Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region

6. Term of Reference Three

Whether or not the under-reporting by Dr Bottrill was an isolated case rather than evidence of a systemic issue for the National Cervical Screening Programme?

6.1 The Committee considers that the under-reporting by Dr Bottrill is evidence of a systemic issue for the National Cervical Screening Programme. It does not consider that the under-reporting can be seen as an isolated case of error on the part of Dr Bottrill. In reporting on term of reference two, the Committee has set out the factors that it considers are likely to have led to the under-reporting. Many of these factors relate to flaws in the Programme. In essence, the Committee’s view is that a well-designed, soundly based and well implemented screening programme would have eliminated those aspects of Dr Bottrill’s practice that were responsible for the under-reporting. The practices followed by Dr Bottrill, and on rare occasions others at Gisborne Laboratories, would either have been replaced with better, more appropriate practices or the reading of cervical cytology at Gisborne Laboratories would have stopped. In either event, the risk of under-reporting would have been reduced. Smear tests would either have been read at Gisborne Laboratories with improved practices or they would have been read elsewhere at laboratories with better practices.

6.2 Dr Bottrill does present as an extreme case. The Committee is aware of no other pathologist at a community laboratory who was practising in quite the same way as Dr Bottrill (and the locums Gisborne Laboratories employed from time to time). However, the evidence the Committee has heard has convinced it that the issues relating to the under-reporting at Gisborne Laboratories extend beyond the practices adopted in that laboratory. The Ministry of Health submits that Dr Bottrill’s method of practice was unlike that followed by any other pathologist and, therefore, it constituted an isolated case. However, the question for the Committee to report on under term of reference three is whether or not the unacceptable under-reporting was an isolated case. In that regard the Ministry accepts that the presence of other unacceptable under-reporting over the last decade cannot be ruled out. This is consistent with Dr Gabrielle Medley’s comment on the Health Funding Authority’s National Laboratory Review, which was carried out to determine if other women were at risk. Dr Medley is a cytopathologist from Australia who was engaged by the Health Funding Authority to assist it with this review.

"I would not believe that this review could reassure you about the years 1991 to 1996 in a wholehearted manner."

6.3 Term of Reference Three requires the Committee to focus on the under-reporting which occurred and to form a view on whether or not that was the result of an isolated case or a systemic problem for the National Cervical Screening Programme. In the Committee’s view an isolated case of under-reporting is one that occurs irrespective of the wider context in which it takes place. It is something that could have occurred irrespective of the quality of the Programme. Whereas, under-reporting which represents a systemic problem for the Programme is something that occurs because the Programme has permitted it to occur. False negative smears will occur from time to time in the best of screening programmes and when they do they can be seen as isolated cases where there has been an understandable failure to read a smear test correctly. A sustained unacceptable level of under-reporting which spans a period from 1990 to 1996 and which goes unrecognised by the pathologist responsible for reading the smear tests and by the Programme is something different. That can only occur because the Programme lacked the systems and procedures to prevent it. The deficient practices followed at Gisborne Laboratories, which led to the under-reporting, carried on for as long as they did because there was no system or procedure in place either to detect them or to stop them. Those factors which the Committee has identified in its report on term of reference two as being likely to have led to the unacceptable under-reporting were the result of an environment where there was little control on how laboratories delivered their diagnostic services; even though their services were fully funded by government money. The way in which the Programme was designed and operated did nothing to prevent laboratories lacking quality control processes, from misreading smear tests. Without quality control there was a greater likelihood this would happen and without effective monitoring and evaluation of laboratory performance there was no way of detecting misreporting if it did happen. This set of circumstances could only arise if there were systemic problems with the Programme.

6.4 There is a mass of literature on what constitutes an effective cervical screening programme. This literature, which was available from the late 1980s onwards, recognises the possibility of false negative reports in screening programmes and the dangers that flow from them. The view the Committee has formed on what are the essential attributes of an effective screening programme is based on this early literature and not on later literature. The Ministry of Health submitted to the Committee that it must not allow "hindsight bias" to colour its judgement. The Committee is confident that it has not done so. It has formed its views on literature that was published between 1986 and 1993 at the latest and the reports of various advisory groups between 1990 and 1991. Further, there is nothing fundamental in the 1993 literature (the European Guidelines For Quality Assurance In Cervical Cancer Screening) that was not already stated in the World Health Bulletin on Control of Cancer of the Cervix Uteri which was published in 1986. The 1993 literature has been relied on simply as confirmation of the recommendations in the earlier literature.

6.5 In the Committee’s view, an effective screening programme is one which has in place, from an early stage, systems and procedures which are designed: to reduce the likelihood of false negative tests occurring; secondly to avoid them going unnoticed for a long time, when they do occur; and thirdly to prevent, where possible, whatever is directly responsible for the false negatives from continuing to produce them. Because the National Cervical Screening Programme did not have such systems and procedures in place throughout the time that Dr Bottrill was reading smear tests (and even after his retirement), he was able to continue with his sub-optimal practices until his retirement in March 1996. The Programme did nothing to raise concerns about the quality of his reporting. Such concerns were raised by women who, as a result of their cervical disease becoming clearly apparent, learnt that their earlier smear tests had been misread as normal. The Committee considers that this shows the Programme has systemic problems. Because some of these problems continue to this day the Committee will not confine this section of the report to the time frame in which Dr Bottrill was operating. For ease of reference it is better if current systemic problems which originate during the time Dr Bottrill was in practice are dealt with under this heading rather than under the subsequent terms of reference.

6.6 To report on this term of reference it is necessary for the Committee to form a view on when the National Cervical Screening Programme began. The Ministry of Health submitted to the Committee that the Programme did not begin until the 14 screening registers were in place. This would be January 1992. The Committee disagrees with this view. It considers that the Programme cannot be seen as having a single commencement date; its beginning is best seen as a series of developmental phases. Its genesis was a recommendation in the Cartwright Report for a national cervical screening programme. That Report was published in July 1988. After the public release of the Cartwright Report the Minister of Health announced his commitment to establishing a cervical screening programme. Between 6 and 8 December 1988 there was a national cervical screening workshop held in Porirua (the Porirua Workshop). Approximately 100 people who were broadly representative of the groups and organisations concerned with the provision of an appropriate cervical screening service participated in the workshop. Subsequently on 20 December 1988 the Minister met with his officials to discuss the recommendations of the Porirua Workshop. Decisions were made at that meeting which were intended to advance the establishment of a national cervical screening programme. Subsequently a new Minister of Health formed the view that the programme’s progress was being unduly delayed, and 25 August 1989 she sent a memorandum to the Director General of Health outlining her concern about the slow pace in setting up the Programme and requiring the appointment of a ministerial advice group to speed up progress. A ministerial advisory group (the Ministry Review Committee) was appointed and it reported to the Minister in November 1989. Its main recommendations, which were accepted, included: abandoning the planned national launch of the Programme, instead the Programme was to commence in each area health board region when the necessary programme components were in place, (this explains why it is not possible to fix a point in time for the Programme’s beginning); appointing a national co-ordinator, including a Maori co-ordinator; and appointing an expert advisory group. An expert advisory group was appointed and it had its first meeting in December 1989. The first national co-ordinator was appointed in June 1990. The first written policy for the Programme, the Government National Cervical Screening Policy 1991, was released in 1991. The 14 cervical screening registers became operational during 1991 with the last one, (the Wellington register), becoming operational in January 1992.

6.7 Thus the chronological history of the National Cervical Screening Programme can be divided into a series of phases. The first phase is from July 1988 to December 1988 when the decision to set up the Programme was made. The second is from January 1989 until December 1990 when the Programme was being designed. The third is from January 1991 to January 1992 when its implementation began, as each of the 14 cervical screening registers were set in place and began to operate in its area health board region. After January 1992 the Programme commenced operating nationally.

6.8 A Department of Health document dated October 1992 entitled Expenditure of the Cervical Screening Programme at the Area Health Board Level 1990-91 the First Establishment Year records 1990 to 1991 as being the first year of the establishment phase of the Programme. This fits with the Committee’s view. As has already been noted in this report the Government National Cervical Screening Policy of 1991 contemplated all laboratories being TELARC accredited by 1993. The Committee considers it is a reasonable assumption to make that in 1991 the Government contemplated that by 1993 the Programme would be fully operational in the sense that by 1993 all components of the Programme would be in place. By the end of 1993 approximately two years would have passed since the Programme became operational. It may have seemed to persons responsible for the Programme in 1991 that by 1993 laboratories would have had sufficient time to gain accreditation; registers would be up and running and the women who had enrolled when the registers first became operational would have been appropriately processed. The plan was that a woman would have two smear tests 12 months apart and if they were both normal she would then move to having one smear test every three years. The years between 1988 and 1989 can be seen as the design phase, the years between 1990 and 1993 can be seen as the establishment phase, and from 1993 onwards the Programme should have been fully operational.

