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Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region6. Term of Reference ThreeWhether 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?
6.30 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:
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:
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:
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.
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:
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 :
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.
Also, the expert group in its report in 1990 had emphasised the importance of evaluation :
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.
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:
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:
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 :
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:
She concluded her memorandum by stating :
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 also stated:
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.
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 :
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;
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:
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 :
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:
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:
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:
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.
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:
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 the Programme, that the evaluation as envisaged in the June 1997 tender is worthwhile and should be carried out. The Ministry then called for further tenders for a partial evaluation of the Programme. A second tender was put forward by the same independent team from Otago University, and this was accepted in 1999. This limited evaluation plan comprised three phases. Ms Glackin told the Committee that when cost had ruled out the comprehensive evaluation these three phases were chosen because the Cervical Screening Advisory Committee considered them to be the highest priority. The first phase was able to be completed without meeting any legal obstacles. However, the second and third phase foundered as a result of legal problems relating to access to essential information. 6.80 The second phase of the evaluation involved looking at the appropriateness of follow-up and treatment for women with abnormal smears. The aim of this phase was to assess whether the treatment offered to women with abnormal smears was in accordance with the guidelines for the management of abnormal smears in the Programme, and whether all women with abnormal smears were followed up; to assess the proportion of women who continued to have abnormal smears after treatment of low-grade squamous intraepithelial lesions and high-grade squamous intraepithelial lesions; to assess the timeliness of follow up for women who have abnormal smears and assess the specificity of cervical screening in New Zealand. At the time of the public hearings, the Committee was told that the second phase could not be completed. This was due to the evaluation team being unable legally to gain access to the information it needed from the National Cervical Screening Register in order to carry out this phase. The legal barrier that prevented them from doing so was s.74A of the Health Act. That section was also given as a reason for the Director-General refusing to respond to the Committee’s subpoena issued under s.4d of the Commissions of Inquiry Act. The Committee had ordered the Director-General to produce certain information about identifiable women which was held on the Register. The correctness of the Ministry’s legal interpretation of s.74A in this regard was to be referred to the High Court. However, because it became clear to the Committee that any High Court judgment on this issue would be of academic value only, owing to proposed new legislation which would remove the powers of a Commission of Inquiry in relation to ministerial committees. Thus, the reference to the High Court was abandoned. 6.81 Section 74A was intended to protect the confidentiality of women’s information on the Register. It, therefore, limits the circumstances in which data on identifiable women can be obtained. Access to data on identifiable women is so circumscribed by s.74A that persons contracted by the Ministry of Health to access the data for the purposes of evaluating the performance of the Register and the Programme, cannot legally do so. The Committee was appalled to discover that qualified medical persons engaged under contract by the Ministry of Health to evaluate the Programme could be prevented from evaluating a pivotal part of the Programme by legislation which the Ministry itself had promoted. Ms Glackin accepted that at the time of promoting this legislation the Ministry had failed to appreciate its true force. She told the Committee that the official in the Ministry of Health who was responsible for managing the evaluation had thought s.74A did not prevent the evaluation team from having access to the Register:
Moreover it was not until December 1999 that the Ministry discovered the problem s.74A created for evaluation.
6.82 The Committee first learned of the difficulty the evaluation team was encountering when it heard evidence from Professor Skegg. The Committee was keen to see if there was a way around the barrier which s.74A created. It appeared that either s.74A must be amended, or a way through the legal barrier found, or the second phase of the evaluation could not be carried out. The Committee learnt from evidence filed after the public hearings that this phase is now proceeding. It is anticipated that this part of the evaluation will be completed by 1 June 2001, however the project is about eight months behind schedule. This phase was originally included in the comprehensive evaluation plan put forward in June 1997. If all goes according to plan the first evaluation of the appropriateness of follow up and treatment of women with abnormal smears will be available by June 2001, some 10 years after the Programme’s implementation. 6.83 Section 74A does contain a power to make regulations which do permit persons to have access to data of identifiable women on the Register. However, no such regulations have been made. Secondly, the regulation-making power does not specifically cover the release of this information for evaluation purposes. The section refers to the release of information only to persons studying cancer. In its present form s.74A would only permit regulations allowing an evaluation team to access data on the Register which identifies women if the task of the evaluation team amounted to a study of cancer. On a very wide interpretation of this phrase it can be said that a screening programme is a tool to avoid cervical cancer; an evaluation is a study to see if a screening programme is effective in this capacity; or an evaluation is a particular aspect of such a study; therefore it is within the meaning of the section. But this is not satisfactory. Legislation should be more specific than this. One of the core purposes of the Register is to provide information for the purpose of monitoring and evaluating the Programme’s effectiveness. Therefore, legislation relating to the Register should clearly and unreservedly permit an evaluation team engaged by the Ministry to have access to all information of the Register. There should be no room for doubt about the legality of access to the Register. 6.84 In the Committee’s view s.74A indicates a systemic deficiency in the Programme. Whoever in the Ministry was responsible for preparing a draft of the section and instructing Parliamentary Counsel to draft the Parliamentary Bill to amend the Health Act failed to provide evaluation teams with access to the protected information. This indicates a breakdown in communication between this official in the Ministry and the officials having responsibility for the Programme. 6.85 Secondly, since no official who had responsibility for the Programme recognised the true effect of s.74A no attempt was made to use the regulation-making power allowing persons studying cancer to have access to the protected information. Regulations were made under s.74A(7) controlling access to data on Maori women enrolled on the Register but no other use was made of the regulation-making power. The Ministry officials were unable to provide the Committee with an explanation for this:
