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UNDER THE HEALTH AND DISABILITY SERVICES ACT 1993 IN THE MATTER OF THE MINISTERIAL INQUIRY INTO THE UNDER-REPORTING OF CERVICAL SMEAR ABNORMALITIES EVIDENCE OF JUDITH MARGARET GLACKIN MINISTRY OF HEALTH i TABLE OF CONTENTS PART I: QUALIFICATIONS AND EXPERIENCE ..................................... 1 PART II: CHRONOLOGY BACKGROUND OF THE NCSP: 1989 TO 1999 (DEPARTMENT/MINISTRY OF HEALTH PERSPECTIVES)... 2 Introduction .................................................................................................... 2 1989 ................................................................................................................ 4 The National Cervical Screening Implementation Unit ........................ 4 The 1989 Ministerial Review ............................................................... 5 The Expert Group ................................................................................. 8 1990 ................................................................................................................ 9 The National Cervical Screening Programme (NCSP) develops ......... 9 Expert Group Inquiries and Reports ................................................... 11 Change of Government: November 1990 ........................................... 15 1991 .............................................................................................................. 16 Early Implementation.......................................................................... 16 Revised Policy Statement for the NCSP: The 1991 Policy ................ 18 1992 .............................................................................................................. 22 Planning for the proposed health sector reforms ................................ 22 1993 .............................................................................................................. 24 Proposal to reconfigure the Register ................................................... 24 Early monitoring of the NCSP ............................................................ 25 The 1993 legislative changes .............................................................. 25 The 1993 NCSP Policy ....................................................................... 27 The roles of key agencies after the reforms ........................................ 30 1994 .............................................................................................................. 32 PHC advice and consultation on revised NCSP policy ...................... 32 Review of advisory committees .......................................................... 33 Other developments ............................................................................ 34 1995 .............................................................................................................. 36 General progress ................................................................................. 36 ii 1996 .............................................................................................................. 38 Ministry review of accountabilities for the NCSP .............................. 38 Changes to the role of National Co-ordinator ..................................... 41 The 1996 NCSP policy ....................................................................... 42 Other issues ......................................................................................... 42 Change of government ........................................................................ 43 1997 .............................................................................................................. 44 General progress ................................................................................. 44 Coalition Government - changes to the health sector ......................... 45 The planned evaluation of the NCSP .................................................. 46 1998 .............................................................................................................. 46 Transfer of the NCSP to the HFA ....................................................... 46 Other publications ............................................................................... 47 1999 .............................................................................................................. 48 The misleading of cervical pathology in Gisborne ............................. 48 NCSP evaluation progress .................................................................. 50 Current Ministry of Health responsibilities for the NCSP .................. 51 PART II: THE PROGRAMME IN TAIRAWHITI...................................... 52 Demography of the Gisborne region ............................................................ 52 Geographical profile ........................................................................... 52 Population profile ............................................................................... 54 Ethnicity of Gisborne women aged 20-69 years ................................. 54 Socioeconomic profile ........................................................................ 55 Relative rate of deaths from cervical cancer in Tairawhiti........................... 55 Cervical screening in Tairawhiti before the establishment of the NCSP ..... 56 The NCSP in Tairawhiti ............................................................................... 58 Enrolment on the Register in Tairawhiti ...................................................... 63 PART III: THE REGISTER ......................................................................... 65 Introduction .................................................................................................. 65 Description of the Register, and how information is obtained and held ...... 65 Development of the National Cervical Screening Register prior iii to reconfiguration in 1997 ............................................................................ 69 Changing the Register from opt-on to opt-off (1993) .................................. 73 Reconfiguration of the Register ................................................................... 75 Incorporation of histology on the Register ................................................... 77 Maori women‟s data ..................................................................................... 81 Pacific women‟s data ................................................................................... 81 Cancer Registry ............................................................................................ 81 PART IV: MONITORING AND EVALUATION OF THE NCSP ............ 83 Introduction .................................................................................................. 83 Overview of the sector accountability arrangements ................................... 84 Ministry to Minister/Parliament.......................................................... 84 AHB/funder to Department/Minister .................................................. 85 Formal monitoring of the NCSP .................................................................. 86 Monitoring of area health boards by the Department of Health, 1990-93 ............................................................................................... 86 Ministry of Health Monitoring of the Funder ..................................... 87 The 1993 policy statement ............................................................. 87 NCSP Requirements in Funding Agreements ................................ 89 Quarterly reports on funder performance ....................................... 93 Operational monitoring of the NCSP ........................................................... 97 NCSP Programme Managers .............................................................. 97 NCSP National Co-ordinator .............................................................. 98 Advisory Committees ....................................................................... 101 The Register as a monitoring tool ..................................................... 102 Evaluation .................................................................................................. 104 Early recommendations .................................................................... 106 The Ministerial Review ................................................................ 106 Pilot projects ................................................................................ 108 The CSAC and evaluation ................................................................ 108 Evaluation referred to in policy statements ...................................... 110 Ministry of Health evaluation ........................................................... 113 iv Health outcome targets for cervical screening ........................................... 114 EXHIBITS PRODUCED BY JUDITH MARGARET GLACKIN............ 121 APPENDIX ................................................................................................ 127 1 I, JUDITH MARGARET GLACKIN of Wellington say: PART I: QUALIFICATIONS AND EXPERIENCE 1. My name is Judith Margaret Glackin. I am currently employed by the Ministry of Health as Acting Deputy Director-General, Policy. I hold a BA degree and a Diploma in Training and Development. I am authorised to give evidence on behalf of the Ministry. 2. I joined the then Department of Health in 1978, and was employed initially as a Staff Training Officer and later an Executive Officer, until I took time out of the workforce for full-time child care in 1984. I returned to the Department in March 1988, and held various senior executive and advisory positions. From March 1993 until January 1996 I worked as a Senior Analyst in three areas of the Ministry - Population Health Services, Health Sector Development, and in Sector Funding and Purchasing as the project manager for the 1996/97 Regional Health Authority Policy Guidelines. 3. In January 1996 I was appointed Manager, Prevention Policy in the Ministry‟s Public Health Group. In that position I was responsible for the Ministry‟s policy and operational roles in relation to the National Cervical Screening Programme (NCSP). This included national co-ordination of the Programme and the National Cervical Screening Register, until April 1998 when these were transferred to the Health Funding Authority. In addition, I was responsible for policy advice to the Minister on the NCSP, and policy input to the Ministry‟s monitoring of regional health authorities (later 2 Transitional Health Authority and Health Funding Authority), and to the Ministry‟s evaluation of the NCSP. 4. In October 1998, following the establishment of the Ministry‟s Policy Branch, the previous policy functions related to the NCSP became part of the Population Health and Social Policy portfolio, and responsibility for the NCSP evaluation became part of the Monitoring and Evaluation portfolio. Both portfolio managers have reported to me since I was appointed as a Policy Director in December 1998. I have been Acting Deputy Director-General since February 2000, and am currently responsible for all Policy Branch functions, with the exception of those projects related to the changes in the health sector to be implemented later this year. 5. My evidence mainly focuses on policy and operational issues relating to cervical screening, and also puts the programme in the context of changing accountability arrangements in the health sector. PART II: CHRONOLOGICAL BACKGROUND OF THE NCSP: 1989 TO 1999 (DEPARTMENT/MINISTRY OF HEALTH PERSPECTIVES) Introduction 6. This section of the Ministry of Health evidence outlines the development and implementation of the National Cervical Screening Programme (NCSP) from 1989 until 1999. 7. The NCSP was the first major population-based screening programme to be introduced in New Zealand. Because of the 3 complexity of a population-based screening programme, particularly in its initial stages, the then Department of Health and the NCSP drew heavily on expert advice. This was, and is, the usual method used by the Department and now by the Ministry, in complex areas where there is a need to obtain a New Zealand concensus on best practice. 8. Many of the committees advising the NCSP were Ministerial committees. This means that they were appointed by the Minister, had specific Terms of Reference, and reported to the Minister. The members were generally nominated by professional bodies and consumer groups, or were appointed for their specific expertise. The Department of Health (until 1993) and then the new Ministry serviced the committees i.e. organised and attended meetings, provided secretarial servicing (agenda, minutes, correspondence etc), and paid fees set through the State Services Commission. 9. The chronology which follows, therefore, links the advice provided by expert and advisory committees into the stages of the development of the NCSP. The Terms of Reference and membership of various committees are provided in an Appendix to this evidence. 10. The chronology also includes reference to the changes in the health sector and their influence on the development, implementation and accountabilities of NCSP. The chronology endeavours to provide time sequencing and contextual perspective to the development and implementation of the NCSP. Context is critical when examining the development of one aspect of the programme, such as systems for quality control of laboratories providing cytology services to the NCSP. These are discussed in the second part of Dr Boyd‟s 4 evidence on behalf of the Ministry. By context I mean not only the sector restructuring throughout the late 1980s and 1990s, but also the complexities of a national screening programme; the need to get certain structures in place and processes working before the programme could meet the high expectations of those involved; the competing priorities for limited time, expertise and finance; and the limits of what could be achieved given the need for changes to medical professional practices and given developing technologies. 11. The chronology follows on from where Dr Boyd‟s chronology ends; in April 1989. 12. The information in the chronology and the sections of my evidence which follow it, are drawn from my personal knowledge of events, from extensive searches of the Ministry‟s files, and from discussions with past and present Department/Ministry staff members who were directly associated with the NCSP. Despite best efforts there are issues on which the information is not always complete. 1989 The National Cervical Screening Implementation Unit 13. Following the recommendations of the Cartwright Inquiry in August 1988, the Minister of Health, Hon David Caygill made a commitment to establish a national cervical screening programme as soon as possible. In April 1989 the Department of Health established a National Cervical Screening Implementation Unit and initiated a project to develop a nation wide population-based cervical screening programme. In the budget speech in July 1989, Hon. David Caygill, by then the Minister of Finance, announced that the 5 Government was making available $14 million in 1989 and $12 million in subsequent years to implement a national cervical cancer screening programme. 14. In September 1989, responding to widespread concerns that the progress on implementation was unsatisfactory, the Minister of Health, Hon Helen Clark, appointed a Ministerial Review Committee on the implementation of the National Cervical Screening Programme. The 1989 Ministerial Review 15. The Ministerial Review Committee met three times. It comprises: Sandra Coney Fertility Action, Auckland Women‟s Health Council, other consumer groups David Cook Royal New Zealand College of General Practitioners Brian Cox Department of Social and Preventive Medicine, Otago Gillian Durham Project Leader, National Cervical Screening Implementation Unit Maree Leonard Programme Co-ordinator, Marlborough Area Health Board Betsy Marshall Cancer Society 6 Robin McKinlay Ministry of Women‟s Affairs Neil Prentice New Zealand Medical Association Heather Simpson Chairperson Clint Teague Pathologist, Wellington Wairete Walters Maori Women‟s Welfare League, Auckland. 