Essential Components of a Cervical Screening Programme

6.9 Systemic problems can be avoided if a screening programme is well designed and well implemented. The essential components of an effective cervical screening programme are: a clearly expressed written policy which spells out the aims and purpose of the programme; and a clearly expressed written operational plan which spells out how the policy will be achieved. Where possible, quantitative performance standards should be specified so that the programme’s success in achieving its aims can be properly measured. It also requires an effective computerised registration programme which records cytology and histology data of women enrolled on the programme. The registration system should also either contain cancer mortality and morbidity data, or be linked to a cancer register which records such data. The registration system should be set up in such a way that it comprises a national record of the women enrolled on the programme. To the extent that any work on the registration system is done in a regional area, that work should be under the direct control of the central office responsible for the cervical screening programme. The direct control can either be through a contract based system, so that the regional work is performed by independent contractors, or persons based in a regional area who are employed by the central office. In any event, work done in any regional area has to be subject to authority and sanctions exercised by the central office; that is the only way in which national consistency of the registration system can be achieved. The data that is recorded on the registration system should be accessible by those persons working for the programme, be they employees or independent contractors. The type of data recorded and how it is used should be determined by the epidemiological benefit to be obtained from the data. In the Committee’s view the examples given in the European Guidelines for Cervical Screening Programmes are a good example of the type of data required to run a screening programme effectively. Because a screening programme is dependent on the quality of smears taken and smears read, it is essential that both the smear taking and the smear reading process is subject to quantitative standards which include sound quality control processes, both internal and external. The programme should be capable of routinely monitoring and evaluating its progress. There should not be an imbalance of attention and focus given to any one component of the programme.

6.10 Essentially, a cervical screening programme is a medical programme. Medical practitioners with specialist qualifications and experience in public health and epidemiology know what is essential for a screening programme to be successful and what can safely be left out. These persons are best able to make decisions on the design and implementation of a screening programme. Once a screening programme is established it should be managed from a central office by someone with both medical and management expertise, who has sufficient authority to ensure that what needs to be done, is done. The manager should have overall control of all parts of the Programme including sufficient authority to require actions to be taken and to impose sanctions when they are not. Without this structure confusion over responsibilities and consequent inaction will result.

Systemic Problems Of The National Cervical Screening Programme

6.11 All of the components of the National Cervical Screening Programme were not in place from an early stage. Instead the Programme began with a misplaced focus on increasing the number of women having smear tests taken at the expense of other components of the Programme. Secondly, the Programme’s design was influenced by non-medical persons who perhaps failed to recognise the essential medical requirements of a screening programme. Consequently components which needed to be in place from the outset were not, such as a registration system which enabled linkages between cytology and histology results and cervical cancer morbidity and mortality. Compromises were made in respect of their inclusion in the Programme. The end result was that the Programme was vulnerable to systemic failures. Although steps were taken later to remedy the systemic problems created by this imbalance, even today the Programme has not fully recovered from it.

6.12 The Committee has reached the view that during the time Dr Bottrill was in practice there were a number of systemic problems which the Committee considers allowed the unacceptable reporting to occur and to go undetected for as long as it did. Some of these problems have already been identified in Term of Reference Two as factors that are likely to have led to the unacceptable under-reporting. Other problems underlie those identified earlier.

6.13 The systemic problems in total are :

No compulsory quality assurance of laboratories reading cervical cytology;

A poorly designed management structure which split the responsibilities for parts of the Programme between various health agencies which resulted in confusion and fragmentation of the Programme;

No quantitative performance standards against which to measure the performance of the various parts of the Programme;

No central computerised registration system which would have allowed cytology, histology and cancer morbidity and mortality data to be inter-linked for each woman participating in the Programme ;

Failure to gather reliable relevant statistical information;

Failure to routinely monitor and evaluate all parts of the Programme’s performance;

Failure to establish strong centralised leadership with sufficient authority and qualifications to ensure what needed to be done was done;

Failure to follow the advice of various experts on the Programme.

Failure to ensure there was the legal power to do what was needed for the Programme to be effective; and failure to exercise or to exercise properly legal powers that were available to achieve this end.

6.14 The matters listed in (i) to (vi) above have all been discussed in the Committee’s report on Term of Reference Two. There is no need to elaborate further on them. The matters listed in (vii) to (ix) will be outlined below.

Failure To Provide Strong Centralised Leadership With The Appropriate Qualifications And Authority To Initiate Action

6.15 A feature of the Programme throughout the time Dr Bottrill was in practice, was the splitting of leadership functions between central (Department of Health/Ministry of Health) and regional (area health boards/regional health authorities) agencies. In addition, those leadership functions which were the responsibility of the central health agency were often further split between the agency’s various business units. The Programme’s management structure was unnecessarily complex.

6.16 From the outset there was a failure to provide for strong centralised leadership of the Programme which had the appropriate authority to ensure it could carry out the task of establishing and maintaining a cervical screening programme. This absence of strong leadership continued throughout the time that Dr Bottrill was in practice. Secondly, the Department of Health/Ministry of Health officials who were involved with the Programme lacked the appropriate qualifications and expertise to appreciate fully the implications of the Programme’s design and implementation. The national co-ordinators had a nursing background. They were not medically qualified. The Committee considers that the national co-ordinators lacked the necessary knowledge and experience to recognise the Programme’s systemic problems and the risk they carried.

6.17 In 1988 at the Porirua Workshop the Minister of Health gave an opening address in which he posed the question :

"What we need to know in essence is : what do we need to get a national screening programme up and running as soon as possible?"

Subsequently, at a meeting on 20 December 1988 Health Department officials who had considered the recommendations coming from the Porirua workshop presented the Minister with their recommendations to "get a national screening programme up and running". These included, inter alia:

The formation of an executive group with decision-making power to control the National Cervical Screening Programme and to allocate funding for the Programme to area health boards;

The creation of the role of national co-ordinator of the Programme, with the national co-ordinator being accountable to the executive group. It was envisaged that there would be two national co-ordinators, both women, and at least one of whom was Maori;

The provision of specific and separate funding for the screening Programme that was additional to that presently allocated to Vote : Health.

6.18 If these recommendations had been accepted the Programme would have started with a strong foundation. An executive group with funding control would have been in a strong position to progress the design and establishment of the screening programme. Dr Boyd told the Committee that this was one of the recommendations on which everyone at the workshop had reached a consensus, and that those who attended the workshop were persons whose opinions were valued. However, the Minister did not accept the recommendations. Instead:

He approved the appointment of a national co-ordinator; and

He decided that instead of an executive group with decision-making power he would appoint a steering group with an advisory role and with no executive functions. This group was to have a "time-limited" role with advisory and monitoring functions. The note records that the ability to go public would be its final sanction.

6.19 The Committee questioned Dr Boyd on the wisdom of appointing an advisory group instead of an executive group to develop the National Cervical Screening Programme. The Committee considered Dr Boyd to be a witness who was competent to provide expert opinion evidence as a clinician on matters of health care and its delivery in New Zealand, including the provision of cervical cytology and the National Cervical Screening Programme. He has been employed in the Ministry, and before that the Department of Health, in various roles connected with the delivery of health services since 1980. He has been a registered medical practitioner since 1964 and he is registered with the Medical Council of New Zealand in the specialities of general practice and public health medicine. Dr Boyd was asked to provide his opinion as a clinician on the appropriateness of an advisory group in preference to an executive group. His view was that an executive group of the size envisaged by the persons who made the recommendation would have been difficult; he thought that a board of management with a chief-executive would have been a better option.

"Q I note your reply that you did not think that an executive group of the size envisaged would have been workable. Can I ask you in comparison with the advisory group, would a small executive group with decision-making control and funding have been preferable to an advisory group?

A Yes, indeed. But there would also need to be one other factor again from my reading the British experience, that is a chief executive or somebody who is accountable to the board for the management and doesn’t expect an advisory group to make all the decisions and someone who also can give the programme a profile.

Q So to summarise then is it fair to say you think the ideal delivery for the programme would have been a small executive group similar to a small board of directors with a chief executive who had a largely public profile and was seen as the day to day decision-maker?

A With plenty of opportunity for input and consultation from stakeholders, affected people, and particularly the women concerned, none of that I envisaged was achieved in the Programme, but as I say it was not my decision to make.

Q Could you outline to the Committee just to clarify matters, what it was that you envisaged?

A I think as I’ve described, a person to be held accountable for the success or failure of the programme and who was answerable to a group of, I call them a board of directors, who would be chosen by the Minister for their skills and recommendations of affected groups, but also with advice and input from organisations, groups, whanau, whoever, to represent the users of the service as well as the technical people involved.