Ms Glackin accepted that subject to carrying out appropriate consultation, regulations could be made at any time. She advised the Committee (on 6 August 2000) that the Ministry was presently working on regulations to overcome the obstacle that s.74A presented to the evaluation team. 6.86 None of this would happen in a well designed and well implemented screening programme. It is essential that the necessary legal foundation for a screening programme is in place from its outset and if the Programme is subsequently altered the legal implications which flow from this should be thought through and understood before the change is made. 6.87 The third phase of the evaluation plan is an audit of the screening histories and management of women with invasive cervical cancer. The aim is to assess the results and frequency of previous cervical smears of women with invasive cervical cancer; to review the management of previous abnormal smears in women who have developed invasive cervical cancer; and to review the cytological and histological results of women who have recently been diagnosed with invasive cervical cancer. This phase is essentially the cancer audit, which is described in Term of Reference Two. 6.88 The Committee has already stated in its conclusions under Term of Reference Two that it considers a cancer audit to be the gold standard for assessing the success or failure of a screening programme. It is an effective way of detecting under-reporting. However, the most recent evidence the Committee has received on the status of the evaluation shows that this phase has still not been carried out. The reason for this is complex. To carry out this phase of the evaluation the evaluation team required access to information of identifiable women held on the Cancer Register. The Cancer Registry staff would not release the information to the evaluation team without them having Ethics Committee approval for the evaluation. The Cancer Registry acted in this way because it considered that rule 11(2)(c)(iii) of the Health Information Privacy Code 1994 governed the disclosure of information to the evaluation team. The effect of this rule is that researchers wanting access to health information must satisfy the entity holding the information that they have obtained ethical approval from an ethics committee. However, it did not apply to the request the evaluation team had made. 6.89 The law governing the release of official information is complex. Some information is specifically protected by statute. An example is the information on the National Cervical Screening Register which is protected by s.74A of the Health Act. However, usually access to official information is not covered by specific legislation like s.74A, in which case either the Privacy Act and any code made under that Act or the Official Information Act will apply. The Cancer Registry Act 1994 imposes no restrictions on access to the information held on the Cancer Register. Therefore, depending upon the circumstances either the Privacy Act or the Official Information Act will apply. When the information has been requested by the person to whom it relates the Privacy Act, and in the health sector the Health Information Privacy Code, governs the release of the information. Secondly, any voluntary release of information about a natural person by a government department is governed by the Privacy Act and in the health sector by the Health Information Privacy Code. Thus, government departments cannot, of their own volition, chose to release official information which identifies an individual. Finally when official information which identifies an individual has been requested by anyone other than the individual to whom the information relates the Official Information Act 1982 governs its release. This legislation takes precedence over the Privacy Act and any Codes made under it. The information on the Cancer Register is information held within a government department and, therefore, it is subject to the Official Information Act 1982. 6.90 There is no mystery about how the Official Information Act fits with the Privacy Act. Since both pieces of legislation have been enforced, the Privacy Commissioner has published information explaining which Act applies in given circumstances. The latest publication is the Health Information Privacy Code reprinted in June 2000. That document states that :
The Code continues :
6.91 The evaluation team were seeking information which identified women recorded on the Cancer Register as having cervical cancer and therefore their request should have been dealt with under the Official Information Act. Section 9 of this Act protects the privacy of individuals, but it also favours release of such information where the public interest outweighs protecting an individual’s privacy. In view of the importance of a cancer audit, its dependence on obtaining information from the Cancer Register and the medically qualified persons involved in the audit, the public interest in releasing the information would outweigh protecting the privacy of the women on the register, especially since the release would have been limited to the evaluation team. However, the ministry officials at the Cancer Registry did not apply the test under s.9 of the Official Information Act. They instead mistakenly applied rule 11(2)(c)(iii) of the Health Information Privacy Code to the evaluation team’s request. Consequently they required the evaluation team to obtain ethics committee approval for the evaluation task before they would release the data. 6.92 The ethics committee required the evaluation team to obtain the consent of the women before gaining access to the women’s data. However, the evaluation team could not obtain consent from these women because until they saw the Cancer Register data they did not know the women’s identities and so they could not contact them to obtain their consent. This placed the audit team in a "Catch 22"; to obtain consent from the women whose data they wanted to access they needed to know the women’s identities, and they could not know who they were until they saw their data on the Cancer Registry. The Ethics Committee then suggested that the Cancer Registry staff write to the women concerned. The evaluation team considered this was not workable and it did not occur. This state of affairs meant that a crucial part of the evaluation plan, which would identify under-reporting, was not carried out. Once again the Committee learned of this from Professor Skegg’s evidence. 6.93 The Committee was concerned to learn if under-reporting had occurred in other regions. It issued a subpoena requiring the Director-General to produce information from certain specified regions. This information was produced and the Committee made it available to Professor Skegg. However, other information which the Committee also wanted to give to Professor Skegg was withheld by the Ministry under s.74A. The Committee ultimately abandoned its intention of having Professor Skegg carry out an examination of other suspect regions where there was a high incidence of cervical cancer because in September 2000 it was assured by counsel for the Ministry of Health that the work the independent evaluation team was to carry out would identify under-reporting if it had occurred in other regions. 6.94 The Ministry now accepts that the evaluation team’s access to identifiable data on the Cancer Register is governed by the Official Information Act. Correspondence from the Director-General to the evaluation team confirms this. However, as at November 2000 this part of the evaluation was still not being carried out. Ms Grew in her affidavit described it as being the most difficult part of the evaluation project. She said that the Ministry was now to resume responsibility for the cancer audit and that it would engage appropriate expertise under contract where necessary. It seems that, as at November 2000, the medical experts on the evaluation team are unwilling to proceed without the women’s consent now that they have been required by an ethics committee to obtain their consent. This may have changed subsequently; the Committee has not received any further evidence to update its understanding of events. It is not for the Committee to comment on the evaluation team’s actions. These events happened after the public hearings and the Committee has not had an opportunity to question those involved. It cannot, from the written accounts of the various persons involved, which at times are disputed, reach a view on what has occurred. It does, however, record its deep regret that this much-needed exercise still seems to be unable to be carried out. 6.95 What is clear to the Committee is that the mistaken actions of Ministry officials have stopped the cancer audit from proceeding and this may have been avoidable. If the request for information had been handled under the Official Information Act the information could have been given to the evaluation team and they would then have been in a position to contact women for their consent to any further examination of their past treatment. 