handed over to the Regional Health Authorities that obviously no legislation was drafted as you've already elicited and it was part of the funding agreement as we've gone through before.
F m youe expertise as a public health specialist are you able to draw any conclusions from why it wouldn't have been made a greater priority in the funding agreement given the scarcity of evidence to suggest the laboratories w3ere strongly resistant to accreditation being compulsory ..... no, I'm not able to decide how things were prioritised as to what must be in the funding agreement, what must have indicators. I have said some points did have indicators, the enrolment of women and the colposcopy waiting times, these were seen as critical for the success of cervical screening but why this particular one wasn’t given the same priority is not something I can tell you about why.
Thank you.

PROFESSOR DUGGAN:
If you could go to p29 of your brief, paragraph 94, the item with reference to the laboratory assistants. The laboratory assistants do primary screening, is that correct ..... yes.
How much of the primary screening in New Zealand is done by the laboratory assistants ..... I can't answer that question, I don't know.
Could you speculate ..... no. that’s another thing I'm not allowed to do, but in this one I would be jmisleading you. my ethics doesn't allolw me to speculate.
This group of individuals work under the supervision of the medical laboratory technologist scientific officer or medical practitioner ..... yes there is that word seitnifc officer in there, I'm not sure any more sieitific officers have been trained. I couldn't find much about them. They are very similar to the medical laboratory tecnololgists degree course people. They are more highly trained than laboratory assistants.
This group receives certictn from the New Zealand institute of medical laboratory science ..... yes.
Are they then members of that national Society or do they have a national body ..... again, it’s something I can't answer specifically. They are not a registered health profession like the tecnologists are. Tecnologists are rgd health care providers by having their own piece of legislation so they have greater indemnity powers and it’s not for me to give you oa lecture on ACC and the no faults insurance scheme but they are covered under medical misadventure for the ACC insurance scheme. Laboratory assistants are not. So they are not a registered profession, so that’s a legal standing. Whether they have a body of their own to represent themn I'm not quire sute. Certainly they have representatives at our meeting but whether they have a professional body of their own I'm not sure.
Are they then required to maintain comptence ..... the laboratory which employs them would be is expected to maintain their competence but no there is no legal requirement for them personally to maintain their competence to stay on a register because they're not on a register.
Are there national competency standards for this group ..... there are the competency standards for laboratory assistants that we discussed earlier that were drafted to be sent to laboratory managers and again I would expect it to be part of the TELARC auditing to see that there are ways of maintaining the competence of the staff from [pathologist down to laboratory assistants so there is no central governmental requirement on an individual laboratory assistant to set what their coipmetence level is there is a requirement through the TELARC registration that their staff maintain competence and that they provide them the ways with which to do it.
Is the remuneration level in terms of % and cents of the laboratory assistant equal to the tecnolgoist ..... I'm not it’s not. There's no set pay scale as most of this is private laboratories but we can make an absolute certainty that the degree course people would get higher salary because part of their job is to supervise the laboratory assistants so it would fllow that they are on a higher salary.
Is there any conern in the medical practice that primarty screening to some degree is done by this group ..... not that I know of, in that that’s the system that I know has operated and yes, I'm not in a position to know whether that’s different to other countries or other cervical screening programmes that the next step up is the degree decrease technologist who does see themselves as having a supervisory role, not necessarily of other degree decrease people but also of laboratory assistants.
MR HODSON: re the paper produced by Ms Janes. GRB/MOH/ 048
MR CORKILL: when this document was sent to myself and counsel assisting the names were deleted. Any use this document might have is compromised by not knowing a) the identify to the laboratory or b) the region from which it comes. I would like to raise this issue with the committee and with the Ministry to ensure that the full schedules are available to the committee so that its value can be properly assessed.
MS SCHOLTENS: as far as the information being presented to the inquiry, we are in the inquiry’s hands, in terms of the Official Information Act we thought it prudent to approach the material in this way. Because the association of community laboratories may have something to say about it.
Mr COLLINS:
Without knowing the identify of the laboratories, I can't take any instructions .