… 

Q The model that you have described - has anything resembling that model ever been put in place in respect of a New Zealand cervical screening programme?

A No it hasn’t."

6.20 The Committee agrees with Dr Boyd’s opinion. From the evidence the Committee has seen, it is clear that the Programme needed a chief-executive in whom sufficient power was vested to ensure that the Programme was established and run properly. The Programme’s management structure, from its design in 1989/1990 until 1998, with split responsibilities between a number of individuals, groups and entities resulted in a confused understanding of who was responsible for what, and it made it difficult to attribute any responsibility for inaction or failures in the Programme to any one person, group or entity. This was acknowledged by Ms Glackin in her evidence. She told the Committee: " the point I have attempted to make is it is difficult given the structure of the Ministry to assign personal responsibility to individuals for things as complex as the delivery of this Programme". Furthermore, it is hard to see how any individual, group or entity could be held responsible for defects or failures in the Programme when they lacked the power to remedy such defects or failures.

 

6.21 The design of the Programme provided for a national co-ordinator who was responsible for ensuring the effective management and co-ordination of the Programme. This was not what happened. The Programme’s services were delivered by a complex chain of different health providers. The national co-ordinator did not have the necessary power to ensure the Programme’s effective management and co-ordination. She had no authority to require action to be taken or to impose sanctions when nothing happened. All she could do was request others to carry out whatever action she thought advisable.

 

6.22 Ms Glackin described the national co-ordinator as having available to her at any given time only the powers of the particular organisation in which her position was placed. However, this is an over-statement because the national co-ordinator could not exercise that organisation’s powers. All she could do was to persuade the persons within that organisation who did have authority to exercise it. She had no power to require them to do so. Because the Programme had no control over funding, if a person or entity was failing to perform, the sanction of denying payment was unavailable. Secondly, the extent to which the organisation could act depended upon the scope of the authority it had over the failing person or entity. In its submissions to the Committee the Ministry said that when the national co-ordinator was located within the Department or Ministry of Health "she had access to the full range of powers open to the Ministry, including regulatory advice to the Minister and contracting mechanisms." The difficulty the Committee has with this submission is that the history of the Programme shows that these extensive powers were never used. The contracts the Ministry had with the regional health authorities from 1993 did not result in TELARC accreditation being made compulsory until 1996/97; prior to that the power the Department had to impose TELARC accreditation by regulations was never exercised.

 

6.23 The Ministry also submits that the national co-ordinator had to operate within the framework of the Department/Ministry’s management structure and that as a third tier manager her ability to advance issues depended upon her ability to identify them, make a case for action and influence colleagues. In the Committee’s view the Programme needs to be managed by someone who has the authority and the means available to do whatever needs to be done. The Programme should not have to depend upon a co-ordinator’s ability to plead a case for action. Secondly, this highlights the need for a medically qualified manager. Such a person would have been in a better position to outline to more senior persons in the Department or Ministry the dangers of inaction.

 

6.24 The national co-ordinator was expected to liase with advisory groups on various aspects of the Programme. Over the years these groups included: the Expert Group, the Cytology Advisory Liaison Committee, the Cervical Screening Advisory Committee and the Cervical Screening Liaison Advisory Group. None of these advisory groups had any power to require actions to be taken or not to be taken. Professor Skegg outlined the difficulties the advisory groups faced in this way.

"… The people who are on the advisory committees are actually not meeting with the people making the decisions [within the Ministry], they are advising co-ordinators who then have to lobby within the Ministry of Health for something to be done."

6.25 Apart from working with the advisory groups, she was also required to establish a close working relationship between herself and the regional Programme managers in the area health boards and the Maori regional co-ordinators. Because the area health board managers were not Department of Health employees and there were no direct lines of accountability between the area health board Programme managers and the national co-ordinator, she could do nothing to force them to act or to desist from acting in a way which was detrimental to the Programme. If her powers of persuasion failed to achieve her intentions there was little else she could do. If others chose not to listen to her she could inform the manager of the unit of the Department within which the office of national co-ordinator had been placed. However, there was little that the national co-ordinator’s unit manager could have done. For example when the Wellington Area Health Board refused to release information from its screening register, the Department was forced to prepare the Programme’s first statistical report without the Wellington data.

6.26 The Department of Health contracted with area health boards to carry out various health services. The control the Department had over area health boards was through these contracts. It seems to the Committee that any concerns the national co-ordinator had, about the performance of area health boards, could only have been authoritatively addressed through these contracts. There is no evidence that this ever occurred. Because so much of the Programme was actually delivered by persons who were not Department of Health employees, there was little, if anything, that anyone in the Department could do if these areas were failing. For example no one in the Department had the power to hire and fire employees of the area health boards.

6.27 However, the Department did have direct control over some aspects of the Programme’s delivery. For example it was responsible for paying laboratories for their diagnostic services. But, when the health system was restructured in July 1993 even this degree of control was lost. From then on the delivery of services for the Programme was through regional health authorities. Hence the restructuring exacerbated the fragmentation of the Programme’s leadership structure. Ms Glackin conceded that under the health service structure that prevailed from 1993 until 1998 the Ministry could not directly control the delivery of the National Cervical Screening Programme. This was because the regional health authorities assumed the role of funding the providers for the Programme:

"Q Just to follow on from one of your answers before, if the Ministry couldn’t influence the funding to providers is it fair to conclude that the Ministry had no way to directly control the delivery of the Cervical Screening Programme?

A That is correct."

The Ministry was left with only an indirect means of controlling the Programme’s delivery through its contracts with the regional health authorities. However, as these contracts were generic they did not provide sufficient authority to allow the Ministry to exercise any significant influence over providers for the Programme. An example is the provision the funding agreements made for TELARC accreditation during the time Dr Bottrill was practising. Ms Glackin told the Committee that the Ministry monitored the performance of regional health authorities through the formal funding agreements it had with these entities. Clearly this monitoring was based upon an examination of whether or not the regional health authorities were meeting their performance targets. Because there were few performance targets in these agreements that related to the Programme this form of monitoring was not going to detect any defects in performance .

6.28 The tasks and responsibilities of the Programme did not change under the restructured health system, but how they were delivered did change.

"Q Is it correct to say that the tasks and responsibilities of the Programme hadn’t changed, how they were being purchased and delivered changed, and the job description of the national co-ordinator had changed? Would it be fair to say the context of all these changes, they still had to be delivered and the only way to ensure that they would be delivered was for them to be contracted and agreed to by the regional health authorities?

A I believe yes that is generally so, and I think the comment was made earlier that now in fact the Programme and health funding authority is perhaps close to being delivered in the way that was envisaged in 1989 where the functions are the responsibility of one manager in the Health Funding Authority now, including the Register."

6.29 Between 1993 and 1998 the split in responsibilities between the Ministry and the regional health authorities did not work well for the Programme. There was no overall body which had the responsibility for, and the power to supervise, the running of the entire Programme. It was not until 1998 when the Programme passed to the Health Funding Authority that full responsibility and power to manage the entire Programme became vested in one entity. Even then some divided responsibilities still remained; the responsibility for evaluating the Programme remained with the Ministry. Ms Glackin accepted that the division of responsibilities was detrimental for the Programme

"Q Does that mean that at the present time the Health Funding Authority has entire responsibility and power to manage the entire Programme?

A Except for the monitoring of its contracts the Ministry’s monitoring of the Health Funding Authority and also the evaluation of the Programme, that contract has remained with the Ministry of Health. The Ministry also, as I said earlier, collects outcome data which it does at part of its health status monitoring nationally.

Q In the years between 92 and 96 clearly the management of the entire Programme was split between a number of bodies, each of whom were responsible only for components of the Programme, is that correct?

A National co-ordination and the Register were the responsibility of the Ministry, as was overall policy advice, but the actual purchase of services related to the Programme was the responsibility of regional health authorities.

Q Does that mean that overall the Programme was split between the Ministry and the regional health authorities?

A Certainly, that’s what’s dealt with in the review of accountabilities. It talks about the fact that it is considered the regional health authorities saw themselves as purchasing components of a Programme, rather than a Programme itself.

Q Do you think given your experience in the position you hold now in the Ministry that this split in responsibility had any impact on how well the Programme ran as a whole?

A In my brief I give an example of a problem with the Auckland Cervical Screening Register which I believe illustrates the issues that arose for a regional health authority when they considered that they did not have full responsibility for the Programme.

Q So can the Committee conclude from that that the split in responsibility had a detrimental impact in the overall running of the Cervical Screening Programme?