6.96 The Committee cannot understand why ethics committee approval is necessary for an evaluation of treatment as opposed to research. The guidelines to ethics committees which set out their areas of influence are issued by the Minister of Health. Unfortunately these guidelines are not well expressed. Even though the use of independent consultants to carry out tasks for the Ministry is common, the Guidelines permit internal audits to be carried out without ethics committee approval but they do not expressly include an independent external evaluation. Thus they leave room to argue that ethics committee’s approval is required for these tasks. 6.97 The third phase of the cancer audit stopped at the point where the Ministry incorrectly refused access to essential information. However, the other aspects of the third phase, such as reviewing the management of previous abnormal smears in women and reviewing their cytological and histological results, would involve either access to the National Cervical Screening Register, or to the actual laboratory results. Section 74A would have prevented the evaluation team from having access to the Register, and without consent, it is hard to see how under the current privacy laws it would be possible to access laboratory information. So the third phase of the evaluation may well have encountered other obstacles if the women’s consent was not obtained. 6.98 The need to obtain consent before gaining access to protected information poses practical and technical problems. Women are not always easily traceable. Secondly for the conclusions of an evaluation to be statistically meaningful and therefore informative to medical experts the evaluation exercise must cover a sufficiently large group of women. If only a small number give their consent the exercise will be pointless. The Committee considers that faced with these problems the best choice is to permit medical experts who have been engaged for the purpose of evaluating the Programme to have access to the protected information without the need to obtain women’s consent. It is difficult to see why women might object to an independent evaluation team seeing information to which those medical persons who are involved in their treatment have unrestricted access. If evaluation is seen as an integral part of a woman’s treatment under the Programme there is no difference. 6.99 The Committee was interested to hear from the Ministry’s witnesses on how this legal quagmire had come about. The impression the Committee gained from the evidence was that the Ministry officials were as surprised as it was:
So it seems that the Ministry always intended cancer audits and other evaluation studies of the type being undertaken by the independent evaluation team. However, for reasons which were unknown to the officials who appeared before the Committee the legal foundation to allow these exercises to go ahead had never been put in place. 6.100 In essence, what this legal quagmire reveals to the Committee is a failure on the part of the Programme, when originally designed and subsequently, to ensure that an essential legal foundation was present. Monitoring and evaluation was provided for in the Policies from 1991 onwards. It was recognised by the various expert advisory groups advising the Department of Health in 1989 and 1990, and by international literature, as an essential component of a screening programme. That a necessary legal foundation to allow it to occur is and always has been absent and secondly that Ministry officials could misapply the present law, shows that this essential aspect of the Programme has not been properly thought through. 6.101 The Committee considers that from the outset the Ministry should have ensured that the necessary legal power and ability was available to allow the Programme to be comprehensively monitored and evaluated. Monitoring and evaluation of a screening programme’s performance is a statistical exercise, and unless it involves a sufficient number of women any analysis of the information will not be reliable. The question of whether or not something as important as monitoring and evaluating the Programme’s performance through a cancer audit, or looking at the appropriateness of follow-up and treatment for women with abnormal smears, should not turn on whether or not an evaluation team can obtain the consent of a sufficient number of women to make the evaluation statistically worthwhile. There is nothing unusual about allowing medical experts access to this type of information. The literature on cervical screening programmes emphasises the importance of these exercises. Legal Issues in Relation to Compulsory Imposition of Quality Assurance Processes On Laboratories Reading Cervical Cytology 6.102 The Ministry of Health has maintained in its submissions that until the health reforms of 1993, which introduced a contracts-based system for health funding, it was not possible to compel laboratories to adopt quality assurance measures either directly through a regulation-based quality assurance scheme, or indirectly through a requirement that laboratories be accredited with TELARC or another independent quality control authority. The Committee does not accept that prior to 1993 there was no power to compel laboratories to use quality assurance processes, and it will address this issue separately in this section of the report. However, if the Ministry is correct and there was no power to compel laboratories to adopt quality control measures, then this is a serious systemic flaw in the Programme. A well-designed screening programme would have ensured from the outset that there was clear and specific legal power to require laboratories to adopt quality assurance measures. To design a programme without making sure that this necessary legal power was available is to create a systemic deficiency in the Programme. 6.103 When the Programme was in its design stage the Department of Health, as a government department, was in a position to promote primary legislation to enable compulsory quality assurance processes to be imposed. Given how important quality assurance of laboratory performance was for the Programme, the Department of Health should have taken steps to ensure that the necessary power to impose it was available. At the latest, by the time the Policy 1991 was prepared the Department should have taken steps to learn if it could impose quality assurance on laboratories and if not, the Minister of Health should have promoted legislation to achieve this. The Committee considers that the Department should have obtained a Crown Law opinion on the existing law to compel quality assurance, and if the advice was that this was insufficient it should have advised and encouraged the Minister to take steps to change the legislation. 