16. The Ministerial Review reported in November 1989. I produce a copy of its Report as JMG/MOH/0001. The Review considered that many of the concerns and problems had arisen from poor communication between the Department of Health and Area Health Boards, community groups and providers. It stressed the need for improved communication, information and community involvement. 17. The Ministerial Review made recommendations on a wide range of issues. Some of the key recommendations were that: 17.1. the objective of the Programme should be to reduce mortality through increasing the numbers of women following a successful smear taking programme; 17.2. the previous focus on encouraging all eligible women to enrol to build up a national population-based register, should be replaced by a focus encouraging women to have smears and developing a cytology register (i.e. one on which smear results were recorded as they were taken); 7 17.3. participation in the Register should be marketed as routine, and women not wanting to participate should have to actively opt out of the programme; 17.4. urgent attention should be given to extending the cytology register to include histology information, to enable an assessment of the overall effectiveness of the programme to be conducted, and to provide a means of assessing the quality and uniformity of smear reading across the country; 17.5. education programmes should be developed for smear-takers and the existing standards for competence for smear takers should be redrafted; 17.6. a set of guidelines for minimum standards of competency for laboratories and cytologists should be developed and decisions taken so that a training course for cytology laboratory assistants could occur in 1990; 17.7. a National Co-ordinator should be appointed within the Department of Health; 17.8. Area Health Boards should incrementally join the Programme when they were ready rather than aiming at a common launch date; and 17.9. an Expert Group should be appointed to oversee the implementation of the Programme and to advise the Minister on policy matters and modifications to the programme. 8 18. The Ministerial Review Committee emphasised the need for strong national co-ordination, Maori co-ordination, and wide consultation with women and providers. The overall effectiveness of the Programme was seen to be dependent on its acceptability to women and their understanding of the Programme‟s objectives. 19. I observe at this stage that all the above recommendations were implemented, albeit some not as rapidly as many would have liked. For example, the reference in 17.4 above to “extending the cytology register to include histology information” needs to be seen in context. At this time (late 1989) there was no “cytology register”. The NCSP was still about 14 months away from having 14 separate Registers operating in the 14 Area Health Board regions. There was much to be done and the early priorities were to encourage and facilitate women to have smears, to ensure smear takers took smears correctly and at appropriate intervals, to encourage smear takers to promote the NCSP, and to report the necessary information to the laboratories. It was then necessary for laboratories to have sufficient staff to competently process the smear slides. Laboratories had to then report information in a consistent form to the Register. 20. The Register (or the 14 Registers) had to be set up. The focus at the beginning was on cytology results only. The Expert Group 21. The Expert Group recommended by the Ministerial Review Committee was established to advise the Minister and Department of Health on the development of policy and establishment issues. It met monthly between December 1989 and February 1991. Its terms of 9 reference are listed in the Appendix. No agendas or minutes have been located on Department files. 22. The inaugural meeting was held on 8 December 1989. From mid 1990 the Expert Group was chaired by Peggy G Koopman Boyden and comprised 14 members, including a wide representation from consumer groups, Maori and health professional organisations. It included representatives from the Public Health Association, the New Zealand Nurses Association, the Cancer Society, the Auckland Women‟s Health Council, Pasifika, Maori Women‟s Welfare League, the Royal New Zealand College of General Practitioners, and the Royal New Zealand College of Obstetricians and Gynaecologists. 1990 The National Cervical Screening Programme (NCSP) develops 23. The first National Co-ordinator, Gillian Grew, took up her appointment in the Department of Health on 5 June 1990. The description of her position included responsibility for the effective management and co-ordination of NCSP, implementing national policy on cervical screening, working closely with the Expert Group, and establishing close working relationships with Programme managers in area health boards. I produce a copy of a memorandum to the Minister of Health setting out the job descriptions of the National Co-ordinator and Area Health Board Programme Manager as JMG/MOH/0002. 24. The National Co-ordination Unit was in the Women, Child and Adolescent Health Policy section of the Department of Health. The 10 unit was led by the National Co-ordinator and comprised a small team of analyst/advisors plus consultants working on the Register and Help Desk. 25. Nationally, health education resources were produced by the Department‟s Health Education Unit. See for example, a Department of Health publication in 1990 Promoting Cervical Screening - Information for Health Workers, a copy of which I produce as JMG/MOH/0003. These resources included videos, pamphlets and posters and had a strong emphasis on wellness and an holistic approach to women‟s health. Another example is the 1990 Cervical Screening Kit. This is a collection of material including printed material, an anatomical model, and a sample of a cytobrush. It can be made available to the Inquiry if it is of interest. Local health promotion was often face-to-face education with groups of women, supplemented with some locally produced radio advertisements, pamphlets, posters and other materials. 26. As I have said, the NCSP was intended to operate from 14 Area Health Board sites around the country, with local Programme managers and Register staff. The Programme managers‟ responsibilities included developing the Programme in Board areas, and overseeing the implementation and operation of a computer- based register [see JMG/MOH/0002]. By August 1990, all Area Health Boards had Screening Managers in place and in many boards considerable planning and community consultation had already taken place. By late 1990 the contract for the purchase of the NCSP computer equipment was finalised and by the end of 1991 each of the 14 sites also had its own stand-alone register. This is referred to further in Part III of my evidence, which focuses on the Register. 11 27. While the National Co-ordinator and local Programme Managers met and communicated regularly, there was no formal line of accountability between the roles. The Area Health Boards (generally through the local Programme Managers) reported formally each quarter to the Department of Health, and informally through meetings and phone calls. This is referred to further in Part IV of my evidence, which focuses on monitoring. 28. There was considerable variability across the 14 sites in relation to the way the NCSP was implemented. This was consistent with the Government policy of the time of decentralisation and devolution of responsibilities to Area Health Boards, but it did complicate the implementation of a nationally co-ordinated programme. Expert Group Inquiries and Reports 29. During 1990 the Expert Group commissioned a national survey of screening coverage (i.e. how many women had had smears and how frequently), the development of training guidelines and standards of competency for smear takers, and research to inform policy development including a review of overseas screening programmes. Maori members of the Expert Group also identified issues for Maori women and reported on how to meet the needs of Maori women. (Further information on Maori women‟s involvement in the NCSP will be given by Ria Earp, Deputy Director-General, Maori Health). 30. In July 1990, the Expert Group received a report from Judith Straton, Senior Lecturer in Social and Preventative Medicine at the University of Western Australia, who had been invited to conduct an external review of the NCSP. I produce a copy of her report entitled 12 Review of the National Cervical Screening Programme in New Zealand as JMG/MOH/0004. 31. The brief for the review was: 31.1. to provide information on the experiences of other countries in implementing a cervical screening programme; 31.2. to provide information from overseas programmes on programmes for indigenous women; 31.3. to advise and comment on the NCSP, and options and changes being considered; and 31.4. to visit selected sites to provide a context for comment. 32. The Straton report included specific sections and recommendations on the following: 32.1. the National Cervical Screening Register; 32.2. reaching the target population; 32.3. services for taking cervical smears; 32.4. laboratory services for reading and reporting on cervical smears; 32.5. management of women with abnormal smears; 32.6. organisational structure and decision-making; and 32.7. evaluation, monitoring and research. 33. The Straton report identified weaknesses in the perceived focus of the NCSP on the development of the Register, the need to consider the role of traditional providers of cervical screening services, unrealistic deadlines and an underestimation of the complexity of developing and implementing a national programme. It generally provided confirmation of the policy direction for the NCSP; and 13 recommendations for future developments, drawing particularly on experience with the programme in Victoria, Australia. A strong theme was the need for the programme, which was imposed on and utilised existing medical and laboratory services, to build on the existing services. 34. In August 1990, the Expert Group reported to the Minister of Health. In the Foreword, the Expert Group reported that its task had been made difficult by the absence of a written policy. The report was therefore presented in the form of a policy statement. I produce a copy as document JMG/MOH/0005. 35. The Expert Group‟s report aimed to document and comment on the appropriateness of existing policy of the NCSP; make recommendations for future policy directions; and integrate the various elements of the NCSP into a unified package. The Foreword also stated that the Expert Group considered “that only with a nationally co-ordinated screening programme will cervical cancer be significantly reduced in New Zealand”. 36. In addition to the overall aim of reducing the incidence of morbidity and mortality of cervical cancer, the objectives of the NCSP were recorded as being: 36.1. by the year 1995, to increase to 80 percent or more the proportion of all women aged 20-64 years who have in the previous three years been screened for pre-invasive cancer and provided with appropriate follow-up diagnosis and therapeutic services; 14 36.2. by the year 1995, to reduce the death rate from cervical cancer in women aged 20 to 64 years by 20 percent or more in Maori and by 10 percent or more in Pakeha and Pacific Island women; and by the year 2000, to reduce the death rate by 50 percent or more in Maori and 25 percent or more in Pakeha and Pacific Island women; 36.3. by the year 2000, to reduce the incidence of invasive cervical cancer to fewer than 180 cases annually; and 36.4. by the year 1995, to increase to 45 percent or more the percentage of invasive cancer detected at stage 1 of the disease. 37. I note at this point that these targets altered as the NCSP developed. The targets in incidence and mortality have been, and continue to be, met. This is discussed further in Part IV of my evidence. 38. The Expert Group‟s Report also made comment on accountability and responsibilities. This included recommendations that the Programme should be co-ordinated on a national basis but operated regionally by Area Health Boards. The August Report closely followed the June appointment of the first National Co-ordinator. Area Health Boards were to work closely with providers in their areas, supporting and encouraging existing services so that women were invited and encouraged to take part in the national programme. 39. The establishment of a national register was seen as being a key tool in providing a management system for the NCSP. 15 40. The Expert Group also produced standards of competency for smear takers, and guidelines for training nurse, midwife and lay smear takers. 41. On 18 October 1990, Hon Helen Clark, Minister of Health, released a Ministerial Policy Statement on the cervical screening programme based on the advice of the Expert Group. I produce the memorandum to the Director-General of Health from the Minister attaching the policy statement and a press release, as JMG/MOH/0006. The press release included the announcement of funding for all Area Health Boards. It included the specific objectives identified in the Expert Group‟s Report, and added a further objective - to ensure 80 percent (screening and treatment) coverage for all sub-groups of the female population between 20 and 64 years. This related to the identification of three priority groups - mid-life and older women (35-64 years), Maori women and Pacific women. The policy statement also reinforced the need to build on existing services and to reduce short-interval re-screening. Change of Government: November 1990 42. Following the election of a National Government, the Department of Health reported to the new Associate Minister of Health responsible for the NCSP, Hon Katherine O‟Regan, in December 1990 on the history of funding for the Programme since 1989. A copy is produced as JMG/MOH/0007. The report indicated that hardware purchasing for the programme had been delayed, but that a legally binding contract for the purchase of equipment had been entered into prior to the election. 16 1991 Early implementation 43. On 28 January 1991 the Department of Health reported to the Associate Minister about the Expert Group. It reported that, as the NCSP‟s principal focus had moved to implementation, monitoring and evaluation, the Expert Group with its current membership and its executive role was not seen as appropriate for this stage in the NCSP‟s development. The Department recommended that the Expert Group be reconstituted into a new Advisory Group, comprising experts in the fields of epidemiology, cytology, AHB management, biostatistics and Mäori tanga. A new advisory committee (CSAC) was set up as a result. It is referred to again below. I produce a copy of the memorandum to the Associate Minister dated 28 January 1991 as JMG/MOH/0008. 44. In the same paper the Department reported that it was not in full agreement with the Expert Group report of August 1990 in relation to the smear benefit, Mäori and Pacific Island regional co-ordinators and certain funding matters. Nevertheless, the cervical screening unit within the Department had made substantial progress in carrying out planning and policy work based on the Expert Group‟s policy recommendations, and implementation was occurring at the AHB level. The Department therefore considered it was important for the new Government to endorse a national policy for the NCSP as this would provide a basis for the development of responsibilities, relationships and strategies. 45. The Associate Minister approved these recommendations and issued a press statement confirming the Government‟s policy and 17 announcing the establishment of a new cervical screening advisory committee to replace the Expert Group. I produce a copy of what is marked as a draft press release from the Office of the Associate Minister, dated 1 February 1991, as JMG/MOH/0009. 