A That is the view that the Ministry put to the Associate Minister in 1996. The organisational structure meant that there was little that the Ministry could do to remedy any failures in the Programme"

6.30 After the health restructuring in 1993, all that the national co-ordinator could do was either exercise persuasive powers on the regional health authority or fall back on the powers available to the Ministry of Health under its funding agreements with regional health authorities. However, the latter course of action would only have been of assistance if the funding agreements contained specific contractual terms relating to the Programme. As the funding agreements did not, there was little that the national co-ordinator could do here, other than whenever a funding agreement was in the process of being re-negotiated, attempt to influence the Ministry of Health negotiators to include provisions relating to the Programme.

6.31 There were some lengthy periods when the Programme was without a co-ordinator. The first co-ordinator, Gillian Grew, was appointed in June 1990 and remained in the position until July 1992. When she resigned in July 1992 the position was vacant until January 1993 when Sue Dahl was appointed, and she remained in the position until September 1994. From September 1994 until June 1996, Teenah Handiside was the national co-ordinator. From June 1996 until December 1996 the position was vacant. In December 1996 Di Best was appointed national co-ordinator until April 1998 when the position was transferred to the Health Funding Authority.

6.32 Both the area health board and regional health authority systems of health service delivery compromised the Programme’s effectiveness. Ms Glackin agreed that it would have been easier to implement the Programme using a single entity with someone in a chief-executive role which had sole responsibility for developing and implementing the Programme. She also agreed that under the regional health system the result for the Programme was that there were a: "plethora of bodies involved in running the Programme".

6.33 The national co-ordinator’s lack of medical qualifications may have resulted in a failure to appreciate fully the implications of laboratories not being accredited. Ms Dahl told the Committee that when she was national co-ordinator it did not concern her that some laboratories were not accredited. She was not aware of the repercussions which could result from this:

CHAIR: Well as the national co-ordinator were you not concerned that laboratories that were just starting up, and couldn't reach the quality of standard to get TELARC accreditation straight off, were able to read cytology for the screening programme?

MS DAHL: I wasn’t concerned, no, because I had nothing to make me feel concerned. I was being assured by the committee and the people who were expert in that field that this process was occurring and I was never alerted to there being a major danger related to it.

CHAIR: Well, could this perhaps be an example of a situation where you as the employee within the Ministry didn't have sufficient knowledge yourself to realise that if laboratories were being run without any accreditation and without any standards being imposed upon them for the reading of smear tests for the screening programme that there was a greater likelihood of under-reporting than if those laboratories were having to perform according to specified standards and they were accredited laboratories?

MS DAHL: My understanding was that laboratories did have processes – QA processes; they did have accreditation processes in place. They had peer review processes. They were working in a professional manner. I visited a variety of laboratories, at the time I was the national co-ordinator, and I spoke to a variety of pathologists and people who were reading smears. I also had a close working relationship with Dr Teague and the committee, and it may have been that I did have a lack of technical knowledge in terms of the absolute specifics of what should be occurring in a laboratory, but I was not advised in any way of the repercussions that could have occurred in terms of why we’re here now.

CHAIR: But that’s the point. A medical person might well have realised the repercussions, they may not have needed to be advised of what the repercussions would be.

MS DAHL: With hindsight that may have been the case, however I was working with a group of 6 to 8 professional people on that committee, and it was their role to advise me on issues relating to laboratories, and I felt confident that I had that expert advice at my fingertips when required.

CHAIR: Did you ever contemplate doing an audit of all laboratories for the purposes of finding out whether they were TELARC accredited, whether they ran quality assurance programmes, internal or external; whether they had peer review in place?

MS DAHL: No, I didn’t.

Other evidence from Ms Dahl also confirmed for the Committee that a non medical person in the role of national co-ordinator may not realise when to press for action:

"Q: You seem to be saying that CALC wasn’t concerned about it, but at what point in time would you, as the Ministry official, consider saying, "well, whatever they say, this has been going on for too long, something has to be done about this", and so go off and speak to someone within the Ministry about getting it done?

MS DAHL: Well, that’s a good question, ma'am. CALC was my main adviser. I did not take it further, other than trying to get it in the funding agreement.

Q:: Did you not become, yourself, frustrated at times with the way – looking at it from your perspective where you say CALC kept saying all the time, "it’s going to happen, it’s going to happen" but it hadn't completely happened, did you ever get frustrated by that and think "what can be done to make it happen"?

MS DAHL: I don’t recall becoming frustrated specifically with that. I felt that progress was being made and that we had put into place meetings and whatever to make that happen. Meanwhile, I was also had other workload, there were other priorities at the time which appeared to be equally pressing.

Q:: Had anyone brought home to you at the time, or was there any appreciation at the time of how dependent on quality performance from laboratories the programme was, in the sense that if there was under-reporting it would let the programme down?

MS DAHL: There were discussions about under-reporting. At the time we were also looking to get histology results onto the Register, and that was a major priority in terms of what that would enable us to do in terms of quality checking.

6.34 In the Committee’s view a medically qualified manager would have realised, long before 1996, that something needed to be done to introduce compulsory accreditation. Furthermore, a medically qualified person with sufficient authority to ensure accreditation was compulsory would have made sure it happened. The need for good operational management with a "public health perspective" was recognised in the Cervical Screening Advisory Committee’s Report of 1994: Monitoring And Evaluation Of The National Cervical Screening Programme: The First Three Establishment Years. Although this is described as a monitoring and evaluation report it does not present an evaluation of the Programme’s effectiveness. It instead analyses what has actually occurred within the Programme since its beginning. This report stated that the lack of appropriate staff with appropriate expertise in the fields of public health and epidemiology was a barrier to monitoring and evaluation of the Programme. The report recommended the use of salaried appointments rather than advisory groups to carry out tasks of monitoring, compiling performance measures and identifying concerns about the Programme when they arose.

6.35 Another example of the need for a medically qualified manager is in relation to the original design of the screening register. The Straton Report was critical of the paucity of medical input into its design. This meant that, in the beginning, there was a failure to recognise the importance of the register as a database and an epidemiological tool. Dr Straton also considered that there needed to be one person who had sole responsibility for the screening register; she envisaged this role being separate from that of the national co-ordinator:

"It is clear that the implementation of the cervical screening register nation wide is an enormously complex task requiring liaison and consultation with many different groups and the making of many key decisions with respect to the functioning of the area health board registers. Some of the problems with the register seemed to relate to the fact that too much responsibility has rested on the computer consultants, especially recently, and there has not been enough consistent input to decision making from a person with knowledge of the realities of medical practice, as well as the functional requirements of the system. The loss of expertise associated with the turnover of experienced health professional staff in the Department of Health has exacerbated the situation, but I believe that the register has mainly suffered through not having a single person responsible for it."

6.36 One result of the lack of leadership was the undue emphasis placed upon consultation, facilitation and consensus. Government agencies have legal obligations to consult. However, these obligations require the agency to provide persons who are affected by any proposal with the opportunity to comment on it before it is implemented. The agency must keep an open mind and be prepared to modify its proposal as a result of the consultation but ultimately the power of decision remains with the agency. Consultation does not require a negotiated result to be achieved. The consultation relating to the Programme was long and protracted. The Committee was advised that this was due to the ownership of the Programme, which women and women’s groups felt that they had.

MS JANES: We've seen that consultation seems to take anywhere from 2 years on. Is there any way that some of these things can be consulted on more rapidly for the advantage of the programme?

MS DAHL: I’d like to make a comment about consultation in that consultation was considered exceedingly important with this programme. The women who had been involved, or a lot of women’s groups had a lot of ownership over the Cervical Screening Programme and it was considered to be really important that they were fully consulted. Therefore I believe the consultation process probably took longer than they would now on other policy issues.

MS GLACKIN: Could I just comment on that as well. I think this is illustrated by the fact that in 1996, when the Ministry completed what from our perspective was a relatively straight forward review of accountabilities with the intention to consult on the implementation of that review, there was a great deal of concern and in fact that resulted in Katherine O’Regan expressing very clearly her wishes that there be extensive consultation on that issue. And I think that in dealing with the Cervical Screening Programme the Ministry has always been very conscious of the degree of interest and the degree of ownership which women feel for the programme, presumably, today. Although I can't comment on that directly.

CHAIR: Do you think that concern and this need for women ownership of the programme and the high expectations upon you to consult so much with so many diverse groups has actually hindered the effective development and delivery of the programme because it’s resulted in such long delays and consultation?

MS GREW: I think it’s an advantage and a disadvantage. The disadvantage obviously is the time factor involved in consultation. The advantage is that if you do consult with population groups you tend to get better buy-in to changes or ways of co-operating with changes.