6.104 The Committee has been told that officials believed that TELARC accreditation was not a problem because most laboratories were moving towards it. Nevertheless, the Department should have ensured that it had the legal power either to impose its own quality assurance scheme under regulations or to require laboratories to become TELARC accredited within the timeframe envisaged in the Policy 1991. These obligations should have been backed up with the power to apply sanctions against non-compliant laboratories. It should have been obvious to the Department that without such legal compulsion there would be some laboratories that would not take steps to become TELARC accredited; or if they did, that any steps towards accreditation would be cursory. There was no economic incentive for laboratories to adopt quality assurance or to become accredited with TELARC. Laboratories were not at risk of becoming liable for compensatory damages as a result of any negligence on their part in diagnosing a test because of the Accident Compensation legislation, which prohibits legal actions based upon personal injury. More is said on this in term of reference seven. Secondly, all laboratories received the same funding for their diagnostic services (they were paid a specific sum per smear test). Quality assurance processes, including TELARC accreditation are an additional expense for a laboratory. For example: TELARC accreditation required a laboratory to upgrade its processes and often its equipment and staff. In this environment there was no economic incentive for a laboratory to adopt quality assurance processes including TELARC accreditation; indeed it was economically rational for a laboratory not to do so as this meant it kept its costs lower for the same return as laboratories which did adopt quality assurance and TELARC accreditation. All of this should have been apparent to the Department at the time. 6.105 Throughout the period that Dr Bottrill was in practice there were other changes to legislation relating to the Programme. Once the decision was made to move to a centralised opt-off register the Health Act 1956 was amended to allow for this, and to allow a patient’s histology to be correlated with her cytology. The Minister of Health was, therefore, successful in introducing this legislative change and having it passed by Parliament. Furthermore new legislation, in the form of the Cancer Registry Act 1994, to make registration of cancer data compulsory was also successfully introduced into and passed by Parliament. The majority of community laboratories supported quality assurance measures including TELARC accreditation, so it is not as if any legislation to compel the adoption of these measures would have been controversial. The bulk of the services provided by community diagnostic laboratories have always been fully funded either directly or indirectly from government funds, so it does not seem unreasonable to require adoption of these measures as a condition of payment. However, the evidence shows that neither the Department nor the Ministry of Health took steps to advise the Minister of the need to promote such legislation and so nothing was done to bring it about. 6.106 Until 1993 community laboratories were funded directly by the Department of Health through regulations made under the Social Security Act 1964. The last regulations to be made under that Act were the Social Security (Laboratory Diagnostic Services) Regulations 1981. The Committee did not find it necessary to look at any of the earlier regulations for the purposes of this report. However hospital laboratories are and always were funded differently. Regulation 10 of the Social Security (Laboratory Diagnostic Services) Regulations did not allow payments to be made to hospital laboratories. The funding of hospital laboratories is and was included in the bulk funding which all hospitals have received from the various government agencies having responsibility for funding public hospitals throughout the various forms of health delivery which have prevailed in New Zealand. 6.107 After the restructuring of health services in 1993 four Regional Health Authorities became responsible for funding the diagnostic services of community laboratories. This was done initially pursuant to notices issued under section 51 of the Health and Disability Services Act 1993, and then as each Regional Health Authority was able to negotiate a contract with the community laboratories in its region, pursuant to that contract. The Regional Health Authorities received their funding from contracts they had made with the Ministry of Health. Subsequently the Regional Health Authorities were merged into one entity which ultimately became the Health Funding Authority. At the time of the Inquiry the Health Funding Authority was in the process of being merged with the Ministry of Health to form a new Ministry. 6.108 The Midland Regional Health Authority, which was the authority responsible for the region in which Gisborne Laboratories operated, did not complete the negotiation of its contract with the community laboratories in its region until after the business of Gisborne Laboratories had been sold to Medlab Hamilton and Dr Bottrill had retired. All the payments for cervical cytology read at Gisborne Laboratories were made under either regulation 8 of the Social Security (Laboratory Diagnostic Services) Regulations 1981 or notices issued under section 51 of the Health and Disability Services Act 1993. Neither form of payment was linked with requirements for quality assurance. It is a feature of the funding of community laboratories throughout the time Dr Bottrill practised that the government agencies responsible for paying for their services did no more than to rely on the professional qualifications of the persons who worked in the laboratories to ensure that every laboratory performed competently. 6.109 Between 1990 and March 1996 the only direct control on community laboratories that was relevant to terms of reference two and three was the Medical Laboratory Technologists Regulations 1989. Regulation 9 of these regulations required cervical smear test reading to be carried out by a medical practitioner, a registered medical technologist or someone working under the supervision of either of these persons. It is notable that the regulations did not require the medical practitioner to be a registered pathologist. Dr Boyd told the Committee that under the Medical Practitioners Act 1968, which was the legislation in force throughout the time Dr Bottrill was in practice, the medical profession was self-regulating and that:
Furthermore under the Medical Practitioners Act 1968 once a medical practitioner had obtained registration on the specialist register of his or her particular speciality there was:
This might suggest that there was little that the Department/Ministry of Health could do to ensure medical practitioners retained their competency in their field of practice. However, Dr Boyd acknowledged in evidence that the Minister of Health could indirectly exert control on community laboratories through the Social Security (Laboratory Diagnostic Services) Regulations 1981. And from 1993 onwards the s.51 notices gave the Regional Health Authorities sufficient authority to impose quality control requirements on community laboratories Social Security (Laboratory Diagnostic Services) Regulations 6.110 Under the scheme of the Social Security (Laboratory Diagnostic Services) Regulations payments for publicly funded diagnostic services performed at community laboratories were made to persons who qualified under the regulations as "recognised pathologists." The regulations made no provision to pay community laboratories which operated as limited liability companies for the services they provided. Dr Boyd informed the Committee that the payments to "recognised pathologists" included payment for those services that were actually performed by laboratory technicians such as cytotechnologists or cytoscreeners. He said that the "recognised pathologist was expected to provide appropriate supervision of other laboratory staff, and that this meant that the head pathologist at a laboratory received payment for the services at that laboratory, and in turn he or she was expected to ensure adequate service:
6.111 Regulation 5 gave the Minister of Health the power to recognise medical practitioners as pathologists for the purpose of the regulations. The Minister was assisted in the exercise of this power by the Laboratory Services Advisory Committee. Dr Boyd said that this Committee advised the Minister on aspects of the Laboratory Diagnostic Services Benefit, including its administration. Dr Boyd also said that complaints about the quality of service at a laboratory which came to the Department’s attention could be taken to this committee for advice. 6.112 Later in his evidence Dr Boyd explained to the Committee how pathology was recognised as a speciality of medicine and that pathologists could apply to have their names included on the specialist register under the Registration of Specialists Regulations 1971. As a separate process the Department maintained and published a list of specialists eligible to claim specialist benefits under the Social Security Act 1964. Included in this list would have been those pathologists whom the Minister of Health had "recognised" pursuant to regulation 5 of the Social Security (Laboratory Diagnostic Services) Regulations. Dr Boyd informed the Committee that the Laboratory Services Advisory Committee dealt with applications for recognition as a pathologist under the Social Security (Laboratory Diagnostic Services) Regulations. He said:
6.113 Regulation 6 enabled the Minister to refuse to recognise a medical practitioner as a pathologist. Under regulation 6(2) the Minister could make the recognition of a medical practitioner subject to any conditions which he or she thought fit to impose, so long as they were not inconsistent with the regulations. Under regulation 6(3) the Minister could, on giving one month’s written notice in writing, revoke any recognition given by him or her under the regulations or alter the conditions attached to the recognition. 6.114 It appears then that the Minister had some measure of control over community laboratories through the decision to grant recognition to a pathologist or to impose conditions on the recognition of a pathologist; because this determined whether or not the pathologist could be paid for providing diagnostic services. However, there was no attempt to use the regulations to impose quality assurance on community laboratories under Department of Health supervision. The Committee heard no evidence to indicate that Department of Health officials had ever considered the possibility of the Minister using the power to impose conditions under regulation 6(2) to specify a requirement for quality control and the form it should take. The Committee did hear evidence of the Ministry requesting legal advice in 1992 on whether or not it could impose TELARC accreditation as a condition of payment. The evidence the Committee heard shows that Department of Health officials made one attempt to introduce a quality control measure into community laboratory practice in the early stages of the National Cervical Screening Programme. Dr Boyd told the Committee that, once the National Cervical Screening Programme was in operation, the Department had sought advice on making laboratory accreditation with TELARC, or a similar authority, a condition of payment under the Social Security (Laboratory Diagnostic Services) Regulations. However, the Department was advised by one of its inhouse solicitors that it had no power under the regulations to do this. 6.115 After the close of the formal hearing, the Committee sought written submissions on whether or not the regulations gave the Department the power to impose a quality assurance scheme as a condition of payment. Counsel for the women affected filed submissions which contended that the regulations gave the Minister the authority to impose a quality assurance regime as a condition of recognition under regulation 6(2). The Ministry of Health filed written submissions which had been prepared by its inhouse solicitors. They submitted: that the Social Security Act 1964 under which the regulations were made did not authorise regulations which imposed a quality control regime on pathologists; and that in so far as the Social Security (Laboratory Diagnostic Services) Regulations purported to allow the imposition of conditions relating to the recognition of a pathologist under the regulations they were ultra vires and therefore unlawful. In addition they submitted that, for the same reason that the current regulations were ultra vires, it would not have been possible to make new regulations which provided the authority to impose quality control on laboratories 6.116 Since the Ministry of Health now submits that regulation 6(2) of the Social Security (Laboratory Diagnostic Services) Regulations is ultra vires it is necessary to look at the regulation-making power in the Social Security Act 1964 in order to determine if the Minister/Department of Health could as a condition of payment impose a quality assurance scheme or require laboratories to be accredited with TELARC or any other similar authority. There would have been no legal impediment to imposing such a scheme on hospital laboratories as these were funded through the bulk funding the Department provided to Area Health Boards. The bulk funding was provided via a contract system with the Area Health Boards, therefore, it should have been legally possible to impose by contract a requirement that hospital laboratories reading cervical cytology participate in a quality assurance scheme which mirrored any scheme imposed by regulation on community laboratories. 6.117 Essentially the Ministry of Health’s submission is that the very general power to make regulations, which was to be found in s.132 of the Social Security Act, was not as wide-ranging as it appeared to be. The Ministry contends that the power in s.132 must be read in the context of the scheme and purpose of the Act. And since the purpose of the Act was to provide benefits to persons, including health benefits, the Act’s scheme and purpose did not permit the imposition of conditions on the recognition of persons eligible to receive payment of these benefits. Following on from this submission the Ministry contends that it would not have been lawful to amend the Social Security (Laboratory Diagnostic Services) Regulations by including a specific regulation imposing a quality assurance regime or a requirement for accreditation on laboratories. The submission is surprising. The regulations were in place from 1981 until 1993 and throughout that time no-one questioned whether or not they were lawful. They would have been prepared by Ministry solicitors and Parliamentary counsel. 6.118 To support its submissions the Ministry of Health filed an affidavit from Mr Jamieson, Parliamentary Counsel. The thrust of Mr Jamieson’s affidavit was that a new regulation under the Social Security (Laboratory Diagnostic Services) Regulations which created a quality assurance scheme, or expressly provided the Minister with the power to impose a requirement for laboratories to be TELARC accredited before being eligible for payment, was not possible, as it was likely to be ultra vires. He said that if he had been asked to prepare such a regulation he could not have supported doing so. 6.119 The difficulty with this submission is that the Committee is aware that regulation 6(2) of these regulations already expressly permitted the Minister to impose conditions on recognition of pathologists, which in turn affected whether or not they were paid for their services. Regulation 6(2) would have been prepared in conjunction with Parliamentary Counsel and would have required Parliamentary Counsel’s approval. Therefore, the Committee must balance against the information it now has from Mr Jamieson its knowledge that on an earlier occasion another Parliamentary Counsel saw no difficulty with including in these regulations a power to impose conditions on pathologists. 6.120 While the recent evidence from Mr Jamieson and the inferences to be drawn as regards the opinions of an earlier Parliamentary counsel are interesting, ultimately it is a question of statutory interpretation. Traditionally legal opinions on matters of domestic law have not been admissible in evidence and the present conflict of evidence shows that there is good reason for that. 6.121 The Ministry submits that reg 6(2) offends a well-recognised principle that regulations made under provisions like s132 can only be for the purpose of carrying into effect what is already in a statute; and they cannot widen, depart from or vary the legislative scheme in their empowering Act. The Ministry’s view is that ss. 123 and 116 define the relevant purposes of the Social Security Act when it comes to payment of benefits for laboratory services. It contends that s.123 of the Act provides a scheme for making payments to specialists and if there is any power to confine making payments to specialists (pathologists) it must be found in that section and not in any regulation made under s132. Because under s.123 there was no power to make payments conditional on the performance of certain acts, it could not be done. The Ministry also submits that it was unlawful for the regulations to give the Minister a general discretionary power to recognise pathologists. It contends that this is an unlawful delegation and that the criteria for recognition must be set out in the regulations. 6.122 The Committee accepts that the scheme and purpose of the Social Security Act can confine a general regulation-making power like s.132. However, it does not accept the remainder of the Ministry’s submissions on this issue. The Ministry’s submissions rely upon a particular interpretation of s.123 of the Social Security Act which the Committee does not accept. The Committee considers that s.123 does not apply to the Social Security (Laboratory Diagnostic Services) Regulations. The Committee’s view is that s.116 is a stand-alone provision to pay supplementary benefits which contains its own power to make regulations for that purpose. The only provisions that were relevant to the power to make payments to laboratories were ss.116 and 132. 6.123 The Social Security Act made wide provision for payment of benefits of many types. Part II of the Act provided the statutory mechanism for a public health system. It made provision for a number of health related benefits. Section 89 sets out the classes of benefits; these are: medical benefits; pharmaceutical benefits; hospital benefits, maternity benefits, and supplementary benefits. 6.124 However, when the Act it looked at as a whole it appears that there is a divide between supplementary benefits under s.116 and the other benefits, including payments to specialists. Section 116(1) refers back to a series of benefits, these are: medical benefits; pharmaceutical benefits; hospital benefits; and maternity benefits. Section 116 provides:
Section 116(2) continues :
In the Committee’s view because s.116(2) deems laboratory services to be within the provisions of s.116(1) this indicates that were it not for s.116(2) such services would not come within subsection 116(1). In other words, supplementary benefits are additional to and separate from the other benefits in Part II. When the classes of benefits provided in the foregoing provisions to s.116(1) are examined, they do not appear to cover laboratory services. Furthermore, if laboratory services did come within one of those classes there would have been no need for the legislature to include laboratory services in s.116(2). Secondly, s.123(2) specifically refers to regulations made under s.116(1) or s.123(1) of the Act. This sentence is disjunctive and reinforces the divide between s.116 benefits and other benefits. For these reasons the Committee considers that s.116 coupled with s.132 provides sufficient authority to make regulations to pay for laboratory services and that none of the other provisions in Part II of the Social Security Act are relevant to these payments. 6.125 Given that laboratories received public money for their services it does not seem inconsistent with the Act that laboratories should be subject to providing those services in accordance with certain conditions. The Committee considers that the imposition of a quality assurance scheme or TELARC accreditation was something that was incidental to the execution of the Act’s specific provisions. Therefore, the Committee considers that regulation 6(2) was within the scope of the combined regulation making powers of s.116 and s.132. Hence, it was legally possible to impose quality assurance and accreditation requirements as a condition of payment under regulation 6. It also considers that there is nothing in conflict with the Act to permit the Minister to recognise pathologists for the same reasons. 6.126 Having concluded that regulation 6(2) was lawful, the Committee must now consider whether or not that regulation permitted the imposition of a scheme of quality assurance measures which were subject to inspection by persons to whom the Director-General of Health had delegated this responsibility. The scheme and purpose of the regulations was to direct payment to those medical practitioners who had satisfied the Minister that they should receive recognition as pathologists, and to provide a measure of control over the performance of recognised pathologists. For example regulation 6(2) specifically permitted the Minister to impose conditions which made all equipment and apparatus used by the pathologist subject to inspection by persons authorised by the Director-General of Health. The express reference in regulation 6(2) to inspecting equipment and apparatus used by the pathologist can only have been for the purpose of ensuring it worked properly and did not impact badly on the pathologist’s performance in the laboratory. The express reference to inspection of laboratory equipment and apparatus being made subject to conditions shows that the authority to impose conditions, under regulation 6(2), was not intended to be confined to the pathologist but could extend to his or her work environment as well. 6.127 There is nothing about the imposition of a requirement to carry out quality assurance or coupled with a power to inspect its discharge that is inconsistent with the regulations. Once quality assurance had become an acceptable part of a pathologist’s laboratory practice there was no legal impediment to making it a condition of recognition under regulation 6(2). The use of quality assurance would have been another feature of a pathologist’s work environment which affected the quality of his or her performance, and which was capable of being inspected and assessed like the laboratory equipment and apparatus the pathologist used. By the early nineteen nineties quality control measures were operating in a number of New Zealand community laboratories. In Australia quality control in the form of accreditation with the Australian equivalent of TELARC had been a mandatory condition of a diagnostic laboratory receiving Medicare funding since 1987. 6.128 In the Committee’s view by the early nineteen nineties quality assurance was seen as a standard practice of good pathologists, and therefore it would have been a reasonable condition to impose under regulation 6(2). Given that pathologists’ services were being funded from public funds and they were a health service that was provided for the public good an attempt by the Minister to ensure that the services being funded were of good quality would have complied with the Minister’s legal obligations to act reasonably and in accordance with the regulations. 6.129 For the same reason that it considers regulation 6(2) enabled the Minister to impose a quality control scheme directly on pathologists the Committee can see no reason why the Minister could not have made accreditation with an agency such as TELARC a condition under regulation 6(2). The demands of accreditation would have improved the performance of those who worked in a laboratory in much the same way as the direct imposition of a quality control scheme under regulation 6(2). For the same reasons that the Committee considers the regulations permitted a regulatory quality control scheme to be imposed, the Committee is at a loss to see how it could be thought that the regulations did not permit a condition requiring accreditation with TELARC. The Committee’s view that the regulations permitted the imposition of mandatory accreditation as a condition of pathologists’ recognition under the regulations was accepted as correct by the Ministry’s counsel at the hearings before the Committee. 6.130 The legal advice the Department of Health received from its inhouse solicitor on the use of the regulations to impose mandatory accreditation is sparse. It is no more than paragraphs and gives no reasons to support the conclusion reached. There was no evidence that the advice was ever queried, or that a second opinion was sought. There was no evidence of any request for advice on this subject being made to the Crown Law Office. Ms Judith Glackin who a senior Ministry of Health official. She said that if she had received such advice she would have queried it. The Committee considers that the response Ms Glackin outlined to it is appropriate and it should have been taken at the time. It is unfortunate that the advice of the inhouse solicitor was accepted without demur. By not pursuing this matter further the Department of Health officials who sought the legal advice lost an opportunity to ensure that the government policy to require TELARC accreditation by 1993 was achieved. 