46. Another important input into cervical screening policy was the publication of a report from the Working Group which carried out the five-year review of the 1985 Skegg screening recommendations (see GRB/MOH/0007). These were clinical and technical recommendations relating to the NCSP. A copy of the published paper of the Working Group (Paul et al) is produced as JMG/MOH/0010. The 1991 recommendations essentially endorsed the 1985 recommendations but stated that by the time of the next review of the screening recommendations (a further five years) there should be sufficient information available to evaluate the success of the screening programme. The report also stressed the importance of developing a comprehensive cytology register linked to histology, and making improvements to the National Cancer Register. It also recommended a change to the age range, with the upper limit being moved from 64-69 years. I note that this recommendation was followed in the subsequent published policy. 47. The first marketing and advertising campaign also occurred in 1991. This campaign aimed to raise the acceptability of having a cervical smear - particularly the priority groups (older women, Mäori women and Pacific women). The campaign was co-ordinated nationally and included TV, radio, mail drops and letters. This campaign was supported locally by Programme managers. 48. The new advisory committee that replaced the Expert Group was the Cervical Screening Advisory Committee (CSAC). I produce a bundle of documents comprising the terms of reference (varied at 18 different times) and copies of relevant agenda items and all minutes available from Ministry files, as JMG/MOH/0011. The CSAC held its first meeting on 2 May 1991. At this meeting the CSAC discussed the background and implementation of the NCSP and agreed its terms of reference. The Appendix also lists membership and terms of reference. 49. The CSAC considered three reports in 1991. The first, called Final Steps for an Effective NCSP and dated 22 July 1991, addressed the necessity for routine transfer of cytology and histology information from laboratories to the Register, and the necessity of routine enrolment of women on the Register. I produce a copy as JMG/MOH/0012. The second, Outline of Areas of Evaluation for the NCSP dated 27 June 1991, discussed acceptability, accessibility and effectiveness of the NCSP as areas to be evaluated. A copy of this paper is produced as JMG/MOH/0013. It is discussed in more detail in Part IV of this evidence, on evaluation. The third report, NCSP Structural Approach to Monitoring and Evaluation dated 26 August 1991 stressed the importance of an appropriate (national) information system (the Register) to monitor the NCSP and to maximise its effectiveness. A copy is produced as JMG/MOH/0014. Revised Policy Statement for the NCSP: The 1991 Policy 50. In June 1991 the Associate Minister approved a revised policy for the NCSP set out in the document Government Policy for National Cervical Screening. I produce a copy of the 1991 policy (as reprinted in February 1993) as JMG/MOH/0015. It was based on the advice from the Expert Group and the recommendations of the Paul et al Working Group (JMG/MOH/0010). It also addressed 19 issues where the Ministry did not agree with the Expert Group‟s recommendations (funding, the smear takers‟ benefit and Mäori and Pacific co-ordinators). 51. It was intended that this document, together with the Cervical Screening Service Statement for Area Health Boards prepared by the Department, would provide the basis for the Department‟s contracts with Area Health Boards. A copy of the Service Statement is produced as JMG/MOH/0016. 52. In summary, the 1991 Policy Statement sets out: 52.1. standards for routine screening; 52.2. implementation of the register - transfer of information, recall and consent; 52.3. the establishment of appropriate standards and certification procedures for laboratories - standards for accreditation, volumes of smears read; and staffing; 52.4. education for the NCSP - health promotion; and 52.5. evaluation and monitoring - anticipated to happen at a later stage. 53. The Policy Statement retained the goal and objectives of the Expert Group‟s statement of August 1990, although the upper age limit of smear taking was increased from 65 to 69 in line with the 1991 Screening Recommendations of Paul et al. 54. The Policy Statement set the following standards for routine screening based on Paul et al: 20 54.1. all women between the ages of 20 and 69 years should be offered cervical screening every three years; 54.2. women should have a second smear within one year if they had never had a smear before or if more than five years had passed since their last smear; 54.3. routine screening after the first two negative smears should be repeated every three years; 54.4. women presenting with symptoms or signs suggestive of invasive cancer should be referred for gynaecological assessment irrespective of the smear result. The cervical smear may be unreliable as a diagnostic test where symptoms are present; 54.5. once a woman has been confirmed to have a high grade abnormality by histology, the appropriate follow-up would depend on the nature and treatment of the lesion concerned. This should include annual screening; and 54.6. more frequent than three-yearly screening was not recommended for women regarded at higher risk of cervical cancer. 55. The policy statement also set out the responsibilities of various agencies involved in the NCSP. It was seen as critical that everyone understood how their role fitted into a complex process and within a policy of devolved responsibilities. The policy was an attempt to be very clear about particular roles and responsibilities. 56. The main responsibilities of the Department of Health were to: 56.1. provide policy advice related to the NCSP; 56.2. implement aspects of NCSP policy which have national implications; 21 56.3. develop appropriate information and education strategies; 56.4. act on behalf of the Government in negotiating Area Health Board contracts related to cervical screening services; 56.5. provide advice and support to Area Health Boards; and 56.6. co-ordinate monitoring and evaluation of the NCSP. 57. The main responsibilities of the Area Health Boards were to: 57.1. ensure the delivery of cervical screening services; 57.2. liaise with general practitioners and other health providers; 57.3. implement a cervical screening programme consistent with the NCSP policy; 57.4. ensure appropriate targeting of services; 57.5. ensure that the standards of competency for general practitioners and other health providers were met; 57.6. ensure that there were adequate diagnostic and treatment services in the region to meet the needs of the NCSP; 57.7. monitor and evaluate the Programme in the board's area; 57.8. maintain the cytology register; and 57.9. provide data to the NCSP for national evaluation. 58. The main responsibilities of the general practitioners and other health providers were to: 58.1. deliver cervical screening services; 58.2. encourage women to enrol on the National Cervical Screening Register; and 58.3. implement the policy relating to the NCSP. 22 1992 Planning for the proposed health sector reforms 59. The health reforms announced by Hon Simon Upton in June 1991 proposed the separation of the purchasers of health services (both public and personal) from the providers of services. From July 1993 four Regional Health Authorities (RHAs), would be established as health services purchasers. The 14 Area Health Boards would be replaced by 23 Crown Health Enterprises (CHEs) which would be service providers. In addition, a new Public Health Commission (PHC) would be established. The Department of Health was to become a Ministry focused on policy advice and other central agency functions. 60. These proposed new structures would have significant implications for the NCSP as a national programme with local implementation in 14 sites. In addition, it was unclear what the responsibilities of the Ministry, PHC, RHAs and CHEs for the NCSP would be. This led to significant debate during 1992 and 1993 on how the NCSP would be managed within the new health sector structures. 61. Concerns focused on the risk of possible fragmentation; the difficulty of retaining the central or national office for planning, co-ordination, monitoring and evaluation; the separation of funding for personal and public health services; future management of Register; and ensuring the NCSP could continue to operate within the reform principles of the separation of purchasing and provision. 23 62. Throughout 1992 various submissions were prepared and meetings held regarding where and how the NCSP might fit in the reformed health sector. These included: 62.1. a submission by CSAC to the PHC Implementation Unit in February 1992, a copy of which is produced as JMG/MOH/0017; 62.2. a discussion document produced by CSAC dated 18 August 1992, a copy of which is produced as JMG/MOH/0018; 62.3. meetings with key stakeholders convened between representatives and the Department of Health between November 1992 and January 1993. I produce copies of the minutes of the meeting of agencies with an interest in the NCSP under the reformed health sector on 10 December 1992, a Background Paper for that meeting, and minutes of a meeting of a Working Group dated 13 January 1993, as JMG/MOH/0019 to 0021. 62.4. The roles and responsibilities in relation to the delivery of the NCSP set out in the 1991 Government Policy for Cervical Screening were eventually revised to take into account the reforms. This is referred to later in the chronology. 63. Other significant NCSP events in 1992 included: 63.1. The publication of a revised protocol for the management of abnormal smears, developed by an expert group commissioned by the Department and Cancer Society to review the earlier 1989 protocol. A copy of the Protocol 24 entitled Abnormal Cervical Smears - National Consensus on a Treatment Protocol for Management (June 1992) is produced as JMG/MOH/0022. 63.2. The revised Bethesda coding standard for the reporting of smear results to the Register by laboratories. This is discussed in Dr Boyd‟s evidence. 63.3. The appointment of the Interim Kaitiaki Group, discussed in the evidence of Ria Earp. 64. In July 1992, the first National Co-ordinator, Gillian Grew, resigned from her position. Although the position was advertised and two sets of interviews held, it remained vacant until January 1993 when Sue Dahl was seconded to the position for 18 months. 65. During 1992 preparations were also under way to change enrolment from an opt-on process, where the woman chose to enrol into the Register, to an “opt-off” process. This change required her to choose NOT to have her results and personal information entered on the register. The change required legislation. 1993 Proposal to reconfigure the Register 66. In January 1993, the Department commissioned computer consultants Azimuth Systems Limited to identify histology requirements for the Register. This contract was completed and reported on April 1993. A copy of the report is produced as JMG/MOH/0023. 25 67. Since the inception of the NCSP various advisory groups had recommended that there be one central register rather than the 14 separate sites. In February 1993, the Department received Ministerial approval to release a discussion paper on reconfiguration options for the Register. Consultation was completed by April, and Ministerial approval in principle granted in June for the Register to be reconfigured as a National Register with remote access pending costing and implementation planning. Final Ministerial approval was given on 12 January 1994. I produce a memorandum to the Minister dated 23 December 1993 as JMG/MOH/0024. Further detail is given in the section of my evidence on the Register. Early monitoring of the NCSP 68. A report reviewing laboratory services providing cytology services for the NCSP by V. Norton was circulated for comments in this year then released by the Department of Health in June 1993. This is referred to by Dr Boyd. A copy is produced as JMG/MOH/0025. 69. The First Statistical Report of the National Cervical Screening Programme was also released in 1993. It provided an analysis of data on the Register up to 18 August 1992. A copy is produced as JMG/MOH/0026. Statistical reports are discussed in the sections on the Register and on monitoring. The 1993 legislative changes 70. On 1 July 1993 the two main statutes that brought into effect the health reforms, the Health and Disability Services Act 1993 and the Health Reforms (Transitional Provisions) Act 1993, came into force. 26 There were other legislative enactments that were introduced in parallel with those main pieces of legislation. The Health Amendment Act 1993 was one of these, and it inserted a new section 74A into the Health Act 1956. Section 74A dealt with the National Cervical Screening Register (NCSR) and provisions for women to opt-off the Register, laboratory reporting requirements to the Register (including histology), and restrictions relating to disclosure of information on the Register. 71. Section 74A anticipated that a woman‟s cervical smear and histological information would be recorded on the Register unless the woman made a conscious choice to “„opt-off” (see also Register section of evidence). To achieve this end, section 74A required persons who took specimens for the purposes of cervical smear tests (cytology and histology) to ensure that the woman was informed that, unless she objected, a report on the test would be included on the Register. If she objected, the specimen taker was to ensure that a written acknowledgement of the objection was given to her and a written notice of the objection accompanied the specimen when sent to the smear reader. 72. Persons in charge of laboratories where specimens were read (i.e. analysed) were obliged to send a report on the specimen for inclusion on the Register, unless an objection had been notified. A woman could ask that her information be removed from the Register at any time. 73. Section 74A also restricted disclosure of information on the Register that identifies a woman except in the following circumstances: 27 73.1. if the woman consented to disclosure (necessitating that the Register staff contact the person); 73.2. if it was to the woman's medical practitioner for diagnosis or treatment, or to determine when the next smear was due; 73.3. if it was to enable positive results from a smear to be followed up; 73.4. if it was to enable smear reminder notices to be sent; and 73.5. if it was to give access for persons studying cancer or compiling and publishing statistics that did not enable identification of the women, but subject to any regulations made in relation to that access. 74. Section 74A remains in force today. 75. A second national marketing campaign occurred between June and September 1993 to coincide with the legislative changes to the Register. The campaign was nationally co-ordinated and supported locally, utilising media in a similar way to the 1991 campaign. This marketing campaign focused on encouraging women to enrol on the Register. 76. At or around the same time the Ministry of Health, in recognition of the special status of Mäori women, formally welcomed a kuia to the Ministry and the NCSP. Her role was to support and advise the National Co-ordinator. The 1993 NCSP Policy 77. In October 1993 the Associate Minister of Health approved an updated version of the 1991 Government Policy for National Cervical Screening to reflect the structural changes in the health 28 sector, the changes to the NCSP and NCSR introduced in the Health Amendment Act 1993, and the establishment of the Interim Kaitiaki Group to protect Mäori data. I produce a copy as JMG/MOH/0027. 78. The goals, objectives, targets, and standards of the updated policy remained the same as for the 1991 policy document. The 1993 policy included sections on the Register, laboratories, colposcopy and treatment services, health promotion, and evaluation and monitoring. These are covered in other sections of the Ministry‟s evidence. 79. The policy statement also set out the responsibilities of different agencies within the reformed health sector. 