6.37 The recognition of women and women’s groups is laudable. However, it must not be forgotten that a screening programme is a medical programme. If its medical requisites are tinkered with for non-medical reasons a screening programme will not function effectively. For example opt-on registers were originally chosen to give women the power to choose whether or not they enrolled on the Registers. While this approach gave women the opportunity to exercise their power of choice actively, it rendered the Register ineffective for the purpose of providing a database for monitoring the Programme. Opt-off registers do not empower women as directly as opt-on registers do. But they are more effective because most women do not exercise their choice to opt-off, and so there are now sufficient numbers on the Register to make it a useful data base. Professor Skegg warned of this problem in his article How Not To Organise A Cervical Screening Programme, however his concerns were not heeded. Ultimately something which was done to benefit women was actually detrimental to them. Those who elected to enrol on the opt-on Registers were participating in a handicapped Programme that could not yield data suitable for evaluation:

MS GLACKIN: I would, but I should make the comment that from a technical perspective there are issues with having, apparently, sufficient numbers of women enrolled and to make the evaluation feasible. One of the issues with this programme is that until after opt-off in 1993 we had quite small numbers. So I understand there were some technical issues about when the evaluation could be done.

6.38 The Committee has seen from a Ministry memorandum of April 1996 that one of the features of the National Cervical Screening Programme is consumer ownership. The memorandum states :

"The current structure and configuration of the Programme cannot be separate from its origins, in the context of the inquiry into cervical cancer treatment at National Women’s Hospital. The Programme was seen as an attempt to redress some of the harm done by those events. It has attracted, and continues to attract, close scrutiny from the women’s lobby groups. The philosophy of the Programme has always focussed strongly on the rights of women and protection of their interests."

6.39 The Committee freely supports the sentiments set out in this paragraph, however the medical character of a screening programme must not be overlooked. To do so is to risk the effectiveness of a screening programme. For this reason the Committee is sure that most women would be more concerned to ensure that the National Cervical Screening Programme worked effectively and materially helped to reduce the incidence of cervical cancer in New Zealand than they would be with exercising rights of ownership of the Programme. Certainly the evidence the Committee has heard from the various consumer groups which appeared before it is consistent with this view.

6.40 The Committee has concluded that from the time of the Programme’s design, through to its implementation and its operation up to 1998 it has lacked strong leadership. Furthermore this lack of leadership has prevented it from recognising and remedying the systemic problems which the Committee considers were factors that are likely to have contributed to the unacceptable under-reporting at Gisborne. Everyone associated with this Programme has known of the importance of quality assurance and TELARC accreditation; monitoring and evaluation of the Programme; and having measurable performance standards and reliable data. These are the essential features of an effective screening register and yet during the years that Dr Bottrill was practising no one was able to ensure that these important components were in place from an early stage. Instead the Programme began with a sub-optimal registration system which had to be reconfigured; it has never been comprehensively monitored and evaluated; it took until late 1996/early 1997 before TELARC accreditation became compulsory even though that had been envisaged as being in place from 1993; there are still problems with gaining access to reliable data and it is only since the Programme shifted to the Health Funding Authority in 1998 that steps have been taken to implement measurable performance standards. The Committee considers that had the Programme been subject to strong leadership which had the necessary authority to ensure the Programme was well designed and well implemented and which could initiate remedial action quickly when it was needed, those systemic problems which have been identified as factors that are likely to have led to under-reporting would either have not occurred, or if they did, they would have been cured much earlier on in the Programme.

Failure to Follow the Advice of Various Experts on the Programme

6.41 There appears to have been a consistent failure to follow the advice of experts. This was in relation to how the Programme was established and certain essential features such as monitoring and evaluation and laboratory accreditation. This indicates a systemic deficiency in the Programme.

Failure To Accept Expert Advice On The Need For Monitoring And Evaluation

6.42 Ms Glackin accepted that from 1990 onwards there was very clear advice on the importance of evaluation for the Programme.

"Q I want to go back to Stratton please … on page 62 and 63 she included a section on evaluation, monitoring and research and said that a major deficiency so far has been the failure to incorporate any formal evaluation into any of the pilot projects or any other aspects of the Programme. Evaluation of the pilot community projects is now being planned, but the evaluation should be planned right from the outset. So again, there was very clear advice from at least 1990 onwards of the importance of evaluation wasn’t there?

A Yes, although the specific reference is to the need to start to collect data.

Q Yes, but in the general context of the importance of evaluations.

A Yes. That is true."

Also, the expert group in its report in 1990 had emphasised the importance of evaluation :

"Q This is an important section on evaluation and monitoring and in 14.1.2 they stress that no single indicator, except perhaps a mortality rate, exists to measure good performance. Total picture can only be developed by monitoring all aspects of the Programme and under 14.2.4 where they talked about aspects of the Programme requiring evaluation next page fourth point quality of smear reading, it was clearly identified as a matter for evaluation wasn’t it?

A Yes."

Ms Glackin was then taken through reports from the Cervical Screening Advisory Committee 1990 and 1991 which also emphasised the importance of evaluation for the Programme.

"Q So there was a very clear emphasis wasn’t there from Cervical Screening Advisory Committee from the beginning on comprehensive evaluation?

A Yes, that is correct."

6.43 In addition in 1990 the Straton Report had emphasised the need to ensure the appropriate epidemiological information was available to allow monitoring and evaluation to be undertaken. Dr Straton recommended that a small working party should be established, including an epidemiologist and a biostatistician, to define the data required for monitoring the Programme and to determine ways of extracting such data from the database. She noted that epidemiological information for monitoring was not routinely available, and that there was no provision in the specifications of the Registers for the generation of tables. She said that this question had apparently not been considered; partly because the need for these types of reports had not been considered and partly because of failure to obtain agreement about what information was needed. She described a major deficiency of the Programme when she saw it in 1990 as being a failure to incorporate any formal evaluation into any of the pilot projects or any other aspects of the Programme. She said evaluation of pilot community projects was being planned, but the evaluation should be planned right from the outset so that the appropriate data can be gathered. In the absence of any guidelines about the data required, those establishing the pilot projects did not know what was needed. She noted that the absence of any formal evaluation of the pilot projects had limited to some extent what could be learnt from them. She noted that careful thought needed to be given to the data required for monitoring, and how to extract it from the register on a routine basis. She said that as well as ongoing monitoring of the Programme through data on the register, there was a need for evaluation studies which were formative in nature, and aimed at improving the various aspects of the national programme. She recommended that steps be taken to incorporate an evaluation component into the planning of future cervical screening projects, including the delivery of services and the establishment of the cervical screening register and further area health boards with funds being specifically earmarked for evaluation. She said ideally such evaluation should be co-ordinated nationally.

6.44 The advice and recommendations made in the Cervical Screening Advisory Committee’s Report of 1994 titled Monitoring And Evaluation Of The National Cervical Screening Programme: The First Three Establishment Years identified the need for strong leadership, the need for a separate operational unit for the Programme within the Ministry (which by that time had primarily a policy-making role), the need for routine monitoring and evaluation including annual statistical reports and regular feedback to smear takers and laboratories regarding quality of performance.

6.45 Nevertheless, no comprehensive monitoring and evaluation exercise has been carried out. Nor did the Programme, during the time that Dr Bottrill was in practice, have any of the tools needed for monitoring and evaluation in place. This continued up until 2000. At that time the Health Funding Authority which had gained responsibility for the Programme in 1998 began to put in place the essential requisites to allow effective monitoring and evaluation to occur. Before then any monitoring and evaluation exercises which did occur related to other aspects of the Programme such as numbers of women enrolled. Laboratory performance in reading cervical cytology was never monitored or evaluated. Annual statistical reports were never produced and throughout the time Dr Bottrill was in practice laboratories did not receive from the Programme feedback on the quality of their smear reading.

The Committee was told by Dr Cox that he resigned from the Cervical Screening Advisory Committee because the failure to follow advice made him feel professionally unsafe:

"Q Dr Cox has said that he ultimately resigned from CSAC because he considered that he was professionally unsafe because CSAC had made, in his view, a number of recommendations; it was responsible for advising on the monitoring and evaluation of the programme. He had got to the point where he was concerned that a circumstance such as has happened in Gisborne would occur, and he considered himself professionally unsafe. Do you have any comment on that?

 

MS DAHL: I will make a comment on that. At the time that I was working with the CSAC committee we worked very hard to actually establish some specific evaluation criteria. We reviewed what had been done to date, what hadn't been done, where the gaps were, and looked forward in terms of what should happen next. At the period that I was there I don’t think that Dr Cox had expressed those views. He may have been frustrated by some of the departmental type processes that had to be gone through, but I never heard him express anything as explicit as that."

The Ministry’s counsel did not cross-examine Dr Cox on this issue and so the Committee is unaware of what his response would have been to Ms Dahl’s evidence on this point. That is unfortunate, as cross-examination is the best means of resolving disputed evidence. Even so, the impression the Committee gained of Dr Cox, when he gave evidence, was that he was a truthful witness. Whether or not he expressed his feelings to the Ministry officials at the time he resigned does not mean he did not have such feelings. The Committee accepts his evidence.