MR HINDLE: the document is current as at 1996 and I have to say I have some sympathy without knowing what the names of the laboratories are. The information is really of some historic value – I support the submission made by Mr Corkill on this issue.
MS SCHOLTENS: my understanding this information came straight from the register and laboratories are compelled to provide it. I understand that the Ministry were making enquiries of each laboratory to ascertain to whether they had any objection to the information being made available and obviously if it’s going to be of assistance I could find out where that process is up to and advise Mr Collins.
CHAIR: I am reluctant to require it to be distributed without hearing from the laboratories.

MID-AFTERNOON ADJOURMENT 4.10P.M. TO 4.25 P.M.
MS SCHOLTENS: I am reliably advised that there are at least 2 laboratories that were very concerned that this sort of information might be made public, the potential for misunderstanding that goes with it, and thinking that point through a little further, certainly I think there would be some hesitation in putting it out in the public domain as is.
CHAIR: the document was first sought to be introduced by Ms Janes, so given that she hasn’t produced it, if I could outline the basis for why she is producing it we can work from there.
MS JANES: Twofold: one because the statistics were falsely reassuring because there was no comparison with like regions with like regions in relation to demographics and socio economics. The second basis is that document is the only document which would enable the committee to address terms of reference 3 which is was the Gisborne laboratory issue an isolated case.
Mr COLLINS: Can I suggest that the question of individual laboratories be deferred. I understand the Ministry has raised with the individual laboratories specifically whether or not the individual laboratories consent to this information being made available, and until we understand the results of that inquiry it would be premature.
CHAIR: We will accept provisionally the sanitised document, Mr Hodson can XXN on that. it seems from what I have heard from Ms Janes that we could get away with identifying regions rather than naming laboratories. It would be subject to strict suppression orders that the information will not go any further than that.
Dr Boyd, earlier on you were asked about the information provided concern drb’s laboratory and you described that information as falsely reausring and I think you agreed with Professor Duggan earlier today that the information was not meaningful ..... without all the qualifiers that could be put to it and Professor Duggan presented some with great clarity.
Looking at that document now, once the regions and the names of the laboratories w3ere available, what would you say about the quality of that data, would it still be subject to the same limitation ..... what applied to Dr Bottrill would certainly apply to all the other laboratories, the same qualifiers, and there may be others – I happen to be privy to the letters to the two laboratories I know of who opposed the release of their names. Their view was similar to Professor Duggan’s but they certainly would want it to be known that there were qualifiers you should use before comparing one laboratory against another
And It would be correct for the committee to uplift what you said in respect of the questions about the Dr Bottrill information and impose that on what you might think of the information relating to all the laboratories in that document ..... it would apply to each and every laboratory noted in here.

XXD MR HODSON:
This document shows the analysis performed by the register from some 30 laboratories relating to their screening to 30 June 94 ..... that is correct.
Of those 30 laboratories 20 are community laboratories and 10 are hospital laboratories and in my questioning I will disregard the 10 hospital laboratories.
Of the 20 community laboratories Dr Bottrill appears, or Gisborne appears, and it’s easily identifiable because it is the only one that read 1.2% of the national smears. His reporting rate is 0.6% ..... if that’s the same as int he evidence I presented.
What this document shows is that 5 other laboratories had a reporting rate of 0.6% or less ..... having looked at these before I'm sure you are right, yes.
And taking those 5 plus Dr Bottrill making 6 laboratories, they covered 1/3rd of all the smears reported in that period . ..... I’ll take your maths as correct.
Dr Bottrill has come under very heavy criticism because the Sydney re-read of his smears came up with 3.73% high grade – i.e. 6 times the rate found by Dr Bottrill. My question is: have the laboratories which also had a rate of 1/6th of the Sydney rate or an even smaller fraction been identified in the context of excluding or establishing the possibility that those populations are at risk to the same degree as Gisborne women or more ..... there's one bit of that question I'm not sure about and that’s the 1/6th Sydney rate, you were quoting that as a Sydney rate for smears collected in this Tairawhiti region, obviously the other laboratories were slides taken in other regions. I'm not quite sure on that part of the question, but I have answered you before that the Health Funding Authority has had the responsibility for looking not only at the re-reading of the smears from Tairawhiti but also looking at ways in which you can judge the effectiveness and the quality of work from other laboratories. I've been party to their informing the Minister of what they were doing and their progress but I have no written reports because their work isn’t completed yet.