80. The main responsibilities of the new Ministry of Health were to: 80.1. provide policy advice related to the NCSP; 80.2. implement aspects of NCSP policy which had national implications; 80.3. provide advice to the PHC regarding the development of appropriate information and education strategies; 80.4. act on behalf of the Government in negotiating RHA and PHC funding agreements and contracts related to cervical screening services; 80.5. provide advice and support to local areas; 80.6. provide advice and support to the operation of the Register; and 80.7. co-ordinate monitoring and evaluation of the NCSP. 81. The main responsibilities of the RHAs were to: 29 81.1. ensure the purchase and delivery of cervical screening services within their regions; 81.2. purchase a cervical screening programme consistent with the NCSP policy; 81.3. ensure that there were adequate diagnostic and treatment services in the region to meet the needs of the NCSP; 81.4. monitor and evaluate the NCSP in the RHA region; 81.5. ensure the operation and maintenance of site registers in the RHA region; and 81.6. provide data to the NCSP for national evaluation. 82. The main responsibilities of the Public Health Commission were to: 82.1. monitor and analyse the state of the public health, including the incidence of cervical cancer in New Zealand and any risk factors; 82.2. provide the Minister of Health with policy advice in the area of cervical cancer; 82.3. purchase comprehensive cervical screening health promotion programmes that are consistent with the NCSP; 82.4. liaise with the National Cervical Screening Co-ordinator and RHAs to ensure that national and local co-ordination of the cervical screening programme was maintained; 82.5. focus the attention of individuals and communities on the significance of cervical cancer to health and the benefits of enrolling on the Register, and encourage community participation in these issues; 82.6. ensure appropriate health promotion programmes were provided for the priority groups (i.e. Mäori, Pacific, and older women); and 30 82.7. facilitate the development, production and distribution of accurate and appropriate health education materials consistent with agreed national guidelines in consultation with women, iwi and other Mäori groups, and appropriate agencies and organisations in the community. 83. The responsibilities of the Cervical Screening Advisory Committee (CSAC) and the Cytology Advisory Liaison Committee (CALC) remained in accordance with their respective terms of reference. 84. This updated policy document signalled that a more comprehensive review of the policy was to be completed by June 1994 to reflect policy work and reviews due to be completed in 1993. These included the KPMG review of the most appropriate placement of national co-ordination, decisions on reconfiguration of the Register, implementation of histology on the Register, the development of management processes for the protection of Mäori and Pacific peoples‟ data, and ongoing evaluation and monitoring. The roles of key agencies after the reforms 85. The Health and Disability Services Act 1993 broadly defined the roles of the key health sector agencies (i.e. the Ministry of Health, PHC, RHAs and CHEs). In considering the new structure the Cabinet Committee on Social Assistance Reform had noted that the NCSP was one of several small units which could be located outside the Department subsequent to the implementation of the health reforms. Dr Gillian Durham, later Chief Executive of the PHC, wrote to the Minister of Health on 10 March 1993 suggesting that the Cervical Screening Programme within the Ministry of Health should transfer to the PHC when it was established. This information is 31 cited in an internal Department of Health memorandum from Sonja Easterbrook-Smith to the Director-General dated 18 March 1993, a copy of which I produce as JMG/MOH/0028. 86. The Director-General of Health decided to commission a review of the future location of the co-ordination of the NCSP. This was initially to have been undertaken in June 1993 but was deferred until September. It was undertaken by a KPMG consultant and overseen by a steering group representing the Ministry of Health, PHC and the State Services Commission. The terms of reference are referred to in a letter from the Acting Director-General to the Chief Executive of the PHC dated 2 September 1993. I produce a copy as JMG/MOH/0029. 87. The terms of reference for the review included consideration of: 87.1. the roles and functions involved in national co-ordination, including the functions of the National Co-ordinator and the Register; 87.2. the roles of key agencies in the reformed health sector; 87.3. the means of ensuring the effective operation of the NCSP and for maintaining its integrity; 87.4. the WHO criteria for a successful population-based screening programme; and 87.5. the specific objectives and philosophy of the national cervical screening policy. 88. KPMG reported in November 1993. A copy is produced as JMG/MOH/0030. 32 89. The report recommended, among other things, that the Ministry of Health retain responsibility for providing co-ordination functions. It also recommended that the Register remain an integral part of the national co-ordination functions, with protocols to enable the Ministry, PHC and RHAs to access aggregated national data for the purpose of improving the purchase of appropriate health services, and for monitoring and analysis of public health. 90. The KPMG review also suggested that matters be reassessed again before the beginning of 1996, by which time the respective roles of agencies in the reformed health sector would be more fully established and major projects of the NCSP (such as the opt-off register, inclusion of histology data and the reconfiguration into a National Register) were expected to have been completed. 1994 PHC advice and consultation on revised NCSP policy 91. In March 1994 the PHC‟s advice to the Minister on cervical cancer (1993/94) was published. This advice recommended new outcome targets for screening. The recommendations included options for putting the NCSP in a holistic framework as part of a broader “well women” approach; that the PHC assess health promotion strategies for primary prevention of HPV (human papillomavirus) infection; that national co-ordination for the NCSP be maintained; and that RHAs should purchase services that maintained ongoing monitoring and evaluation of the laboratories‟ performance to ensure the accuracy of screening and diagnosis of abnormal cytology. A copy of the PHC advice is produced as JMG/MOH/0031. 33 92. In May 1994 the Ministry of Health initiated the comprehensive review of the national policy for cervical screening signalled when the Government‟s policy was updated in 1993. The review was to be done in collaboration with the PHC, and involved a steering group and stakeholder consultation. The 1993 policy document, the PHC advice to the Minister on cervical cancer, and a list of questions focusing attention on parts of the policy statement requiring attention and comment were circulated to a wide range of groups for comment. I produce a copy of a letter from the National Co- ordinator to listed organisations dated 9 May 1994 as JMG/MOH/0032. Although responses were requested by 20 June 1994 and further meetings of the steering group occurred later in the year, the revised policy document was not approved by the Minister and released until August 1996. Review of advisory committees 93. In late March 1994 the Director-General of Health requested that all advisory committees serviced by the Ministry be reviewed. This included the CSAC and CALC, which were both meeting regularly at the time. 94. The resulting review report from the National Co-ordinator dated 8 August 1994 noted that, as the NCSP was in its implementation stage, specific technical and professional advice would be still required on an ongoing basis for two years. A copy of the report is produced as JMG/MOH/0033. 95. This report recommended that the CSAC‟s terms of reference should be broadened as the initial Terms of Reference did not reflect the role the committee had performed nor the advice that had been required 34 in relation to legislative and health sector changes (see Appendix). The meeting frequency was recommended to change from quarterly to biannually, membership to be augmented to provide Maori, Pacific and consumer representation, and tenure to be extended through to 30 June 1996. These recommendations were agreed by the Director-General. 96. On 30 August 1994 the Associate Minister of Health agreed that the CSAC should continue as a Ministerial advisory committee until 30 June 1996, and to the amendments to the terms of reference and membership. A copy of the memorandum to the Associate Minister dated 25 August is produced as JMG/MOH/0034. 97. Terms of reference for the CSLAC were also developed (see Appendix). At this time the Ministry was working with the CALC/CSLAC in relation to requirements for histology, the transfer of cytology and histology to the Register, and the development of TELARC standards (discussed by Dr Boyd in his evidence on Quality Assurance). Other developments 98. In late April 1994 the Ministry hosted the first hui in Wellington for Mäori cervical screening co-ordinators from around the country. The hui reiterated two major concerns for Mäori women: the need for a national Mäori Co-ordinator and concerns over delays over the establishment of a permanent Kaitiaki group. 99. In November 1994, the first National Mäori Co-ordinator, Maria Rangiawha, was appointed. 35 100. A national Pacific Cervical Screening Conference was held in Auckland from 17-19 June 1994. This event brought together Pacific Islands screening workers and supporters as well as representatives of the Department and the PHC. 101. Another key development in late 1994 was the appointment of a Register Manager. The establishment of this position in the Department ended the role of outside consultants in the management of the Register. This is referred to further in the Register section of my evidence. 102. Sue Dahl resigned as National Co-ordinator in September 1994. She was replaced by Teenah Handiside, previously a policy analyst with the NCSP. 103. The CSAC presented its final report to the Associate Minister in November 1994. A copy is produced as JMG/MOH/0035. On 21 December 1994 the Associate Minister responded to the Chair of the CSAC on the recommendations presented to her in its final report. In response to recommendations that staff with expertise from several disciplines were required for the NCSP, the Minister commented that permanent staff now consisted of the two national co-ordinators, an analyst and assistant analyst, the Register co- ordinator, a programmer and a help desk person. In addition, there was formal access to a medical advisor. Copies of the letter from the Chair and the Associate Minister‟s response are produced as JMG/MOH/0036. 36 1995 General progress 104. As previously mentioned, the Minister of Health gave final approval to reconfigure the 14 Registers into one National Register in January 1994. Scoping for the work was carried out during 1994 and 1995 and the reconfiguration itself commenced in 1996. The section on the Register discusses this in detail. 105. A second hui, attended by about 50 Mäori smear takers, educators and co-ordinators, was held in February 1995. It focused on health education standards and resources. 106. A further Pacific people‟s conference was held in Christchurch. This conference recommended the formation of a group to develop guidelines for the training of Pacific cervical screening educators and a Pacific Data Management Group to develop guidelines to protect and release Pacific women‟s aggregated data on the Register. This is discussed further in the Register section of my evidence. 107. On 1 April the Health (Cervical Screening (Kaitiaki)) Regulations 1995 came into operation. They are still in force today. These regulations are intended to protect Mäori women‟s summary data stored on the NCSR. Application to, and permission of, the Kaitiaki Group is required before aggregated data on Mäori women can be disclosed or published. The protection of Mäori data was particularly significant to Mäori women. This is discussed in Ria Earp‟s evidence. 37 108. Shortly after the regulations came into force, the National Kaitiaki group was appointed to approve applications for the release of aggregate Mäori women‟s data. 109. In May 1995 the new CSAC and CSLAC committees met for the first time with their new membership and terms of reference (see Appendix). 110. On 1 July 1995 the PHC was reintegrated back into the Ministry of Health to form the Public Health Group. This once again bought responsibility for NSCP national functions together in the Ministry. The PHC‟s purchasing functions for the NCSP became the responsibility of RHAs. 111. In 1995 the CSLAC finalised standards for laboratories providing services to the NCSP. These standards were circulated to all laboratories. The standards are produced by Dr Boyd (GRB/MOH/0025) and discussed in the second part of his evidence. 112. In October 1995 the Ministry published the NCSP Second Statistical Report covering the analysis of data to 30 June 1994. A copy is produced as JMG/MOH/0037. This second report covered a limited time period due to the unavailability of data from the Auckland Programme after that date. While the Foreword of the report states that a Mäori Statistical Report had been prepared in conjunction with the second statistical report, this report was referred to the Kaitiaki group and was not finally released until 1999. 113. Also in 1995, the Ministry commissioned a working party to carry out the five-yearly review of the 1991 (technical) recommendations for Cervical Screening (Paul et al: JMG/MOH/0010). This 12- 38 member group, chaired by Professor Gillian Turner, met for the first time in November 1995, but did not finalise its review until 1997. 1996 Ministry review of accountabilities for the NCSP 114. In late March 1996 the Ministry reported to the Associate Minister on performance issues relating to the NCSP identified in the October- December 1995 quarterly performance reports of RHAs. I produce as JMG/MOH/0038 a copy of the Memorandum to the Associate Minister of Health dated 28 March 1996. 115. This memorandum reported on issues mainly relating to backlogs of enrolments in Canterbury and Auckland. 116. It also reported on the performance of the NCSP generally over that period. It indicated that: 116.1. the NCSP unit was relocated into the Prevention Policy section of the Ministry‟s Public Health Group in November 1995; 116.2. the National Co-ordinator Mäori had resigned; 116.3. the National Kaitiaki Group had been established; 116.4. CSAC had identified three areas of further work: monitoring and evaluation of the NCSP, recruitment and retention of women, and protocols for women who develop cervical cancer while on the programme; 116.5. a Pacific Data Management Group had been established; 116.6. the revised national policy was expected to be published by June 1996; 39 116.7. the timeframe for the first site to be added to the National Cervical Screening register was now April 1996. 117. The report to the Associate Minister also indicated that the Ministry considered that accountability arrangements were contributing to problems with the NCSP and that it planned to carry out a review. The review was carried out by a team of Ministry managers, which I convened. It reported on 11 April 1996, a copy of which I produce as JMG/MOH/0039. 118. The review team identified three key problems: 118.1. the close functional linkages between the operation of the Register and the policy staff working on the NCSP, together with the emphasis on provider issues as part of the national co- ordination function, had encouraged a focus on process and operational support to the detriment of policy review and the development of a monitoring framework; 118.2. accountabilities for the NCSP were confused between the Ministry and RHAs: it was likely that RHAs saw themselves as purchasing a series of individual components which contributed to a programme "owned" by the Ministry rather than purchasing as an integrated service for women; 118.3. current accountability arrangements limited the ability of RHAs to develop flexible purchasing arrangements that were best suited to local needs and that could be more consistent with the Government's principles for purchasing. 