6.46 Ms Dahl was then referred to a Health Funding Authority memorandum of 1999 headed Public Health Operation Group – Non-discretionary Project. The name of the project was National Cervical Screening Programme and the project’s classification was, "inability to perform core business". The memorandum noted that since the Programme was established there had been "no national quality standards developed, little monitoring or evaluation carried out and no strategic review of programme configuration or direction". It also noted that the Programme did not have adequate procedures and structures in place to ensure the safety of women. It drew on the potential under-reporting in Gisborne to support this view. The memorandum stated that "the ability of the situation to develop to the extent that it had can be largely attributed to the lack of quality systems and monitoring of the Programme." The memorandum went on to acknowledge: that there had been ongoing calls for monitoring and evaluation of the Programme "since its inception in 1991 by various groups including the Cervical Screening Liaison Advisory Group, programme providers and women’s health groups; secondly that the Programme was never set up with any ongoing monitoring or evaluation in place, and as such no budget was transferred to the Health Funding Authority from the Ministry of Health for this purpose". The memo then referred to the independent evaluation being carried out by the Otago team and referred to correspondence between the Chief Executive of the Health Funding Authority and the Ministry of Health in which the Health Funding Authority had written that it was primarily concerned in establishing ongoing quality mechanisms for the National Cervical Screening Programme. Ms Dahl’s comment on the memorandum was that it seemed harsh:

"MS DAHL: I think it’s a very harsh interpretation, the way it’s put I believe it’s very harsh. I believe that every endeavour was made in the period that I was there to actually assess what had been done. There had been process evaluations, small evaluations done. There’d been small monitoring reports, there’d been statistical reports, there'd been sort of a lot of ad-hockery, and so the focus when I was there was to try and move from that into some systematic way of actually monitoring and evaluating the programme. My expectation would have been that that would have occurred."

6.47 This memorandum initiated the development of detailed policy and operational documents for the Programme by the Health Funding Authority including quantitative performance indicators and other mechanisms to ensure good quality control. The memorandum outlined the risks of not carrying out this project. One of the risks in not ensuring good quality control through monitoring and evaluation was said to be the likelihood that further women will develop invasive cervical cancer because of a lack of quality standards and monitoring in place, with the attendant organisational costs of investigating and managing each of these incidents. The memorandum gives a good indication of the views of the Health Funding Authority at that time and the concerns it had over the Programme’s operation. It shows how that entity understood and applied expert advice on screening programmes, and its view on the operation of the New Zealand Cervical Screening Programme. The memorandum confirms for the Committee that the earlier advice of experts on the need for monitoring and evaluation of the Programme’s performance was correct and ought to have been heeded.

Failure To Accept Expert Advice On The Need For Laboratory Accreditation

6.48 The evidence the Committee heard from Dr Teague, who was a member of the Cytology Liaison Advisory Committee, was that this committee had regularly advised the Department and the Ministry of Health on the need for laboratories to be TELARC accredited. His evidence was that this committee had confidently expected TELARC accreditation to be compulsory by 1993 and that accreditation could be enforced by withholding payment from unaccredited laboratories. Ms Dahl accepted that when she was national co-ordinator the Cytology Liaison Advisory Committee had advised her that laboratories should be working towards TELARC accreditation and that this was occurring.

6.49 From the evidence which the Committee has seen it is clear that in the early stages of the Programme the advice from the various other experts (Dr Straton, Ministerial Review Committee and Experts Group) was that laboratories should be accredited with an independent quality control authority. Up to 1996 the advice was not followed in the sense that the Department and subsequently the Ministry failed to put in place a fail-safe mechanism which required laboratories to be accredited. After 1996 the Ministry did include in the Policy document a requirement that laboratories be accredited and regional health authorities then began the process of including this requirement in their agreements with the laboratories.

Failure To Follow Expert Advice On The Need To Have All Parts Of A Screening Programme In Place From The Outset

6.50 The Programme’s design appears to have been influenced by lay persons, who seem not to have recognised that a screening programme has certain essential requirements, and that their absence will jeopardise the programme’s effectiveness. The expert advice at the time the Programme was being established was that all parts of a screening programme needed to be in place from the outset. This advice was not followed. During the Programme’s design phase there was a misplaced focus on increasing the number of women having smear tests taken; this was at the expense of other parts of the Programme. This misplaced focus created an imbalance between smear taking and other essential parts of the Programme.

6.51 The emphasis on smear taking appears to have resulted from a political concern that the Programme’s establishment was not occurring in a timely fashion. This political concern caused the Minister of Health, on 25 August 1989, to send a memorandum to the Director General of Health outlining her concern about the slow pace at which the Programme was being set up. Unfortunately, the memorandum had two detrimental results : it imposed time pressures on officials which resulted in unrealistic deadlines; and secondly it caused a shift in focus away from a balanced screening programme to one which placed an emphasis on increasing the number of women having smear tests taken. This shift in emphasis was at the expense of other parts of the Programme.

6.52 The memorandum said :

"In my view the current state of misinformation and concern among those groups who have an interest in the success of this Programme clearly shows that the Department has not been successful in developing a Programme which has the support of the community and can feasibly be put into operation by the end of the year.

There is widespread concern that there has been too much emphasis placed on the development of the national register and the computing system necessary to operate a register and recall system, at the expense of action on developing smear-taking programmes. I share this concern.

My objective is to use the money made available by Government to raise the awareness of the necessity for smears among those women not currently being screened, and to encourage all women to have regular smears. The importance of the register and ensuring all women are enrolled should probably be secondary to that."(emphasis added)

The memorandum continued by stating that the Minister wanted a ministerial review team set up to look at the progress of the Programme to date, and to recommend the appropriate course of action and appropriate allocation of available funds:

"It should not be assumed that the funding split between computing, administration costs and smear benefits is in any sense fixed. I believe it is likely that we should be spending more of the money in paying for smears and ensuring that those groups not currently being smeared are provided with easy access to smear takers." (Emphasis added)

She concluded her memorandum by stating :

"I am not committed to launching a national register by the end of this year. I am committed to ensuring that the proportion of women having smears increases over the year and that we make steady progress towards a co-ordinated national cervical screening programme."(emphasis added)

6.53 The Minister’s concern to increase the momentum of establishing the Programme is understandable. The lack of strong leadership was having a detrimental effect on the Programme’s establishment. One of the reasons given for the delays was poor communication. This is understandable given the absence of a chief-executive with the necessary authority to advance the Programme’s establishment. After the Cartwright Report there would have been immense public pressure to establish a cervical screening programme. The requisites for a screening programme to be fully effective are not easily communicated to lay persons and so there may have been difficulties in communicating this information to the public. The Committee may not have heard all the evidence it would have liked to receive on this point. The passage of time has meant that the Committee has had to rely upon whatever documentary evidence can still be located and on witnesses’ memories. The Committee can understand that a Minister faced with this predicament would respond by putting pressure on officials to have something in place within an early time frame. However, the decision to place the emphasis on increasing the number of women having smears taken and the continued use of advisory groups was not ultimately helpful.

6.54 There is little authoritative material to support giving priority to increasing the number of women having smears taken at the expense of other components of the Programme. The only support the Committee is aware of comes from the Azimuth Report which stated that smear taking is the key factor affecting the success of a screening programme:

"It must be recognised that smear taking is the key factor affecting the success of a screening programme. The delivery of the screening service must meet the needs of New Zealand women."

It also stated:

"This investigation has shown that while there are medical issues involved in the establishment of a cervical screening programme it is primarily a management and administration problem and should be tackled as such. The perception is that medical details have dominated to date and contributed to the slow progress."

The Azimuth Report was written by a firm of computer consultants who were hired to develop the computerised screening register. Apart from this report there is no other material before the Committee which supports placing an emphasis on smear taking and to treat other aspects of the Programme, such as a screening register and enrolment of women, as secondary. Perhaps these comments caused the Department officials to begin to doubt the advice being given from medical experts. There is no direct evidence one way or the other. However, the issue is important because unless the lessons to be learned from the failure to accept expert advice are understood, similar mistakes can still be made.

6.55 The Committee considers that there was no point in encouraging women to have smear tests taken when their smear tests were being read at laboratories whose performance was accepted on trust and which may have been performing inadequately. This imbalance was subsequently recognised by Dr Straton in her report.