What happened in Gisborne, based on the Sydney results, has been presented as a serious public health risk to the women of Gisborne. Isn’t it desirable that the risk be dealt with as a matter of high priority ..... I believe it is being dealt with a matter of high priority and the report will be made available tot this inquiry as soon as it is complete. Incomplete reports are not helpful to the public confidence or in fact to the women themselves who've had smears.
The same comment could be made about Gisborne laboratories, but would you accept in the documents so far made available to the inquiry there is no indication of it having been dealt with throughout 99 ..... that is correct because the Ministry has not been the party dealing with it, it’s a health funding issue to be doing the investigation of what we've heard described as terms of reference 3 for the inquiry. The Health Funding Authority did want to know are there risks that the same might have occurred in other areas, and obviously re-reading smears might be one way of doing that work but there are other ways of assessing the quality of the work and much better you hear from the public doing the work.
The social demographic profile of the community would be relevant. Is it not part of the Ministry’s functions to monitor a public health concern of this nature and be aware of what is being done ..... yes it is. It is certainly more the role of working with the Minister to see that the work is done in the most effective way within the min’s portfolio and clearly it was agreed by the Minister and the two government agencies involved that that work be carried out by the organisation which currently has the cervical screening programme within its mandate.
I pointed out at least 3 times that there is no indication that this issue has ever been raised with the Minister ..... yes, you have said that, and I think certainly – I don't know why there is no particular document there. I believe that the work being done by the Health Funding Authority is not secret but it is equally not useful until the results are known and then critiqued.
Is it fair to say that exactly the same comment can be made about the criticisms and general descriptions of the work of Dr Bottrill ..... I believe very similar comments could be made about you shouldn't judge something until you have all the information. And that I hope is what the inquiry is going to develop for us.
Thank you very much Dr Boyd.
MR MURRAY: I think it would be helpful to the inquiry that the importance of that topic is not overlooked, the Health Funding Authority is doing a great deal of work and it is not going to be productive for us to come to the inquiry with that evidence – the work is being done, it will be briefed before July and it will be of assistance.
CHAIR: we will accept this document provisionally now and later we may replace it with a document more informative. Perhaps if we could revisit that issue on Tuesday morning. – GRB/MOH/ 048.

DR BOYD RE-EXAMINED BY MS SCHOLTENS:
Dr Boyd, can you turn to your volume of exhibits 5, document 26, my learned friend Ms Janes took you to this exhibit this morning and asked you a number of questions about the survey that your evidence refers to this being an extract from ..... yes
Can you confirm from the cover letter 4 May 990 that this is a request for information carried out in 1998 ..... yes, that’s what the author of the letter which went out to the laboratories certainly put.
And at tab 27 do you understand that to be tables prepared from the information received from both the 88 and 90 surveys ..... I think that is the case.
And your evidence is that those figures did not necessarily provide meaningful information, I think in particular table 8, the % of smears reported is inadequate ..... yes, I was loathe to give an opinion, but I do not believe that this data, knowing how many laboratories did not respond or found it difficult to provide the information, I do not believe this was adequate for doing the sort of assessment that people may wish to apply to say the 1996 document we've just talked about.
The next reference to statistic information of this nature is in the first statistical report which is Ms Glackin’s exhibits volume 6, tab 26. ..... yes I have that
Can you first confirm that this is the next collation of statistical data that we have a record of ..... yes.
And the data apparently runs to, from the foreword, up to May 1992 ..... yes.
And do you know the qualifications of the authors ..... two of them, yes. Brian Cox was a member of the Cervical Screening Advisory Committee and an author of several of the documents that we have already presented as exhibits and I s an epidemiologist at that time working with Professor Skegg in his unit in Dunedin and Clint Teague is Dr Teague the pathologist on the Cytology Advisory Liaison Committee and was an adviser to the Ministry.