40 119. This review recommended the transfer of responsibility for national co-ordination to RHAs by the beginning of the 1997/98 financial year, after an assessment of whether co-ordination, consultation, provider support and liaison were needed at the national level. The Register, however, was recommended for retention in the Ministry. The review set out proposals for the respective accountabilities of the Ministry and RHAs. It also recommended that the CSAC not be reappointed and be replaced if necessary by technical expert groups. 120. On 15 April 1996 the General Management Team of the Ministry of Health accepted the recommendations of the review team and on 8 May the Associate Minister agreed to the proposals. A copy of the memorandum to the Minister of Health dated 7 May 1996 is produced as JMG/MOH/0040. 121. However, on 13 June 1996, following discussions with the CSAC (12 June) and NCSP Programme Managers (13 June), the Associate Minister withdrew her consent and confirmed that no change would be made to the accountabilities of the Ministry and RHAs in relation to the NCSP during the 1996/97 financial year. I produce a copy of a memorandum to the Associate Minister dated 13 June 1996 recording the new position as JMG/MOH/0041. Consideration of changes to accountabilities for the NCSP was to be included in the wider evaluation of the NCSP to be undertaken by the Ministry. 122. The Associate Minister noted that the main tasks for the Ministry in relation to the NCSP for 1996/97 were to: 122.1. provide support for Register local sites as the Register reconfiguration was completed; 41 122.2. develop systems for the management of the centralised database; 122.3. develop the Register as a resource for information for quality assurance; 122.4. provide information to purchasers and providers on the relative performance of providers, and data for the evaluation of the NCSP; 122.5. develop clear performance expectations for RHAs, based on the national policy and screening recommendations, to be implemented for the 1997/98 financial year; 122.6. begin the evaluation of the NCSP against its goals and objectives. 123. The Associate Minister subsequently informed the Director-General of Health of her intention to reappoint the CSAC with the committee being given the primary task of advising on the evaluation of the NCSP, which the Ministry intended to begin in March 1997. A copy of a letter from the Associate Minister of Health dated 5 August 1996 recording this is produced as JMG/MOH/0042. Changes to the role of National Co-ordinator 124. In late July 1996 Teenah Handiside, the National Co-ordinator, resigned. 125. The Ministry of Health reviewed the job description and competencies for the National Co-ordinator position. As part of this review the draft job description was circulated to interested parties for comment and the Ministry contracted with KPMG to consult key stakeholders in the NCSP to seek their views on the National Co- ordinator‟s role. I produce as JMG/MOH/0043 a copy of a fax sent 42 to the Central RHA dated 27 August 1996 as an example, and the supporting material put together by KPMG to accompany the job description. 126. The position was advertised in September, and Di Best, then NCSP Programme Manager for Otago, was appointed as National Co- ordinator in December 1996. The 1996 NCSP policy 127. The review of the national policy which began in 1994 was completed in mid 1996 and forwarded to the Associate Minister for approval and release. The Associate Minister approved the release of the policy, and on 24 August 1996 the Ministry of Health published the National Cervical Screening Programme Policy. This document is produced by Dr Boyd as GRB/MOH/0001. 128. The 1996 policy document provided greater detail on the operation of the NCSP than the 1993 policy (JMG/MOH/0027). It incorporated both the 1991 Cervical Screening Recommendations (JMG/MOH/0010) and The National Consensus on a Treatment Protocol for the Management of Abnormal Smears (JMG/MOH/0022), both of which were due to be reviewed again in 1996. Other issues 129. During 1996 new sites were added to the Register as the reconfiguration into one central register progressed. This is discussed further in the Register section of my evidence. 43 130. The National Kaitiaki Group continued to meet during 1996. The focus of their attention was on the preparation of the analysis of Mäori women‟s data to 31 December 1995. 131. The CSLAC held its final meeting on 19 June 1996. Discussion about the review of accountabilities, the release of the Standards for Laboratories, and the need for future technical advice for the NCSP were the main agenda items. The CSLAC‟s agenda and minutes are produced by Dr Boyd as GRB/MOH/0018. The Ministry arranged to seek further laboratory advice, as needed, from Dr Clint Teague. 132. The Associate Minister reappointed the CSAC under revised terms of reference with a primary focus on the planned evaluation. I produce a copy of a letter from the Associate Minister of Health to Dr Maree Leonard dated 24 September 1996 as JMG/MOH/0044. 133. Planning occurred for full evaluation of the Programme. A request for Proposals for the scoping report for the evaluation was issued in August 1996. The Ministry released the report in June 1997 and it was released to stakeholders for comment in September. Change of government 134. The general election in late 1996 resulted in the formation of the Coalition Government and the development of the National - New Zealand First Government Coalition Agreement. The Agreement signalled significant changes to the health sector and system: 134.1. the formation of one funding body to replace the four RHAs; 134.2. the replacement of CHEs with Hospitals and Health Services (HSS); 44 134.3. changes in the roles and responsibilities of the Ministry, the funder, and providers. 135. The formation of the Coalition Government also resulted in changes in Cabinet responsibilities, with the Hon Bill English taking over the Health portfolio. 1997 General progress 136. Reconfiguration of the Register into a single national database was completed with the integration of West Coast and Tairawhiti in February 1997. 137. Raina Meha was appointed as National Co-ordinator Mäori, Cervical Screening and Sexual and Reproductive Health. Among other tasks, she supported the National Kaitiaki Group. 138. During this period, the NCSP continued to work on laboratory issues supported the review of the Abnormal Protocol, and the completion of the review of the Cervical Screening Recommendations. 139. The new National Co-ordinator was also very proactive in establishing relationships with the new Transitional Health Authority, providers, programme managers, laboratories and other stakeholders. This involved liaison visits to laboratories, talking at conferences, NCSP site visits, and meetings with professional organisations. 45 140. Reappointments for the CSAC were finalised and the Committee reconvened after a year‟s break in July 1997. The Committee assisted the Ministry with advice on priorities for the evaluation of the NCSP. Coalition Government - changes to the health sector 141. On 30 May 1997, the steering group established to advise on the changes arising from the Government‟s Coalition Agreement produced its report for Government. A copy is produced as JMG/MOH/0045. The Steering Group recommended the separation of strategic policy to be carried out by the Ministry of Health from operational policy and other functions to be carried out by the then Transitional Health Authority (THA), later to become the Health Funding Authority (HFA). The report explicitly recommended that co-ordination of services be a funder function. 142. In late June 1997 the Ministry reported to the Minister of Health, the Hon Bill English, on issues associated with the consultation on the future location of national co-ordination for the NCSP. A copy of the Memorandum to the Minister is produced as JMG/MOH/0046. The Ministry advised that over the past year a number of positive developments had occurred within the NCSP. These included improvements in working relationships between the RHAs and the National Co-ordinator, the centralisation to one Register, the reduction of the Auckland Register data backlog, and improved liaison with private laboratories. 143. The Minister, the Hon Bill English, agreed to remove the specific obligation for consultation on the future location of national co- ordination for the NCSP to enable the transfer to be included with other transfers of functions to the HFA. 46 The planned evaluation of the NCSP 144. A draft scoping plan for the complete evaluation of the NCSP was developed in June 1997 for the Ministry by epidemiologists Brian Cox and Ann Richardson. A copy is produced as JMG/MOH/0047. It transpired that the costs of a complete evaluation well exceeded the funding available. 145. Extensive public consultation was undertaken on the evaluation plan to establish the priorities to be evaluated. Stakeholders consulted included health professionals, women‟s health lobby groups, women‟s organisations and cytopathologists. 146. The consultation was inconclusive. On the advice of the CSAC, and in keeping with best practice overseas, it was decided to concentrate on two aspects that would highlight safety and quality assurance. This is referred to again later in the chronology. 1998 Transfer of the NCSP to the HFA 147. In early 1998 the Ministry of Health reported to the Minister regarding the transfer of the NCSP from the Ministry to the HFA. A copy is produced as JMG/MOH/0048. The report recommended the abolition of the CSAC given that it advised the NCSP on technical/operational issues, which would become the responsibility of the HFA. The Minister agreed to this recommendation subject to the HFA receiving appropriate expert advice and subject to Mäori representation. 47 148. The announcement of the transfer of NCSP co-ordination functions and the Register to the HFA was made on 17 March 1998. In April 1998 responsibility for national co-ordination of the NCSP and the operation of the Register were transferred from the Ministry of Health to the HFA. 149. The CSAC met for the final time in June 1998. During the meeting the CSAC expressed concern about the lack of a Mäori Co-ordinator in the HFA structure and the effect this would have on data release. The Committee also expressed concern about the separate accountabilities for the NCSP and Register. The NCSP was managed by the Public Health Group in Auckland whilst the Register was the responsibility of the HFA‟s Information Management Group based in Wellington. Other publications 150. The review of the Recommendations for Cervical Screening was published in the New Zealand Medical Journal in March 1998. A copy is produced as JMG/MOH/0049. Although the Working Group suggested no major changes to the 1991 recommendations it did make recommendations about some minor modifications. The report also noted that the recommendations should be further reviewed within five years. 151. The Guidelines for the Management of Women with Abnormal Cervical Smears, produced by the Working Group reviewing the 1992 Abnormal Cervical Smear protocol, were published in September 1998. A copy is produced as JMG/MOH/0050. 48 152. The Statistical Report on Maori Women‟s data was finally published in 1999. It is produced by Ria Earp as LRE/MOH/0004. 153. The NCSP Third Statistical Report, analysing Register data to 31 December 1995, was published in June 1998. A copy is produced as JMG/MOH/0051. 1999 The misreading of cervical pathology in Gisborne 154. In late February 1999 the Ministry of Health‟s Policy Branch was contacted by a person working for Stuart Grieve QC, who requested details of quality control reports pertaining to laboratories. He indicated that the case for which the information was required involved a pathologist. The Ministry sent copies of NCSP statistical reports. The staff member was also advised to contact Dr Julia Peters, the HFA manager responsible for the NCSP, for further information. 155. On April 5 the Policy Branch received a letter from Mr Grieve QC outlining the court case and concern for other women affected. At about the same time, a medical officer from Tairawhiti Healthcare contacted the Director of Public Health in the Ministry‟s Safety and Regulation branch because of concerns arising from the court case. The Ministry contacted the HFA Personal Health section for more information and clarification. (As cervical cytology is a laboratory test, in the HFA it is the responsibility of the Personal Health Operating Group). It appeared that the HFA had only just become aware of the situation. 49 156. The Ministry and the HFA discussed what steps could be taken with regard to any other women affected. The Ministry maintained almost daily telephone contact with the HFA to discuss progress. The Ministry also contacted representatives of the Royal College of Pathologists of Australasia to discuss quality assurance. The former Minister of Health, the Hon Wyatt Creech, was first briefed formally on 22 April 1999. A copy of the Memorandum to the Minister is produced as JMG/MOH/0052. 157. The Ministry had a further meeting with the HFA on 28 April 1999 to discuss issues such as the NCSP in relation to the pathology issue, the use of the Register in contacting and tracing women, and whether the current evaluation of the NCSP could identify any similar deficiencies. Almost daily contact was maintained with the Public Health section of the HFA which had responsibility for the NCSP. 158. The Ministry reported further to the Minister on 3 May 1999, 20 May 1999, 21 May 1999, 27 May 1999, 9 June 1999 and 13 July 1999. These documents are produced as JMG/MOH/0053 to 0058. 159. At the time of first public awareness of the Gisborne situation the HFA was prevented by a court-imposed suppression order from taking any action that would identify Dr Bottrill. When the suppression order was lifted the HFA was able to undertake the notification of women and planning for retrospective pathology. It also established an 0800 advisory service, and appointed an independent advisory group to decide on priorities and strategies to limit damage for affected women. 50 160. On 21 September 1999 the then Minister of Health announced a Ministerial Inquiry to investigate the issues relating to the pathology reporting in Gisborne. 161. A draft paper outlining the background to cervical screening and the NCSP was prepared at short notice for the Inquiry team. A copy is produced as JMG/MOH/0059. A collection of “core documents” was also provided; a list of these is produced as JMG/MOH/0060. 162. A meeting was held on 3 November 1999 between members of the Inquiry and representatives of the Ministry and HFA. A copy of the minutes is produced as JMG/MOH/0061. NCSP evaluation progress 163. The Ministry of Health is currently managing the contract for the evaluation of the NCSP referred to earlier. The contract was won by Otago University with Dr Brian Cox as lead researcher. There are two areas of the screening programme that will be evaluated: 163.1. First, the adequacy and appropriateness of the data on the Register. This will involve the audit of screening histories of women who have developed cervical cancer. The audit will look at past slides and medical histories as well as interviewing women. The feasibility of re-reading slides will be assessed. As part of the audit the evaluation will also look at women who developed cancer but were not enrolled on the Register. 163.2. Secondly, the assessment of the appropriateness of follow up and treatment for women with abnormal smears. This will 51 also indicate the specificity of cervical screening in New Zealand, i.e. the ability of a screening test to correctly identify a person who is free of abnormality. 