6.131 The Government Policy for National Cervical Screening (1991) contemplated that all laboratories reading cervical cytology would be accredited by 1993. If the Minister had imposed accreditation as a requirement of payment under regulation 6(2) there could have been a lead-in period to allow laboratories sufficient time to bring their practices up to accreditation standard. At the time approximately 22 laboratories were already accredited. Once the chosen lead in period had expired all cervical cytology work could have been directed to the accredited laboratories. There may have been resistance from some laboratories which found it difficult to obtain accreditation, however the Minister and Department of Health officials should have been prepared to respond to such resistance and to meet any legal challenge that was brought. The need for accreditation of laboratories by 1993 was part of the government’s policy for the National Cervical Screening Programme; it was a sensible policy which would have been of direct benefit to women having cervical smear tests and of indirect benefit to their families through the health benefits which women enjoyed as a result of having cervical smear tests. The Minister and the Department of Health should have been prepared to do whatever they each had to do to ensure the policy was achieved. Funding Under Section 51 of the Health and Disability Services Act 1993 6.132 When the public health system was restructured in 1993 a number of the operational functions formerly carried out by the Department of Health passed to four Regional Health Authorities. One of these functions included the tasks which Department officials had carried out under the Social Security (Laboratory Diagnostic Services) Regulations. The regulations were repealed by the Health Reforms (Transitional Provisions) Act 1993. The new health system was introduced through the Health and Disability Services Act 1993. In consequence of the restructuring of the health system the Government Policy for National Cervical Screening (1991) was updated in October 1993 to take into account the structural changes. The change to the Policy document has been outlined in the section on Term of Reference Two. 6.133 With the restructuring of the health system came a shift in attitude towards health management. The new approach relied upon a series of contracts between health funders and health providers to manage health delivery in place of the traditional exercise of executive authority. The new Ministry of Health provided bulk funding to the four Regional Health Authorities pursuant to contracts negotiated annually. In turn the four Regional Health Authorities each contracted annually with health providers for the services required to maintain the publicly funded health system. Within the various contractual arrangements provision was made for medical laboratory diagnostic services and cervical screening. 6.134 The contracts between the Regional Health Authorities and the health providers were unable to be agreed immediately, and as an interim measure the Regional Health Authorities obtained services from health providers by issuing notices under s.51 of the Health and Disability Services Act 1993. The s.51 notices were issued on 23 June 1993 and took effect from 1 July 1993. They remained in force until the Regional Health Authorities had negotiated a contract with their health providers. The contract for laboratory diagnostic services between Gisborne Laboratories and the Midland Regional Health Authority was not negotiated until the end of 1996; and the formal document was not executed until 26 February 1997. By this time there had been a change of ownership as Dr Bottrill had retired in March 1996. Throughout the time that he practised under the new system the s.51 notices were in effect. 6.135 The Committee heard evidence from Dr Boyd of the Ministry of Health and Mr Mules the former Chief Executive of the Midland Regional Health Authority about the interim management of health services under the s.51 notices. Dr Boyd said that in general the approach of the Regional Health Authorities to cervical screening was to continue with the previous arrangements the Health Department had with health providers. Mr Mules confirmed that this had occurred in regard to Midland Regional Health Authority’s arrangements for laboratory services. He also acknowledged that the Midland Regional Health Authority could have specified minimum quality assurance provisions in the s.51 notice but had not done so. 6.136 Section 51 of the Health and Disability Services Act gave Regional Health Authorities sufficient authority to enable them to require laboratories to become accredited with TELARC or to adopt a quality control scheme of the Regional Health Authority’s design. Section 51(1) allowed the regional health authority to give notice of the terms and conditions on which the authority would pay someone. Acceptance of payment was deemed to constitute acceptance of the terms and conditions of payment. Any change of terms and conditions required four weeks’ notice. Section 4 set out the scheme of the Act which was to provide for the people of New Zealand the best health and the best care. A change of condition of payment to require TELARC accreditation would have been entirely consistent with the Act’s scheme. Provided the legal requirements for notice and consultation were followed it would have been possible to alter the s.51 notices to include this requirement. 6.137 No attempt was made to use the powers under s.51 of the Health and Disability Services Act 1993 to impose quality control measures including TELARC accreditation on laboratories. The situation remained as it was before the revocation of the Social Security (Laboratory Diagnostic Services) Regulations. Rather than use the powers available to it under s.51 to introduce improvements by requiring TELARC accreditation of laboratories the Midland Regional Health Authority focussed on achieving changes in health service provision through contractual negotiations with health providers. This focus was in accordance with government policy. Mr Mules informed the Committee that while it was possible for a Regional Health Authority to manage using s.51 notices this was seen as undesirable and contrary to the Policy Guidelines for Regional Health Authorities issued by the Minister of Health. 6.138 The Midland Regional Health Authority’s approach may have been consistent with the philosophy of the time, however, it made the introduction of TELARC accreditation as envisaged in the Government Policy for National Cervical Screening (1991) and in the 1993 update of the Policy subject to the time taken to negotiate the general contracts with laboratories. These negotiations were subject to delays unrelated to TELARC accreditation. Mr Mules said in evidence that:
6.139 The result of handling matters in this way was that the introduction of a quality control measure for cervical screening which had always been seen as necessary, and which initially was intended to be in place by 1993, was delayed until the end of 1996. This delay enabled Dr Bottrill and the locums he employed from time to time to continue to practice without quality control. Has Unacceptable Under-Reporting Occurred Elsewhere? 6.140 The Committee cannot be satisfied that the systemic problems have not resulted in unacceptable under-reporting in other regions in New Zealand. The Committee has seen evidence in looking at the files of the Gisborne women affected that on occasions slides read at Gisborne Laboratories are interspersed with slides read at other laboratories. The other slides have sometimes been read as normal. The fact that these normal slides appear with slides which were misread at Gisborne Laboratories as normal, and were later found to be abnormal, is a cause for concern. The slides read at other laboratories have not been reviewed, and so why they were read as normal is unknown. 6.141 In New Zealand the Programme has prepared national statistics which determining the national average for reporting high-grade abnormalities, and it has then checked to see whether or not individual laboratories are within a particular range of that average. These statistics were criticised by witnesses before the inquiry. This approach of using the national average as a benchmark was also used by the Health Funding Authority’s National Laboratory Review study written by Mr Du Rose. The difficulty with this approach is that because laboratory performance has never been monitored and evaluated, there can be no certainty that the national average has not itself been fundamentally influenced by under-reporting. Comparison with other countries (for example Australia), is not always helpful because New Zealand has a higher rate of cervical cancer. The notion of using national averages and seeing where individual laboratories were placed in comparison with that average was criticised by Professor McGoogan. Her view was that a standard should be set and laboratories compared to that standard. The difficulty, however, with setting a standard is knowing what is an expected percentage of high-grade abnormalities. In New South Wales, the standard for high-grade abnormalities is 0.5%, but there is a lower cervical cancer rate in that state. 