" High quality laboratory services are a vital link in the establishment of an effective screening programme, yet this aspect of the programme seems to have received much less attention in New Zealand than the recruitment of women to be screened. There is no point in putting a great deal of effort in encouraging women to be screened if the quality of the screening service is inadequate and there are long delays in receiving results." (emphasis added)

6.56 The Straton Report, which was prepared in 1990 noted that there were aspects of laboratory services which needed attention. These included accreditation, quality control, training of cytoscreeners, coding of results and the interface between the laboratories and the registers. She said there was a concern that there had been insufficient consultation and inadequate assessment of the resources needed to provide proper screening services at laboratory level.

6.57 The Ministerial Review Committee (1989) recognised the need to have all parts of the Programme in place. One of its major conclusions was that :

"Attention should not be focused on any particular aspect of the Programme. For a cervical screening programme to be successful all aspects must be developed simultaneously as each is an integral part of achieving success."

Nevertheless, the Programme’s design and development from November 1989 onwards is not consistent with that recommendation being adopted. The Ministerial Review Committee had recognised the importance of correlating histology with cytology on the register and had urged that it be given immediate attention. However, the software for the 14 stand-alone registers did not allow for this. Nothing was done to ensure laboratory performance was adequate and nothing was done to ensure that monitoring and evaluation could take place.

6.58 The Ministerial Review Committee referred to such things as minimum numbers of smears to be read at laboratories, correlation of histology with cytology, training of cytologists, it recommended that a set of minimum standards of competency for laboratories and smear readers should be developed, and that performance indicators that would enable compliance with these guidelines to be assessed, should also be defined. It even suggested performance indicators in its report. However, none of these components of the Programme were in place when it began.

6.59 The decision to use opt-on registers was not supported by expert advice. In its submission to the Committee the Ministry describes the use of opt-on registers as occurring almost by default. The submission states;

" The opt-on register decision had not been made at this stage [ approximately 1988] Rather a refusal to promote the necessary legislation for an opt-off Register was (sic) by the Minister after the Ministerial Review Committee and the Expert Group had reported in 1990.

In responding to criticism from other parties in the inquiry regarding the use of 14 stand-alone registers and the original decision to exclude histology from the register the submission says that the source of these decisions cannot now be traced:

"The decisions to exclude histology from the initial register and to set up 14 separate registers were givens at an early stage. It is not known whether these decisions were made at the departmental or ministerial level, but we do know the very tight timeframes imposed by respective Ministers to the Programme."

6.60 The Ministry in its submission emphasised the tight timeframes which were placed on establishing aspects of the Programme. It refers to Ms Sandra Coney’s evidence that the Ministerial Review Committee were convinced by the Department that significantly delaying the start of the Programme was not acceptable. The Ministry in its submission says that this was the view of the Minister, and that while she was not committed to launching the Programme on 30 November 1989 as originally planned she wanted to be able to show continued progress.

6.61 The Ministry rejects the submissions of other parties to the Inquiry that the Government implemented the Programme with undue haste, and against the advice of the expert group. The Ministry submits that both the Ministerial Review Committee and the expert group recommend that the Programme not be delayed until Register issues were resolved and the evaluation of pilot programmes completed.

6.62 The Committee has read both the reports of the Ministerial Review Committee and the expert group. Its impression of these reports is that in principle both advisory groups considered that it was important to have all the components of a screening programme in place from the beginning. Their reports reveal an awareness of strong pressure to advance the Programme’s establishment. Their willingness to go along with the Programme being established in a piecemeal fashion seems to the Committee to be more shaped by a pragmatic realisation of what was going to be achievable, rather than by what they considered to be the best approach.

6.63 The manner in which the Programme was established may have worked if the initial components which were in place had been appropriate, and if the foundation of existing health services on which the Programme was to be built were sound and had been thoroughly checked out. The overseas literature recommends that when a programme is going to be built upon existing services they should first be fully evaluated. A programme that is built upon existing services will be inherently flawed if the services themselves have flaws.

6.64 In respect of the New Zealand Cervical Screening Programme there were two problems which made its piecemeal establishment more detrimental to the Programme than it might otherwise have been. The first was that the components that were initially put in place were not appropriate. A system of 14 stand-alone opt-on registers was unworkable. The Programme could never be an effective cervical screening programme while set up in this way. Secondly, the existing health services upon which the Programme was based were not evaluated, and therefore the quality of their performance was unknown. An important component of the existing services was laboratories. They were not subject to any quality control or accreditation processes and their work performance had never been assessed. Therefore, when the Programme was established using existing services, nothing was known about the performance quality of the laboratories. Ideally, if existing services are going to be used, they should be thoroughly evaluated, and any deficiencies in them corrected before the Programme begins. The Department of Health did send a team of persons around to look at laboratories and evaluations were carried out of the various pilot cervical screening programmes which were tried in various regions, however, none of these evaluation studies were designed to detect poorly performing laboratories. There was never any critical evaluation of the quality of laboratory performance before the Programme began.

6.65 The need for a full evaluation of the existing services that will be used in a new screening programme, which critically assesses the quality of their performance is clearly stated in the authoritative literature the Committee has read on establishing cervical screening programmes. The outcome for the National Cervical Screening Programme was that its piecemeal establishment was built on a shaky foundation, and some of its initial components ultimately had to be replaced. This meant that those persons charged with the responsibility for implementing the Programme were faced with a task whereby they had to work towards developing the later stages of the Programme, while at the same time having to redo the first stage work.

6.66 Thus by 1993 it had become clear to the Department of Health that the Programme which was in place needed to be redesigned. The screening registers needed to change from opt-on to opt-off and the fourteen stand-alone registers in the area health board regions needed to be combined into a single national database which allowed histology to be correlated with cytology. In the Committee’s view there is no reason why these things could not have been put in place from the outset. The expert advice did not support the Programme’s original design.

6.67 It seems to the Committee that anxiety in 1989 to ensure that the Programme proceeded at a reasonable pace, her concern that smear taking be encouraged in priority to other aspects of the Programme and the decision to deliver the Programme using area health boards to establish, operate and monitor 14 stand-alone registers, created systemic problems in the Programme which needed correction if the Programme was to perform properly. The response to the perceived delay in establishing the Programme, while intended to facilitate its establishment, only created other problems for the Programme because it resulted in an imbalance of its parts. Until this imbalance was corrected the Programme was never going to function properly. For example, until quality assurance of laboratories was in place and effective monitoring and evaluation carried out, the Programme was never going to be able to identify if smear tests were being adequately read.

6.68 There was a failure to recognise the value of the screening registers as a means of managing the Programme. The Ministerial Review Committee had said in its report that it acknowledged the register was being developed primarily as a system to facilitate cervical screening and recall. In the Committee’s view, a cervical screening register as part of a cervical screening programme should be more than this. It should also be able to provide information which would be of assistance in managing the Programme. While the information the system provided was helpful in terms of smear taking, it was not able to provide sufficient information in respect of smear reading to be of any use until it was reconfigured and histology was added to it. This was not completed until 1997.

6.69 The Ministry has contrasted the establishment of the cervical screening programme with the establishment of the breast screening programme. Both these programmes were piloted at the same time, but the Ministry says :

"With the Cervical Screening Programme being imposed largely on existing screening services and under intense public and political pressure. The National Breast Screening Programme, by contrast, was not launched until December 1988 after standards and procedures had been worked out."

6.70 The Ministry appears to suggest that had the same approach been taken to the National Cervical Screening Programme as was taken to the Breast Screening Programme, they both may not have been launched until December 1998. The difficulty with this submission is that the Committee did not hear full evidence on the establishment of the Breast Screening Programme, and it therefore has no idea why it took until 1998 to launch a breast screening programme that was first piloted in 1989. It, therefore, cannot make an appropriate comparison with the two programmes. Secondly, there was no evidence as to how long it would have taken to have the National Cervical Screening Programme in place, if its launch had been delayed until all its components were present.

6.71 Furthermore, if the Programme had not been in place during the time Dr Bottrill was in practice, women in Gisborne would not have relied upon it, and therefore they may have been more alert to protecting themselves from developing cervical cancer. It cannot be assumed that without a programme women simply would not have had cervical smear tests. They may have resorted to opportunistic screening and had more cervical screening tests than they did under the Programme. Because the Programme was not fully effective, women were unknowingly relying upon a defective programme to protect them from developing cervical cancer. Thus it cannot be argued that, without the Programme, women would have been in the same position or worse off. At the very least they would not have had the false sense of comfort.