164. The evaluation will take two years to complete and cost approximately $400,000. The evaluation team anticipates that it will interview about 700 women. Both parts of the evaluation require extensive ethical approval. Current Ministry of Health responsibilities for the NCSP 165. The Ministry is currently responsible for strategic policy advice, Ministerial servicing and monitoring of the NCSP. Policy and Ministerial work and management of the NCSP evaluation are undertaken by the Policy Branch. The Performance Monitoring Branch is responsible for monitoring the HFA. The National Kaitiaki Group is serviced by the Safety and Regulation Branch. 52 PART II: THE PROGRAMME IN TAIRAWHITI 166. For the benefit of the Inquiry team, this section of the evidence begins by briefly noting the demography of the Tairawhiti region. The geographical, population, ethnic and socioeconomic profile are outlined along with relative rates of death from cervical cancer in the region. 167. The evidence then continues by discussing cervical screening in Tairawhiti before the NCSP, the establishment of the NCSP and the running of the NCSP in the region. Demography of the Gisborne region Geographical profile 168. The Gisborne region is generally defined as the area of the North Island of New Zealand extending along the northern section of the east coast from Hicks Bay on the north-eastern coastline west of East Cape, down to about the southern boundary of Gisborne District, and inland from the coast to the central ridge of the Raukumara and Huiarau Ranges (Discover New Zealand: A Wises guide, Auckland: Wises Publications Ltd, 1994). 169. For the purpose of the Gisborne Ministerial Inquiry, the boundaries of the Gisborne region are those of the health district boundary as drawn from the 1996 New Zealand Census. 53 [leave almost a full page for map - insert]. 54 170. The Gisborne region is also one of the most geographically isolated areas in the country. Both accessing services and means of communication within and outside the region are therefore a key concern to the people living in this area. This is particularly so for those communities lying in the more remote northern regions. 171. The geographical isolation, coupled with an economic downturn that began around 20 years ago, and national disasters such as Cyclone Bola, have significantly shaped Gisborne into what is today. Population profile 172. The population of the Gisborne region is 45,783. Of this total 19,386 are Mäori (NZ Census, 1996). Tangata whenua tribal groups are: Ngäti Porou, Rongowhakaata, Te Aitanga-a-Mahaki and Ngai Tamanuhiri. Ngäti Kahungunu are a significant neighbouring tribe (Health Status of the East Coast Regional Area, Gisborne: Gisborne Health Development Unit, 1987-88). Ethnicity of Gisborne women aged 20-69 years 173. The ethnicity of Gisborne women within the age target of the National Cervical Screening Programme varies throughout the region, but it is clear that there is a high number of Mäori women and that the largest concentration is in the far north of the region (refer to the Ethnicity of Female Population 20-69 Age Group Map. NZ Census, 1996). 55 Socioeconomic profile 174. The Gisborne region contains some of New Zealand‟s more disadvantaged communities. Poor housing and roads are a feature of this region, as is its high number of people who are unemployed and dependent on benefits for their income. A further feature of the region is its low ownership of telephones and cars, which is a reflection of the low socio-economic status of this region (Socio-economic Deprivation Map and Personal Resource Measures and Access Measures: Telephone and Vehicle Access within Households Map, NZ Census, 1996). Relative rate of deaths from cervical cancer in Tairawhiti 175. Tairawhiti area health board had the highest rates of death from cervical cancer of any area health board in the 20-64-year-old group for the period 1983-87. Rates for Tairawhiti were 12 deaths per 100 000 female population compared to 7 deaths per 100 000 for New Zealand (Mäori Women in the National Cervical Screening Programme: Analysis of Maori women’s data to 31 December 1995 (LRE/MOH/0004, p.13)). 176. As at 1986 New Zealand Mäori women had some of the highest incidence rates in the world, at over 32 incidences of cervical cancer per 100 000, compared to non-Mäori with 12 incidences of cervical cancer per 100 000 for 1986 (LRE/MOH/0004, p.14). 56 Cervical screening in Tairawhiti before the establishment of the NCSP 177. The following information is based on a report prepared (in November 1988) by Jane Smith, then a registrar in community medicine. It appears likely that she was the co-ordinator of the cervical screening programme in the region at that time. A copy of her report called „Cervical Screening Services Within the Tairawhiti Area Health District‟ is the first document of a bundle of documents relating to Tairawhiti. I produce these as JMG/MOH/0062. 178. In 1988 there were 22 GPs working in Gisborne city. In addition there were three GPs employed as special area doctors in the Tairawhiti area, providing services to Te Karaka, Waikohu County, Te Araroa (Waiapu) and Tolaga Bay (Northern Cook County). Special area doctors were employed directly by the Department of Health in remote areas. There were two obstetric and gynaecology specialists working both at Gisborne Hospital and in private practice. 179. At this time there were three hospitals in the Tairawhiti Area Health District: two in Gisborne (one public and one private) and a public hospital at Te Puia Springs. Gynaecology outpatient clinics were held at both public hospitals. In addition, a weekly family planning clinic and a fortnightly colposcopy clinic operated at Gisborne hospital. 180. Cervical smears were taken by medical practitioners in general practice, private or family planning clinics. House surgeons were encouraged to take smears where appropriate at hospital gynaecology outpatient clinics. Most doctors in the region used opportunistic screening on a two to three-yearly basis, with one-yearly screening for those identified as “high risk” or for those who requested it. 57 181. There were two colposcopes in Gisborne, operated by one of the gynaecologists. One colposcope was privately owned while the other was owned by the Gisborne Hospital. A colposcopy clinic was held at the hospital once a fortnight and patients were also examined in private practice. The waiting time for urgent colposcopy was two weeks and non-urgent patients were seen within three to four months. 182. There were two full-time pathologists operating from laboratories in Gisborne. Dr Bottrill was working at Gisborne Laboratories, a private community laboratory. The other pathologist had recently taken up an appointment at Gisborne Hospital after a vacancy had existed for over six months. 183. Approximately 5000 smears were passing through Gisborne Laboratories each year and 500 per year through the hospital laboratory. Dr Bottrill was reported as screening an average of 20 smears per day, and as considering that an increase of up to 30 per day would result in an unmanageable workload. The availability of part- time screeners would have solved that difficulty, but there was no-one available in Gisborne at that time. 184. A report by the visiting medical practitioner from the Department‟s Primary Health Care Programme noted Dr Jane Smith‟s view that cervical screening was going well on the East Coast, with all special area doctors providing a register and recalls on their computers. This was well in advance of Gisborne city GPs, who had a notable lack of any recall systems and only one or two computers (see GRB/MOH/0031). 58 185. In July 1989 Department of Health staff from the Cervical Screening Programme Implementation Unit visited the Tairawhiti area health board (AHB), GPs, the colposcopist and Dr Bottrill to discuss progress on cervical screening to date. The NCSP in Tairawhiti 186. The following information is summarised from documents from Ministry files, which are in the bundle of documents JMG/MOH/0062. By August 1989 a cervical screening committee had been formed by key AHB personnel, with the intention of adding a GP and consumer representation. Lianne Penny was appointed as cervical screening Programme Manager in May 1990. 187. Funding of $100,000 for the Tairawhiti AHB was announced on 18 October 1990 by the Hon Helen Clark. 188. When the NCSP began in Tairawhiti, extensive promotional activities were carried out. These included health education at high schools, promotions at doctors‟ surgeries, and through radio and shops. In addition, extensive educational activities were implemented at various clubs and community groups. Rural public nurses offered free screening days at marae-based clinics. Screening services were provided at the IHC after the success of education sessions. 189. Initially there was a Systems Administrator and a Health Educator working with the Programme Manager on the NCSP in Tairawhiti. Women‟s community-based clinics, workplace cervical screening services, rural health clinics and a women‟s health clinic were established. Suitcase screening clinics were available for use. 59 190. The local register began operating at the beginning of July 1991. Some GPs were enrolling all of their patients, others were only doing so if a woman asked. There was an awareness campaign with a radio campaign, local displays and press advertising. At this time the NCSP was only receiving 25 percent of the cytology referral forms which were going to the laboratories. Targets for enrolment of priority group women (Mäori, Pacific and older women) were set out at 2747 for year one; 5176 for year two and 7421 for year three. 191. In April 1991 the Tairawhiti Area Health Board Ethics Committee considered the local component of the NCSP. They considered that it was satisfactory, but expressed concern that they were being asked to endorse the NCSP when the decision had already been made at a national level. The Committee also felt that the NCSP was an inefficient use of funds and that there were more effective and efficient uses for the resources allocated within the Tairawhiti area, such as drug and alcohol abuse problems and child abuse. 192. The National Co-ordinator, Gillian Grew, responded that Tairawhiti had the largest percentage of deaths due to cervical cancer of any AHB, and provided information about cost-effectiveness and informed consent. 193. Against its 1991/92 contract the Tairawhiti AHB reported that compliance amongst GPs with enrolling women onto the Register was poor, and in the last quarter of 1991 approximately 50 percent of cervical cytology received by the laboratories was not being included on the Register. 60 194. The position of a Mäori Educator was established at the beginning of 1992 and proposals to fund community initiatives to offer education and information to Mäori and Pacific women were considered. 195. Information on the NCSP in Tairawhiti on the Ministry‟s files after this point comes from reports from the Programme Manager for the Tairawhiti Programme provided for quarterly Programme Managers‟ meetings with the National Cervical Screening Co-ordinator. During 1992 the staff working on the programme was reduced. The Programme Manager left and was not replaced. This meant that the Systems Administrator was carrying out both positions. The Health Educator position was also reduced to a 0.5 position. 196. In March 1993 the Programme Manager for Tairawhiti, Sharon Reid, reported that the rate of increase of enrolments had dropped and that education had increased. She also noted that she was placing emphasis on developing her business plan and budget and that the board had acknowledged that extra staff and support were needed. 197. In September 1993 the Programme Manager reported that there was only one person employed on the Tairawhiti cervical screening programme and as a result she was spending 80-85 percent of her time operating the Register. There was no replacement for the educator position and GPs were requesting information. It was noted that many things were not being done as the Programme Manager did not have the resources. 198. In September 1994 Sharon Reid reported that the site was now once again able to generate monthly and quarterly reports, and total enrolments were 7062 to 31 August 1994. The main focus was 61 education and getting information to the community. They were also looking for training opportunities for their Pacific educators. In her report for November 1994 she commented that they were getting positive reactions from smear takers‟ reports. In March 1995 she reported that very few women had chosen to opt-off, only one to two per month. The interface with the hospital laboratory was improving, and the Register had been able to accept the laboratory disk. 199. For the June meeting in 1995, she reported that that 8012 eligible women were enrolled to 14 June. Register processing tasks were progressing and they had begun training a half-time data entry operator in laboratory interfacing in April. Outreach clinics were beginning to pick up again, with the main focus being on recalls, and local service providers were looking at ways of encouraging women who did not respond. The hospital laboratory interface was progressing, but slowly. 200. In December 1995 she noted that the everyday work was being affected by internal restructuring in Tairawhiti Healthcare. The NCSP staff were covering health clinic reception duties but hoped to be back to doing just their own work by January 1996. A problem with generating letters had been fixed after a lot of help from the Ministry Register staff. 201. In March 1996 she reported the following enrolment rates to 23 February 1996 using 1991 Census data: 62 Age Percentage 20-24 84% 25-34 86% 35-44 83% 45-59 59% 60-64 37% 65 + 28% 201. The focus to the end of the financial year was to work out strategies specifically aimed at women 45 years and over. They were preparing for Waikato Medlab to take over Gisborne Laboratories (Dr Bottrill‟s laboratory). Much of the cytology and histology was to go to Tairawhiti Healthcare. This was an issue for them given the on- going problems with the electronic interface with the laboratory there, which was not expected to be up and running until March. 202. In June 1996 Sharon Reid reported that Medlab Waikato had taken over Gisborne Laboratories. They had received the first disk from the hospital laboratory and were negotiating over timeframes for further disks. Midland region Cervical Screening Co-ordinators had had quite a positive meeting with the Midland RHA. She had received data on Mäori women from the Kaititaki Group which had been very helpful in identifying gaps that the NCSP needed to address. 63 203. In December 1996 she reported enrolments as 10 202 eligible women, 75.5 percent of the 13 500 being used as the baseline by Tairawhiti, from 1991 Census statistics. There had been a big focus on cervical screening in September, as Midland had chosen this as cervical screening month. Promotional activities had included using sponsorship of touch rugby teams to link into screening in Well Women‟s clinics. At least one main promotional activity was planned for each month from February to June 1997. 204. In April 1997 she reported that the Tairawhiti Register site had been reconfigured in March and that they were slowly getting used to the changes. Evening Well Women‟s clinics were running fortnightly and were well attended. A $10.00 discount had been organised with GPs for smears to run from June to December. More non-medical smear takers were being identified and places sought for them to attend a smear takers course. In June 1997 Sharon Reid reported that the site had been working with the outpatients‟ department to attempt to reduce waiting times for colposcopy. She noted that they seemed to be getting more HGILs (high-grade invasive lesions), especially from their own clinics, but that they had not been able to evaluate this yet. Enrolment on the Register in Tairawhiti 205. The following table compares the Tairawhiti region‟s enrolment percentages with the national averages. 64 Year Tairawhiti National average percentage percentage 1991 14 7 1992 24 18 1993 27 33 1994 58 55 1995 64 69 1996 72 81 1997 85 83 1998 90 88 1999 95 91 206. We have not been able to locate any further references to Tairawhiti. 