I want to take you to where the statistical report is discussed by Cytology Advisory Liaison Committee, your volume 4, tab 18. Could you find the minutes for 10 April 1992. ..... I have it.
Can you turn to p7 of those minutes. The item which is marked B national cytology register statistics, does that appear to be – read that to yourself, does that appear to be a discussion about this statistical information prepared for this report ..... yes the timing is right for discussing, I think, a draft of that statistical report and two of the authors certainly were present.
And it notes at the penultimate paragraph on p7 that the document includes statistics able to be collected on … of laboratories nationally, and the committee discussed what should be done with the individual statistics and the action to be taken and who by … from the national statistics. Do you see that ..... yes.
And the emphasis, the minutes record, should be educative rather than punitive approach to any outlying laboratory ..... correct.
They also suggest they also be produced every 6 months and initially be supplied confidentially to each laboratory ..... yes.
And that Cytology Advisory Liaison Committee have the ability … consistently outlying ..... that is correct.
And then there is a concern that the information not be published ..... that is correct.
And that seems to relate to table 6 ..... yes.
This discussion is in April 92 and the report, the statistical report which we've just looked at dated August 92 was released in August 93. can you confirm that ..... yes I can confirm that's what it says on it.
You were referred in XXN to a meeting of Programme Managers in July 1992 where discussions about laboratory statistics were raised and Gillian Grew was to provide figures for Programme Managers do you recall that ..... yes.
Can I get you to turn up those minutes in volume 14 of Ms Glackin’s exhibits – somewhere near the middle – 23/24 July 1992 is the date of the meeting. The minutes are, I think, 9 pages long and then there is an action plan ..... yes.
The second step is that the Department of Health agreed to provide Programme Managers with the average against which they should monitor the smear results from laboratories ..... yes.
And then follows a discussion on p1 of the minutes, Gillian Grew referring to Brian Cox’s study ..... yes.
Is it fair to draw the inference those that appear in the statistical report ..... yes, it is. I understand that the statistical report’ was provided to Programme Managers and that would seem a reasonable assumption.
PROFESSOR DUGGAN: this is 92 you are talking about
MS SCHOLTENS: yes.
PROFESSOR DUGGAN: when there were 14 independent registries
MS SCHOLTENS: that is right. There were 14 separate regional registers when this first statistical report was produced Dr Boyd ..... It was discussed in 92, published in 93 and the time it was discussed at Cytology Advisory Liaison Committee was very similar to the time the Programme Managers meeting were also discussing the same issue and they were promised the data. This is the first statistical report of the data.
So the Programme Managers are discussing this in July 92 shortly after Cytology Advisory Liaison Committee has looked after it. I now take you to where Cervical Screening Advisory Committee has a look at this information, and that is in Ms Glackin’s volume 3, minutes of 11 February 1993 – near the middle. Can you look at p2, item d, statistical report ..... right.
And you see there that the chair enquired about its release and we know it hasn’t been released, reference it has been sent to the Programme Managers, Sue reiterated that it should not be widely released … summary statement … and also agreed that regular statistical reports are required ..... Yes, that is correct.
The figures in the statistical report in 92 – perhaps if I could show you two documents before I ask the question: I am really trying to follow the line of the information that the register was producing and how it was made available to those significant players in the programme, hopefully it will become clear as we move along. The one page document is an agenda for a meeting ..... I've got lots of copies of a one page document, which means counsel haven’t got any!!
The one page document you have is an agenda for a National Cervical Screening Programme laboratory meeting ..... yes, that’s what it’s headed.
And dated 1 October 92 ..... correct
And does that appear to be a Ministry file reference in the top right hand corner ..... yes definitely a cervical screening programme file number.
Number 5 on the agenda, laboratory statistics generated by the National Cervical Screening Programme followed by general discussion with Dr Teague’s name beside that item ..... yes.
The next document again does that have a Ministry file reference on the top?
Agenda produced as GRB/MOH/ 049
The next document is a Ministry reference ..... yes, on the same file
Does that appear to be the minutes of that meeting ..... yes.