6.72 In addition, one of the reasons why some members of the medical profession appear to have been initially reluctant to accept there was a significant under-reporting problem in Gisborne which required investigation, was because laboratories can make false negative reports and the women who were participants in a screening programme had a history of normal smears. The presence of the Programme also appears to have given the women’s medical practitioners a false sense of comfort. From the files the Committee read there were women with signs of cervical cancer who were initially assured by their clinicians that they could not have cancer because they had a history of normal smear tests. Were they not participating in a screening programme, their clinicians may well have considered the possibility of cervical cancer more readily. The thrust of the Ministry’s submission seems to be that it was better that the Programme be in place in its defective form than not at all. The Committee’s view is that this is not an answer to the deficiencies of the Programme. The Committee heard from witnesses that a defective programme can create a false sense of assurance. It may well have been better to have nothing, and therefore no assurance at all, than the false comfort that the Programme provided. This is the impression the Committee gained from Professor Skegg’s submission. He is an experienced epidemiologist with a world renown reputation. He submitted to the Committee that it may be better to abandon screening programmes if adequate steps are not going to be taken to monitor the quality of the process or of the outcomes achieved:

"Unfortunately the problems I have described [ in gaining access to essential information and inability to audit ] are not isolated or unusual incidents. Unless such problems can be resolved, it could be argued that New Zealand should consider abandoning national programmes such as those for the control of cervical cancer and breast cancer. It seems unethical to exhort apparently healthy people to undergo medical procedures, when adequate steps cannot be taken to monitor the quality of the process or the outcomes achieved.

This submission suggests to the Committee that Professor Skegg does not favour the view that an inadequate screening programme is better than nothing at all. While it can be said that the Programme has reduced cervical cancer morbidity and mortality in New Zealand, that is on a national basis. The Programme did little to assist the women in the Gisborne region. It can be little comfort to them to know that nationally there has been a reduction in cases of cervical cancer.

6.73 The Programme got off to a bad start. By the time the need for change was recognised there were already women enrolled on the Programme, and so the Department of Health and subsequently the Ministry of Health was faced with the prospect of having to redesign a programme which was already in operation. This meant that instead of being able to focus on getting the design and implementation right, energy was divided between running the Programme in its sub-optimal state and having to deal with the problems thus created, while at the same time trying to introduce the necessary changes to the Programme. The impact on the Programme of the failure to have everything essential in place from the outset is exemplified by the interchange between counsel assisting, the Committee and Ms Glackin:

MS JANES: The evidence of certainly Dr Cox was that this clinical audit or retrospective look at women who developed invasive cancer should, as Ms Glackin has said, be a routine occurrence. Would you accept that if that had occurred early on in the programme the problems with s74A would have been understood much more quickly than it has been now?

MS GLACKIN: I would, but I should make the comment that from a technical perspective there are issues with having, apparently, sufficient numbers of women enrolled and to make the evaluation feasible. One of the issues with this programme is that until after opt-off in 1993 we had quite small numbers. So I understand there were some technical issues about when the evaluation could be done.

CHAIR: But I understand Ms Glackin that in terms of the clinical audit of cases, … if in an area you are having women develop cancer and if you go back to their smear test history and you see that within a certain period of time – say 5 years – they’ve had 2 normal smear tests, if you get more than 1 case of that occurring it can be an indicator (quite a strong indicator) that there is under-reporting. So, if you had just been able to compare the two sets of data from two registers and look at the pattern of the smear histories it could have been a red flag to the need for further investigation to see if there was under-reporting in that area.

MS GLACKIN: Yes, indeed, if the data were available from the Cancer Registry, yes.

CHAIR: And do you agree this really reinforces what the World Health Organisation was saying to run a programme effectively you really need to have all aspects in place at once, or if you are building up good data from the Cancer Register and the Screening Register and you can make the necessary links and if you can make the necessary links between cytology and histology all these factors go to help you identify more readily cases where the programme might be failing in respect of under-reporting of smear tests?

MS GLACKIN: I would agree with that, and I think, looking over time, what we have been doing is progressing towards that state. I think the Inquiry is well aware of how long various aspects of that have taken. I should perhaps make the point, of course, which the Inquiry is well aware of, that the Cancer Registry deals with cancers of all sorts."

This evidence shows that the Programme, which was designed between 1989 and 1990 and fully operational from early 1992 onwards, still does not have in place all of its essential components.

Failure To Ensure That There Was Legal Power To Do What Was Needed For The Programme To Be Effective And Failure To Exercise Or To Exercise Properly Legal Powers That Were Available To Achieve This End

6.74 An effective cervical screening programme requires sufficient legal power to ensure that whatever needs to be done is done. In addition it is helpful if these powers are clearly stated as otherwise there will be confusion when it comes to exercising them. The Committee has been dismayed to learn that the National Cervical Screening Programme lacked certain necessary legal powers throughout the time that Dr Bottrill was in practice. These necessary legal powers continue to be absent. Secondly, there has been a failure to recognise the availability of existing legal powers and so these have been unexercised. Thirdly, at times existing legal powers have not been properly exercised, to the disadvantage of the Programme. The resulting legal quagmire has been a real obstacle to the Programme’s effectiveness; its presence is indicative of a systemic deficiency within the Programme. An effective screening programme would have the necessary legal power and ability to achieve its purpose and to allow it to work effectively. This is something which should have been recognised and put in place from the beginning. Similarly any structural or other changes to the Programme should have been accompanied by whatever legal adjustments were necessary to allow these changes to work effectively. Unfortunately this was not done.

6.75 Legal inadequacies have been of most concern to the Committee in relation to:

The monitoring and evaluation of the Programme

The compulsory imposition of quality assurance processes on laboratories reading cervical cytology;

No Monitoring and Evaluation

6.76 The Ministry of Health has always had responsibility under the Policy documents for monitoring and evaluating the Programme. The Policy documents of 1991, 1993 and 1996 all placed this responsibility on the Ministry. As late as 1996 the Policy stated in para 3.6.2 that it was the Ministry of Health’s responsibility to ensure that the Programme was monitored and evaluated nationally.

"3.6.2 Monitoring and Evaluation

The Ministry of Health is responsible for ensuring that the NCSP is monitored and evaluated nationally. It is responsible for ensuring that any necessary response is made to information obtained from the NCSR, performance indicators, routine or other analysis. It is the Ministry of Health’s role to make sure that progress towards achieving the goal and objectives of the NCSP is evaluated and fed back to provides and the community. To ensure this is achieved, the Ministry of Health is beginning an evaluation of the NCSP in the 1996/97 year. This will include evaluation of the NCSP’s provisions to priority groups and other sub-populations, evaluation of the NCSP’s acceptability to consumers, and evaluation of expenditure on the NCSP.

The NCSP is unique in that the NCSR, which is located in the Ministry of Health, contains much of the information for effective monitoring and evaluation.

The effectiveness of the NCSP will be judged ultimately in terms of the incidence of and rates of deaths from cervical cancer. There will be considerable lag, however, before the impact of changes in cervical screening are reflected in lowered incidence and mortality rates. Data collection and analysis of interim measures are carried out for quality assurance of service delivery, comparative assessment of providers and monitoring and evaluation of processes and outcomes along the screening pathway. To ensure cost-effectiveness of monitoring and evaluation, the amount of data collected should be the absolute minimum to adequately address the relevant issues."

And in August 1997 Ms Glackin wrote to all laboratories attaching a report of an analysis of the laboratories’ smear test results. The letter stated:

"One of the NSCP’s major principles has been the implementation and emphasis on quality assurance with the aim to reduce the number of false negative results."

6.77 The reality is that when the Ministry came to carry out many of these actions it found that there were legal barriers to doing so. Clearly these legal barriers were not foreseen by the persons responsible for writing the 1996 Policy, or by anyone else in the Ministry at that time. The first time the Ministry realised there were legal barriers to the comprehensive monitoring and evaluation exercise going ahead was in 1999 when the independent evaluation team it had engaged could not access vital information held on the National Cervical Screening Register or the Cancer Register. The independent evaluation team could not investigate whether invasive cervical cancers were detected by regular screening or by another method, as Ministry of Health staff would not allow them to access information from the Cancer Register which identified women with invasive cervical cancer. Nor would the evaluation team have been able to access information on the National Cervical Screening Register to learn the screening histories of these women, as s.74A of the Health Act denied them access to this information. Although, as stated in the Policy 1996, this Register is now a source of information which can be used for effective monitoring and evaluation, there are legal barriers which prevent it from being used in this way.

6.78 Initially the National Cervical Screening Register could not for practical reasons be used as a tool for monitoring and evaluation until it became an opt-off register which had been reconfigured into a centralised registration system, and the data on the Register had been audited to ensure its reliability. However legislation which permitted these necessary changes also introduced the legal barriers which now prevent the data on the Register from being utilised by an independent evaluation team.

6.79 In response to the Ministry’s call for an independent evaluation of the Programme in 1996 an independent team of medical experts from Otago University tendered its proposal for the evaluation in June 1997. This proposal was rejected on the grounds of cost. The Committee has learnt in evidence from Dr Cox who was part of the independent audit team, and from Dr Peters, who is currently responsible for