6.142 In the Committee’s view there is little comfort in taking the national average and seeing where laboratories lie in comparison with that average. Because it has been derived from a time when laboratories were not monitored and evaluated, and not all of them were TELARC accredited or subject to any compulsory quality control, it is possible that the national average is not an accurate reflection of the rate of high-grade abnormalities. For example Professor Skegg pointed out to the Committee that the Sydney re-read of Gisborne smear tests had produced a high-grade reporting rate of at least 2.5% and maybe 3.7%. Dr Bottrill’s high-grade reporting rate was 0.5%. The figures on which the national average is based include Dr Bottrill’s rate of 0.5%. If, however, the Sydney re-read high-grade rate is more correct the national average will have been calculated using at least one false reporting rate. There would only need to be a few similar incidences before the national average would become flawed. Thus, using it as a measure to determine if there are other laboratories which are under-reporting may not be helpful to answering this question. This is another reason why the independent evaluation by the Otago University team must be carried out. 6.143 The Committee was concerned to know what reliance it could place on the National Laboratory Review study written by Mr Du Rose. There was conflicting evidence on whether or not the review should set the Committee’s mind at rest regarding under-reporting in other regions. The Ministry of Health relies upon the Du Rose study to establish that there is no real cause for concern for women in other regions. However, other witnesses and parties had reservations about the study. 6.144 Professor Skegg was one of these witnesses. He told the Committee that he had doubts about the Review. He was critical of it being based only on cervical smears and not on women. He said he considered that to be a fundamental weakness, because the proportion of smears reported as abnormal can be markedly affected by the patterns of medical practice in different areas. Where it is the practice to take smears at or after a diagnosis of cervical cancer there will inevitably be a higher reporting rate than in those areas where the clinicians do not follow this practice. Professor Skegg was also critical of there being no adjustment in the data for factors such as age or socio-economic status or ethnicity. He considered that the use of places having either a higher or lower than average Maori population was an extremely crude approach to the problem. He said that given that there was a screening register with information about the smear histories of individual women, he could not understand why the study used proportions of smears and not women. 6.145 The use of places having a higher or lower than average Maori population as an indicator of a higher or lower rate of high-grade abnormalities concerned the Committee. The Committee noted that the information on the population of Maori was derived from demographic statistics and deprivation statistics. It seems that the Health Funding Authority did not use the Register to extract data about Maori women. The Committee was concerned to learn if the Kaitiaki Regulations had been an obstacle to using the Register. The Committee did not receive an adequate explanation for why the ethnicity data on the Register were not used for this purpose. The use of demographic and deprivation statistics seemed a clumsy tool by comparison. This information should have been on the Register and it should have been accessible to someone like Mr Du Rose. 6.146 The Committee raised this issue with Professor Skegg and asked him, as an epidemiologist, what did he think of that approach.
6.147 More significantly Professor Skegg’s view was that the Du Rose study may not have identified Gisborne Laboratories as an outlier if it had been simply another laboratory in the study. Professor Skegg referred to evidence from the Du Rose study which gave Gisborne Laboratories a high-grade reporting rate of 0.57% which was above the 0.5% threshold the study had set as a benchmark to identify outliers. Four laboratories in New Zealand had a lower rate of reporting high-grade abnormalities than Gisborne Laboratories. He also referred to evidence which had emerged from the Inquiry which showed that of 216 women with high-grade abnormalities or cancer, Gisborne Laboratories had reported only 37 of those as high-grade or cancer. Professor Skegg said that this gave Gisborne Laboratories a false negative rate of more than 80% and yet when the tables in the Du Rose study were looked at Gisborne Laboratories had a high-grade reporting rate of 0.5%. Thus the laboratory did not emerge as a clear outlier. Furthermore the study was not able to identify its very high false negative rate. Professor Skegg said:
6.148 The study left Professor Skegg uncertain as to whether or not there was a systemic problem of under-reporting in New Zealand. His concern was that overall the rate of high-grade reporting in New Zealand was much lower than the Sydney re-read rate and that raised the question of whether or not there was systemic under-reporting:
6.149 Ultimately Professor Skegg concluded :
6.150 When Professor Skegg was asked what could be done to find out whether there are such problems, his view was that the national evaluation should go ahead. Professor Skegg stated :
6.151 There were other technical difficulties identified regarding the way in which the Du Rose study was set up. Indeed the study accepts that " it is does not represent a thorough assessment and evaluation of the quality of cervical cytology services". Dr Medley, who was engaged by the Health Funding Authority to assist with setting up the study said the Committee could not rely upon it to reach a view as to whether or not under-reporting was isolated to Gisborne. The Committee was left unsatisfied as to whether or not under-reporting is or had occurred in other regions of New Zealand. It considers that the question of the discrepancy between the Douglass Hanly Moir Pathology high-grade reporting rate and the New Zealand average requires urgent attention. Conclusion 6.152 Ministry witnesses have described the Programme as successful because it has reduced the rate of mortality and morbidity of cervical cancer in New Zealand. It may have done so. However, in the Gisborne region, 16 women developed cervical cancer. Their smear tests were read as normal at Gisborne Laboratories. The same smear tests were subsequently re-read at Douglass Hanly Moir Pathology as high-grade or cancer. In the Committee’s view, a successful well-designed and well-run screening programme does not allow something like this to happen. 6.153 The need for quality control of laboratories reading cervical cytology, quantitative performance standards, a central computerised registration system linking cytology, histology and cancer morbidity and mortality data, easy access to relevant reliable statistical information, routine monitoring and evaluation and the consequences of not having these features in place are illustrated by what occurred in the Gisborne region. These essential components of a screening programme were not present throughout the time Dr Bottrill was in practice. Any attempts the Programme may have made at achieving these essential components were not effective; that is shown by the unacceptable level of under-reporting which occurred. A screening programme which had these essential components in place would not have permitted Dr Bottrill to practice as he did; it also would have been able to detect unacceptable levels of under-reporting. 6.154 The systemic problems occurred because there was a failure to appreciate that a cervical screening programme has certain essential features and that these must be in place from the outset for the National Cervical Screening Programme to be effective. The Programme did not begin with all the essential features in place; nor were they all in place during the Programme’s design stage, implementation stage or operational stage. Secondly, this failure to recognise what features could not be compromised if the Programme was to be effective meant that it was originally shaped to fit and later forced to accommodate the prevailing ideologies on health delivery. Many of its features and functions were split between regional health agencies (area health boards and regional health authorities) and the central health agency (Department/Ministry of Health) for reasons which were not conducive to a well run screening programme. The end result was that the Programme was vulnerable to systemic failures. Throughout the life span of the Programme it has been shaped to fit the Procrustean bed of the prevailing ideologies on health delivery. This has created systemic problems in the Programme and has been at the expense of its effectiveness.
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