Do you note among those present M Bottrill ..... yes, I'm aware he was at the meeting, I haven't found it yet. Yes, I do now, yes.
Can you turn to p18 of the minutes, where we come to item 5 on the agenda, laboratory statistics. I will just give you a moment to read the minutes under that heading. ..... yes.
Would it be fair to conclude that this meeting may be the result of the discussion at the Cytology Advisory Liaison Committee meeting that we referred to earlier on 10 April 1992 where that committee discussed how one would deal with this sort of information with laboratories when they discussed the educative rather than punitive approach and how they might deal with outlying laboratory issues – the first two paragraphs of the minutes under heading 5 there seems to be some consistency there with what was in the minutes ..... yes, you could draw that assumption. I don't remember finding anywhere else a particular reason for the meeting except there were some very important issues also discovered about revised treatment protocols and revised Bethesda coding so to bring this to all the laboratories involved must have been a very useful exercise for the programme to have them all together.
Can you produce that document, please – exhibit GRB/MOH/ 050. Are meetings like that, to your knowledge were meetings like that unusual ..... they were certainly not a regular occurence to get all the laboratory people and the committees and the cervical screening programme staff including the contractor who was working on the histology exercise all together in the same room would be a major logistics exercise to get them there, so not common at all.
Can I ask you to turn to the second statistical report which is in Ms Glackin’s volume 7, tab 37, you have been referred before in evidence to the author of this report, Maryann Linton ..... yes, that is correct and I stood corrected as to who was the author
Have you been able to find out her qualifications ..... I did rang Marian Linton to find out the information and her qualifications are BSc from Victoria University with the third year papers in statistics, 12 years in the health sector as a health data analyst, and she has attended epidemiology course in Italy, I believe that would be post doing this particular work and she’s still employed in that type of work in the Ministry. I've described it as demography and she said her role is mostly health data analysis.
This report was published in October 1995. would it have been usual to have been peer reviewed ..... yes, I'm sure it would have been and I do know that it was also subject of a part of the meeting of the Cervical Screening Advisory Committee where the author – two authors of the first statistical report were present.
The laboratory statistics that you produced before the adjournment, or just after provisionally as your document 48, those statistics are based not he same data as this second screening report – second statistical report ..... yes, it was the same author, using the same data base
And its data to 30 June 94 in both cases the statistical report and your exhibit 48 ..... correct.
I want to take you briefly to where the second statistical report is discussed by the expert committees, first to the general expert committee, Cervical Screening Advisory Committee, that’s in Judy Glackin’s volume 4, 1 August 95, 2/3 through, and the heading is in a square box ..... 1 august 95?
Yes - page 3, heading “statistical report” Maryanne Linton joined the meeting, Cervical Screening Advisory Committee … for the next statistical report ..... yes
Tina Handisides the coordinator at the time will send … of the statistical report including the laboratory data for Cervical Screening Advisory Committee … in writing .. 11 August ..... correct.
We don't have any further information about what comments were made in the documents you've considered ..... no.
Then Cervical Screening laboratory Advisory Committee in your volume 4, tab 18, the very last document is the minutes of the meeting, the final meeting, 19 June 1996 ..... yes.
If you look at p7, item 11, national laboratory results analysis ..... yes
Can you confirm that this is a reference to the information that you've tabled in the sanitised form as your exhibit 48 ..... yes, the timing is right and yes I understand that to be a discussion of all those reports from laboratories.
And she is reported as saying she has done an individual … analysis ..... correct.
And … was very useful ..... that’s what the committee said.
The data … as a quality measure for laboratories ..... yes
And there is a record that Maryann asked … format etc ..... correct.
TELARC will be given the national … data.” ..... yes
TELARC will be informed when the individual laboratory data has been sent out ..... correct.
And the individual … with the laboratories performance ..... that’s what was written in the committee minutes, yes
This is what Cervical Screening laboratory Advisory Committee envisaged would happen with data of this type ..... yes
Then there's reference to the information … internal quality measure to TELARC .. and to the Ministry … to the attention of the Regional Health Authority ..... that’s correct.
And this initial document can be used as a benchmark ..... correct.