65 PART III: THE REGISTER Introduction 207. This section of evidence begins with a description of the National Cervical Screening Register (NCSR) as it is today. It is a record of all cytology and histology for women enrolled in the NCSP. The section then outlines the development of the Register. 208. Three significant changes that have occurred to the Register are discussed. Firstly, changing the Register in 1993 from an “opt-on” to an “opt-off” system; secondly, the reconfiguration of the Register from 14 stand-alone sites to one centrally located system with remote access, which was completed in February 1997; and thirdly, the incorporation of histology results onto the Register over the period 1993 to 1996. 209. The situation regarding Mäori and Pacific women‟s data is then outlined. There is also some information on the Cancer Register and its relationship with the Register. Description of the Register, and how information is obtained and held 210. The Register is an integral part of the NCSP. It is a system that complements and backs up smear takers‟ existing recall systems and registers. The Register consists of one centralised database located in Wellington at the HFA where it is operated under delegation from the Director-General of Health. This database has regional access from 14 local sites. 66 211. Two staff, a co-ordinator and a programmer, operate the central database. At the regional sites, in most centres there is a Register Co- ordinator who oversees data entry and quality assurance at the site level, and sometimes carries out other tasks related to the Register. The size of sites varies from Auckland with 17 staff, to the West Coast with one full-time equivalent. 212. When a smear has been taken, the smear taker prepares a slide and completes a laboratory referral form. This is either a laboratory specific form, an NCSP form, or an electronic form generated by a GP. If a woman chooses not to have a smear result sent to the Register (that is, she has opted off), a green sticker is attached to her form. The slide and the laboratory referral form are forwarded to the laboratory. In the case of a woman who has opted off, no information is sent to the Register. The electronic form has a field to indicate opt-off, or if it is printed as hard copy opt-off will be indicated in the usual way. 213. Laboratories send smear result information to their local Register site on floppy disk. This is done at regular time periods depending on variables such as how many smears the laboratory is receiving. All results are also sent to the appropriate smear taker. 214. The woman's NHI (National Health Index) number (when known), name and date of birth, date of the smear, the smear taker‟s ID and smear result using Bethesda coding are included in the information the laboratory sends to the Register. 215. The disk is loaded at the local site, checked for data integrity errors (invalid dates, missing fields, etc.) and stored in a temporary table. Incorrectly formatted information is returned to the laboratory and requested to be resent with errors corrected. Valid results are attached 67 to the woman‟s record and used to calculate her next recall date, and to initiate the tracking system if she is referred for treatment. 216. When a woman‟s first smear result is sent to the Register, personal information must be entered manually. The Register staff will query the NHI system (a separate health database) by using combinations of names and date of birth (DOB). A new NHI number will be allocated if there is no evidence to suggest the woman already has one. If there is any missing information, the Register staff will attempt to obtain this information from the smear taker or the woman herself. 217. Local sites send a letter to the woman when her first smear is recorded on the Register. This must be sent within five working days of receipt of a normal smear result and within 20 working days of receipt of an abnormal smear result, thereby giving the smear taker the opportunity to inform the woman (see GRB/MOH/0001, 1996 National Cervical Screening Programme Policy, p.21). This letter provides an opportunity to check the accuracy of personal details held on the Register. It includes the results of the smear test and gives the date the laboratory has recommended that the woman should have her next smear. This is the only communication a woman who has regular, normal smears will receive from the Register. 218. A letter is sent to a woman if the result is abnormal, unless she is already undergoing treatment. A nationally approved pamphlet explaining the meaning of the smear test result is sent to each woman whose smear result is not completely normal. Local sites also send a letter to women who are at least three months overdue for a cervical smear to remind them to have a smear (see GRB/MOH/0001, 1996 National Cervical Screening Programme Policy, p.22). 68 219. Women are “signed out” when they are referred for treatment to ensure that they are tracked and that they do not receive correspondence from the NCSP or appear on recall lists. The 1996 NSCP policy states that the local NCSP will follow up all women with a high-grade lesion for whom no smear or histology report has been received within four weeks, and all women with low-grade lesions for whom no smear or histology report has been received within six months. This means that women who are signed out for treatment are checked if their records show that no histology has been received. No histology result can mean that the result has not yet been forwarded by the laboratory, or it has been sent in hard copy for the Register still to process, or the woman did not attend the clinic. 220. Histology results are coded by the laboratory using SNOMED (Systematised NOmenclature of MEDicine) codes. These are sent to the Register and attached to the woman‟s record in the same way as cytology results. Not all histology results are received on disk. A considerable number are loaded manually at the Register national office in Wellington, as some laboratories do not have the computer program in place to be able to send the results on disk. 221. Data for both cytology and histology are stored by the laboratory for 10 years, either on computer systems or in hard copy. Some data may be archived. Many laboratories keep both data and specimens indefinitely. Where the data have not been reported to the Register it may be possible to obtain these data from the laboratories. 222. For the smear taker, the Register provides a report to back-up their own recall system informing them which women are overdue for smears; a six-monthly report regarding the quality of smears taken with a comparison to the national average; and a report alerting the 69 smear taker if there is no record of referral for a woman who has had an abnormal smear and/or is recommended for referral by the laboratory. The NCSP policy specifies that the NCSP will provide reports of the woman‟s previous smear history to assist laboratories with reading smears. 223. Twice each year, the NCSP also provides to laboratories an analysis of their own results in comparison to a national average. 224. Nationally, the Register provides data for analysis of enrolments, coverage and other statistical data. Development of the National Cervical Screening Register prior to reconfiguration in 1997 225. The development of the Register falls broadly into two stages: 225.1. the initial development of 14 stand-alone systems based on the 14 AHB areas; 225.2. the reconfiguration of these stand-alone registers into a national database. 226. This section describes the first stage, the development of the Register prior to reconfiguration. 227. From April 1989 the establishment of cytology registers was piloted in cervical screening programmes in the Marlborough and Wanganui area health boards. These pilot projects tested, among other things, the capacity of the software. I produce an evaluation of the Marlborough programme by J. Dowland dated October 1990 as JMG/MOH/0063. 70 228. The 1989 Ministerial Review (JMG/MOH/0001) made several significant recommendations related to the development of a Register: 228.1. the previous focus on encouraging all eligible women to enrol (to build up a population-based register) should be replaced by a focus on encouraging women to have smears and on developing a cytology register (i.e. one built up as smear results are recorded); 228.2. participation in the register should be marketed as routine, and women not wanting to participate should have to actively opt out of the NCSP; 228.3. urgent attention should be given to extending the cytology register to include histology information, to enable an assessment of the overall effectiveness of the NCSP to be conducted, and to provide a means of assessing the quality and uniformity of smear reading across the country. 229. By late 1990 the contract for the purchase of the NCSP computer equipment was finalised. Registers were installed in all 14 AHB regions between December 1990 and September 1991 and were all fully operational by early 1992. These computer systems were not linked electronically. All transfers of information between local sites prior to reconfiguration in 1997 were done by paper. This lack of a central system did create a problem and was very time consuming when women moved to a different region. The sites could not verify personal data electronically between them. Women who may have been enrolled in one region, re-enrolled in another region, leading to duplication in enrolments. 71 230. The setting up of the NCSP was “fast-tracked” in Canterbury with the intention of providing experience for other parts of the country. A copy of the evaluation by V. Norton dated June 1991 is produced as JMG/MOH/0064. 231. The 1991 Government Policy (JMG/MOH/0015) for National Cervical Screening identified the objectives of the register as to: 231.1. ensure women with abnormalities are identified and adequately treated; 231.2. provide information about past cervical smears to laboratories to assist them in interpreting smears and making recommendations on treatment; 231.3. provide information to general practitioners and other health providers so they can provide the most efficient and effective service to women; 231.4. make sure all women screened will be recalled at appropriate intervals, including women who have moved from one area health board region to another; 231.5. provide women with their own results; 231.6. monitor the quality of smears; 231.7. measure the population coverage achieved. 232. All 14 registers had common hardware and software purchased by the Department of Health. The hardware used for the development of the Register would be regarded as very basic if used today. However, at the time it was considered state of the art. The programmes for the software were written in the Ingres language which was considered to be technically a better product than its competitors at the time. As 72 computer technology changed, it became difficult to find competent programmers familiar with the Ingres language in New Zealand. 233. At the developmental stage, the hardware and software development was carried out by consultants and programmers contracted by the Department of Health. In 1994, NCSP positions were established within the Ministry and permanent staff were employed to manage the Register, provide help-desk facilities, and undertake programming or upgrades. 234. At most of the register sites, in addition to a Programme Manager, there was a Systems Administrator. These had limited technical ability but had a basic understanding of the system and were able to prepare back-ups and install upgrades. They worked closely with the Register developers, programmers and help-desk staff located in Wellington. 235. When an upgrade to the NCSP was needed it would be prepared in the Department and then sent on disk to each of the fourteen sites along with a plan and instructions. Upgrades were required, for example, when additional fields were added to the database or changes were made to the Bethesda codes. If the systems administrator had any problems installing the upgrade they would contact the help-desk person who would guide them through the process by telephone. Where substantial upgrades to software and hardware were required computers were sent to Wellington. 236. Laboratories were initially funded to cover the cost of sending their cytology results to the Register by floppy disk. There was on-going communication with laboratories by both local Programme Managers and the Department of Health relating to issues such as timeliness of 73 data transfer, use of Bethesda codes and other information technology problems. They received a small extra amount ($2.00) for processing and reading the smear to offset the cost of electronic compliance. Changing the Register from opt-on to opt-off (1993) 237. As mentioned previously, initially women had to opt-on to the Register; that is, they had to elect to be part of the NCSP and request to be enrolled on the Register. They also had to sign their consent on the laboratory request consenting to the use of aggregated data for statistical analysis. 238. Women, however, depended on their GP or other smear takers to inform them about the NCSP and Register. Smear takers who did not see participation in the programme as useful or a priority may not have offered women the choice to enrol. 239. The 1989 Ministerial Review Committee recommended that enrolment should be considered routine once a smear was taken, with a provision for women to opt-off if they wished (JMG/MOH/0001 Ministerial Review Report, p13). An opt-off register would require all smear data from the pathology laboratories to be sent to the Register unless a women actively chose to opt-off. 240. The 1990 Expert Group concurred with this view (JMG/MOH/0005 Expert Group Report, p.1). 241. Studies in New Zealand and overseas showed that an opt-on register was likely to recruit only 30-40 percent of women having a smear. With such low enrolments there was a risk that there would be too few 74 women enrolled on the Register for the NCSP to meet its objectives of increasing coverage and reducing mortality and incidence of cervical cancer. The opt-off option was supported as it would encourage greater participation in the programme, provide greater choice, provide greater ability to assure quality, result in less data fragmentation, allow the identification of targeting requirements and provide a better basis for policy development. 242. However, legislation was required to enable an opt-off register to be developed to allow, without risk of breach of confidence, private information to be forwarded to the Register by health professionals. 243. Informed consent was a significant issue in the post-Cartwright era. I understand that there was some concern that opt-off legislation might result in smear results for some women being sent to the Register without their informed consent because their smear taker had omitted to inform them of the NCSP. The contrary view was that women were safer if they were unknowingly enrolled in the NCSP than if they were never offered the opportunity to enrol, as was happening with the opt-on system. This safety-net aspect of the Register helped it gain support from the community, especially women‟s groups. In November 1991, following extensive consultation with women, the Associate Minister of Health endorsed the requirement for legislation to bring about an opt off register for the NCSP. 244. A paper from the Associate Minister to Cabinet dated 1 April 1992 proposed that the Register be altered to a voluntary opt-off system. The Cabinet Social and Family Policy Committee agreed on 28 April 75 1992. Copies of the memorandum to Cabinet and Cabinet Committee minute are produced as JMG/MOH/0065 and 0066. 245. Consequently, an amendment to the Health Act 1956 was passed in 1993 which required smear takers to inform women that, unless they objected, their test results would be forwarded to the Register, and obliged laboratories to forward a report of test results to the Register unless objection had been notified. 