And the action was for the programme to forward the information to the laboratories ..... that is right.
And we know Ms Glackin advises that is what she did ..... yes with a covering letter she signed.
I want to turn to the issue of quality assurance in a more general way, in particular the Ministry’s obligations under the Ministry policy ..... yes.
In 91 and then 93 and then 96. Your volume 4, 3 pages in on the very first meeting of Cytology Advisory Liaison Committee on 18 April 89, there is a reference to – the first 3 pages relate to terms of reference. Dr Boyd can you turn to the last page of those minutes, which is p5, agenda items for the next meeting, and what Cytology Advisory Liaison Committee have proposed to do there under paragraph A ..... yes, they were
”to look at their meeting at quality control including a … presently available in New Zealand and their usage, their developments at present”
That was to occur at the next meeting. If you turn over the page there is a reference to the meeting being brought forward and you can see the explanation on the second paragraph as to why that occurred ..... it was brought forward at the behest of the Health Department. “The department have requested the earlier meeting … before the end of July.” And that was July 1989.
Can you turn over 2 pages to the minutes of the second meeting on 18 July 89, p2, item 3, quality control. Can I just ask you to read to yourself the minutes under heading three which continue over on to p3. ..... yes.
Does that record advice being sought by the programme from the expert committee about quality control issues ..... yes, it does. It’s in a very shorthand form and difficult to understand this long after it was written, but yes definitely records the fact that we already know that the department wanted committee to discuss these issues and the issues are noted.
Would you agree there are a large number of issues raised surrounding laboratories ..... yes.
On p3, paragraph 3, there is a reference to the paper on recommendations and quality control produced by the Fitzgerald committee, can you confirm that that is the document that you produced in your papers in which Professor Duggan referred to yesterday as the American paper ..... yes, I'm quite sure this is the same document and I would point out the two authors of the New Zealand version were both members of the Cytology Advisory Liaison Committee and so they were part of this discussion which said this paper should be modified and taken bo the Cytology Society before its next meeting. And it should also be made – “recommendations and standards … and to TELARC.”
They wanted to do more with that paper in terms of quality control ..... certainly they wanted to look at it again and revise it before recommendations could be made, for instance to TELARC about standards.
The next document in your bundle is an agenda for the 4 May 90 meeting. ..... correct.
That’s followed by the minutes which I think we've seen on p3 which set out the discussion which ultimately found its way into the recommendations published by TELARC in 1991 ..... that is correct.
MR HODSON: the document I think we are presently looking at is headed “Minutes of meeting 4 May 1990” and lower down it says minutes of 18 July 90 were accepted as a true and accurate account.
CHAIR: do we know the correct date ..... quite clearly the previous meeting had been held on 18 July 1989. the day and the month were correct.
MS SCHOLTENS: so the minutes record on p3 and 4 the decisions relating to quality control and at the foot of the reference on p4 above the heading National Cervical Screening Programme the action that was going to be taken was agreed, do you see that ..... it was agreed that Clint Teague prepare a draft submission to TELARC. Which action?
That’s the one I'm referring you to ..... yes, and the draft would circulated to members of the committee prior to its submission to TELARC.
And just a further 3 pages over is a letter to TELARC, dated 15 August 990, signed by Clint Teague, recording those matters ..... yes, as I remember it was word for word or almost word for word with those discussions .
Can you go back to the minutes that precede that letter, p4 under the heading National Cervical Screening Programme there is a reference under “:circulation of slides” can you tell us what this is about ..... this of course is another quality assurance measure where laboratories share slides amongst themselves and circulate them. We've heard of the college of pathologists programme, certainly there were more than one programme like that operating in New Zealand in the late 1980s and into 1990 to my knowledge, and it was clear the cervical screening programme was putting to the committee that this was a good way of quality control and ensuring uniformity of reporting.
Over the page, p5, there is recorded at the top what the committee ultimately agreed it would recommend to the programme ..... It was agreed “that the committee would … using the Bethesda system in due course .. registered. while the programme was saying circulating slides was a good form of quality control the committee was saying that a closest degree of uniformity could be obtained through a uniform reporting system and TELARC registration.
The use of the Bethesda system was taken up by the programme as you've said before, that’s right ..... yes, and I think it was subject of discussion at that previous meeting that we skimmed across.
From your reading of the papers are you aware of the level of effort that went into seeking to ensure uniformity of reporting by laboratories, by the programme and its advisors ..... yes, there was a considerable amount of effort put into one ensuring that the Bethesda system was suitable and compatible with the New Zealand laboratories and in trying to persuade laboratories to all use this system as against some of the other methods of reporting that they were using at that time. And it definitely did become universal by the time the programme was up and running.
Could you comment on the importance of uniformity of reporting by the laboratories ..... the Register would be impossible to operate if it didn't have a common form of reporting from the laboratory. So that these results could be coded.
Do you know if this was easy to achieve, by this I mean uniformity of reporting by the laboratories to the Register ..... I'm not sure how to answer that., there’s definite resistance during 1990, but I'm not sure ii can answer just how difficult it was.
Do you know if it was achieved quickly ..... there must be an answer in my documentation, I don't know what the answer is.
You think there may be an answer in your documentation is a fine answer, Dr Boyd. Then just under that reference is a heading “other external quality control measures” can you just read that and let us know what other advice was given by Cytology Advisory Liaison Committee to the programme at this stage – the minutes of 4 May 1990, p5, heading 2 ..... yes, that’s very similar to the wording that ended up into the TELARC document that was circulated to laboratories
The advice to the programme was what ..... that the programme and TELARC should be advised that participation in external quality control programmes should be encouraged and before that there were some comments on the fact that there was no totally satisfactory programme of external quality control.
I now ask you to stay with that bundle and go to 17 November 93 minutes, which madam chair took you to earlier this afternoon, just before the middle, p5, item 8. in your answers to questions from the chair you explained that it appears a member of TELARC came to the meeting ..... that is correct
To request revised standards for laboratories ..... yes.
This is in late 93 ..... yes, that is correct.
Can you turn to p6, the TELARC has indicated they would provide copies of other country’s standards ..... yes
And then there is the agreement of the meeting recorded, that they would developed min standards ..... yes
Do you know what that means ..... I think it goes possibly back to the very first page under tab 18 so we had the Royal College of Pathologists of Australasia, the New Zealand Society of Pathologists, the New Zealand society of cytology and the New Zealand institute of medical technologists. They were the four sponsor organisations at the beginning of the Cytology Advisory Liaison Committee and there were representatives of each of those bodies on the committee.
CHAIR: whereabouts in volume 8 ..... the first page of 18 – the terms of reference and it gives a history of how the committee was formed, how it did its work, how it became adopted by the Ministry.
MS SCHOLTENS: so at this stage the Advisory Committee embarks on a revision of the 91 standards ..... yes, obviously agreeing that it needed consultation throughout the sector, through the sponsoring organisations.
The next document in the same volume is minutes of 24 June 94. ..... 29 June.
Sorry, 29 June, p3, recommendations for TELARC standards ..... yes.
You see the agreement at that meeting that each person on the committee prepare a different section and return them to the Ministry of Health for collation and the topics have been divided up between members of the committee ..... that is right. Clint and carol had agreed to be the lead people and they were splitting the work up amongst committee members.
These minutes are 29 June 94. we know at the same time as this the same committee was being asked to make recommendations on the review of the cervical screening policy. ..... yes.
Do you remember being taken to the document recording their view on the review of that policy ..... yes.
That document is in Ms Glackin’s document 71, do you recall that it was pointed out to you that there was a decision in that effectively recorded in those recommendations that there would no recommendation on minimum numbers of screenings for laboratories ..... yes that was pointed out in XXN previously yesterday I think.
So that was about the same time, June 94 ..... yes, they were looking at rewriting the standards, also commenting on the policy, recognised that the policy had something about min numbers and they found it impossible to come up with a number. That’s my summary of what I saw.
THE HEARING ADJOURNED AT 6.00P.M., TO RESUME AT 9.30A.M.
FRIDAY 28 APRIL 2000

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