246. The increase in enrolments and therefore data to the Register was dramatic. Overnight 80-99 percent of all smear results from the various laboratories were being forwarded to the Register (as opposed to 20-40 percent prior to the introduction of the legislation). Enrolments rose to 55 percent of eligible women in 1994, 69 percent in 1995, and 81 percent in 1996. By the end of the calendar year in 1999 enrolments on the Register had risen to 91 percent with 84.6 percent having had a smear in the previous five years. This exceeded the projected targets set in the 1996 policy and compares well with cervical screening programmes internationally. Reconfiguration of the Register 247. Decisions were made early in the development of the NCSP programme that there would be 14 stand-alone register sites. Although the local site registers had common hardware and software, they were not linked electronically to each other in any way. 248. Having 14 stand-alone sites led to difficulties with tracking women who moved. This compromised the Register‟s recall functions. Any problems arising in any or all of the sites also created resource issues related to upgrades and help-desk provision. The increase in data to be 76 processed with the introduction of legislative changes in July 1993 stretched the capacity of local registers, personnel and resources. 249. In anticipation of this, in February 1993 the Associate Minister approved the release of a discussion paper dealing with the future configuration of NCSP registers. The paper presented four options. A copy of the memorandum to the Minister dated 5 February 1993 is produced as JMG/MOH/0067. 250. By April 1993 consultation over the options for the reconfiguration of NCSP registers was completed, with the majority of support being for a National Register with remote access. I produce a copy of a paper prepared for the Department of Health summarising the responses as JMG/MOH/0068. 251. In June 1993 the Associate Minister of Health approved selection of the option for a National Register with remote access from 14 sites subject to future consideration of costing and planned implementation. Final approval was given on 12 January 1994 (JMG/MOH/0024). 252. Scoping for the reconfiguration was undertaken towards the end of 1994 and preparatory work was carried out during 1995. Final approval to start the tenders for the equipment was given by the Ministry in late 1995. 253. Reconfiguration started in May 1996 and was completed in February 1997. As the Register was in use during the day, the system could be 77 taken down for reconfiguration only over the weekends. After careful checking, duplicate records set up for women at different sites were merged to give a single record of their screening history. 254. Since 1997 there has been one centralised stand-alone database with regional access from 14 sites. 255. The reconfiguration of the Register greatly increased its usefulness as a tool for the NCSP. Immediate access to a woman‟s screening data became possible, regardless of which site it had been sent to. This included the woman‟s smear results and histology history, where it was available on the Register. 256. Significantly, comparisons of smear taker and laboratory quality against national averages became possible. Previously, information on how their histology data compared against national data had been provided to laboratories once only - when data was extracted from the Register for the preparation of the second statistical report (which included data to 30 June 1994 (see GRB/MOH/0028 for the report sent to Dr Bottrill‟s laboratory). Comparisons of data of individual laboratory reporting patterns against national patterns is now supplied to laboratories biennally. Incorporation of histology on the Register 257. As noted previously, the Register initially only held cytology results. The lack of histology on the Register meant that it was not possible to correlate cytology with histology or to check that women with abnormal smears had attended for colposcopy or treatment. Matching histology to previous smear results provides a retrospective check on 78 the quality of smear reading, but only where women are enrolled on the Register. 258. The Ministerial Review Committee in 1989 (see JMG/MOH/0001) had recommended that urgent attention be given to considering whether there should be an extension to the Register to include histology results. It considered that mechanisms that linked cytology and histology were the best way of checking the quality of smear reading by laboratories. The Register sub-committee of the Expert Group in 1990 also noted the need for a histology register (see JMG/MOH/0005 Expert Group policy statement, p.198: 11.1.9). The 1990 Straton report concluded that histology information was required for several key functions of the Register, including the follow-up and monitoring of abnormalities (see JMG/MOH/0004). The CSAC, in its 1991 paper, noted the importance of the transfer of cytology and histology information to the register to "ensure women with abnormalities are identified and adequately treated" (see JMG/MOH/0012). However, the capability of the Register was at this time not sufficiently developed to accept histology information. 259. The Health Amendment Act 1993 made it compulsory for both a woman‟s cytology and histology results to be sent to the Register unless the woman had objected. It was anticipated that histology results would to be coded by laboratories using SNOMED codes, sent to the Register and attached to the woman‟s record in the same way as cytology results. 260. In September 1993 a draft document was prepared for the Ministry of Health by an Azimuth consultant and a technical committee of the CALC on the implementation of histology in the Register and quality assurance (see GRB/MOH/0020). It noted that once the Register had 79 been developed to accept histology results, the NSCP could be adapted to provide correlation reports for each participating laboratory at quarterly intervals which would cover the 12 months preceding the reporting date. Each laboratory could then receive national correlation results, histology correlation to the laboratory‟s cytology results and cytology correlation to their histology results. These reports could then be used for monitoring trends in the examination of cytology and histology results by TELARC and the Programme. 261. The CALC‟s minutes reveal that it discussed the Azimuth report and laboratory quality assurance generally at length at its meeting on 17 November 1993 (see Minutes of CALC meeting, 17 November 1993, in GRB/MOH/0018). It noted that data produced for quality assurance could easily be misused or misinterpreted and that the Committee was concerned that there was not an independent person in New Zealand with enough expertise to assess potential histology and cytology correlation problems. The CALC agreed that these statistics should be generated by the Register 12-monthly. If there was a discrepancy they would be generated six-monthly, where statistically significant. The CALC also noted a process for assessing problems should the NCSP discover a possible indication of inadequate laboratory performance, which, it agreed, should be sent to all laboratories for comment. 262. However, in practice it was not possible for the Register to accept histology results at this time. Upgrades had to be carried out at each site and by laboratories to enable the Registers to receive the histology data. This was time consuming and involved a considerable amount of programming. As a result, histology results were initially received by local sites in hard copy. 80 263. In addition, no new funding was provided to laboratories, which resulted in many not performing the upgrades to their computers necessary to send their histology data to the Register by disk. Even today, I understand that some laboratories still do not have the programs that allow electronic transfer of histology data and are still sending histology results in paper form to the Register for manual data entry. This substantially increases the amount of processing time on the form for the Register. Results received in hard copy need to be coded, because this is not included, then the data entered. The need to free up staff time and to provide funding for this to be done is the major reason for the delay in histology being available on the Register. 264. Until mid-1995 the Register lacked the technical capacity to link histology data linked to cytology data. This meant it was not possible to produce a record for an individual woman that allowed her cytology and histology data to be compared. Even then, this record would be complete only where the histology and cytology had been performed in the same area. It was not until the completion of the reconfiguration of the Register in March 1997 that a complete correlation of histology and cytology data was available, regardless of where these had been carried out. 265. Histology was routinely entered on receipt from mid-1996. Most of the backlog of histology data had been received by Register sites and entered by late 1996. There are still gaps in histology today where it has not been forwarded to the Register. 266. I understand that there has been an effort to ensure complete histology records for the Gisborne area. All histology that is available has now been entered onto the Register. This covers most histology since 1 July 1993. 81 Mäori women’s data 267. Evidence concerning the collection and use of Mäori women‟s data is given by my colleague Ria Earp, who is Deputy Director-General, Mäori Health at the Ministry. Pacific women’s data 268. In recognition of the particular cultural beliefs of Pacific women and the sensitive nature of cervical screening, an Interim Pacific Data Management Group was established in 1994 to protect and oversee the release of Pacific women‟s summary data from the Register. In 1997 the Pacific Women‟s Data Management Group was established to advise on the release of aggregated data from the NCSP. It meets as and when required to advise on data release. Cancer Registry 269. The Cancer Registry established under the Cancer Registry Act 1994 is held by the NZHIS (New Zealand Health Information Service), which is part of the Ministry of Health. It records the number of all new cases of cancer that occur. It has the potential to assist in the evaluation and monitoring of the NCSP by allowing the identification of individual women who develop invasive cervical cancer. Auditing the smear histories of women who develop cervical cancer is one method of evaluating a cervical screening programme. 82 270. The Cancer Registry is only a useful tool if it is accurate. Prior to 1994, the Cancer Registry was not supported by legislation. Given medical practitioners‟ concerns about the risk of breaching patient confidentiality, a high proportion of cases were not reported to the Registry. On 1 July 1994 the Cancer Registry Act and Regulations came into force making it a legal requirement to report all incidences of cancer to the Cancer Registry. 271. The registration of cervical cancer is derived either from a histology or cytology report from the laboratory or from a hospital event. 272. Accuracy and completeness of registrations for cancer has improved greatly in recent years. In 1999 there has been an effort to ensure that comprehensive reporting of in situ cancer is achieved and the Cancer Registry now probably accurately records occurrences. Recording of deaths due to cancer is obtained from the death certificates and accurately reflects occurrences. 273. The evaluation of the NCSP will draw on Cancer Registry data. This is discussed further in the next part of my evidence on evaluation and monitoring. 83 PART IV: MONITORING AND EVALUATION OF THE NCSP Introduction 274. This part of the evidence provides information on the monitoring and evaluation role of the Ministry of Health over the NCSP for the period 1990-1999. This is presented in five sections: 274.1. overview of the sector accountability arrangements; 274.2. formal monitoring of the NCSP; 274.3. operational monitoring of the NCSP; 274.4. evaluation; 274.5. health outcome targets for cervical screening. 275. While the terms “monitoring” and “evaluation” are often used interchangeably, I would like to differentiate them here. Monitoring is generally ongoing and routine and, in the health sector, particularly relates to performance against contracts. Evaluation is a process that attempts to identify, as systematically and objectively as possible, the relevance, effectiveness and impact of activities in the light of their objectives. Evaluation often uses information from monitoring. 276. Monitoring of the NCSP has been both through the formal inter- agency accountability arrangements of the health sector, and, more informally, at the operational level. Operational monitoring can be escalated to bring formal accountability arrangements into play when problems are not able to be resolved at the regional level. 277. For clarity I will refer to the RHAs, THA and HFA collectively as “the funder”, although prior to 1996 the term “purchaser” is more correct. 84 Overview of the sector accountability arrangements 278. The formal accountability arrangements cover three levels of performance monitoring: 278.1. the Purchase Agreement between the Department/Ministry and the Minister; 278.2. the contracts between the Minister and the area health boards (AHBs) to 1993, and subsequently Funding Agreements between the Minister and the funder; 278.3. contracts between the funder and providers such as Crown Health Enterprises (CHEs), later called Health and Hospital Services (HHS). These are monitored by the funder, and are covered in the HFA‟s evidence. 279. CHEs/HHSs are also monitored, in terms of the Government‟s ownership interest, by the Crown Company Monitoring and Advisory Unit of Treasury. This is not, however, discussed here. Ministry to Minister/Parliament 280. The Ministry‟s role in monitoring is outlined in the annual purchase agreement between the Minister of Health and the Chief Executive of the Ministry of Health, which describes key result areas and other expectations of the Minister. The Ministry‟s financial statements are audited annually by the Audit Office, as required by the Public Finance Act 1989. 85 281. The Ministry of Health is required to submit annual reports to the Minister of Health on the extent of the Ministry‟s achievement of the objectives of the Crown. These are subsequently tabled in Parliament and subject to review by the relevant select committee. AHB/funder to Department/Minister 282. From 1990 until prior to the introduction of the 1993 health reforms, the Department of Health was responsible for negotiating AHB contracts. The AHBs reported quarterly to the Department of Health on their performance against agreed output levels or targets. 283. Since 1993 the Ministry of Health has negotiated the Minister‟s annual Funding Agreement with the funder (including the PHC from 1993-96) and monitored performance against this on behalf of the Minister. This is provided for under the Health and Disability Services Act 1993. Health and disability support services are purchased by means of contracts, or purchase/service agreements with service providers. The performance of providers is monitored by the funder according to agreed contractual obligations. 284. The Funding Agreements specify performance measures for quantity, quality, cost and timeliness, and reporting requirements. Performance measures are renegotiated annually. Changes to Government requirements during the course of the year are dealt with by negotiated amendments to the Funding Agreement. The funder is required to provide a formal report each quarter to the Ministry on output performance against the Agreement. 285. Until April 1998, when national co-ordination was transferred to the HFA, the Ministry also had a significant role in the operational 86 monitoring of the NCSP. I will outline this later, as well as discussing the role played in monitoring by advisory committees. Formal monitoring of the NCSP Monitoring of area health boards by the Department of Health, 1990-93 286. The 14 regional sites of the NCSP were set up within the AHBs. Between 1990 and 1993 the Department of Health formally monitored the NCSP through specific quarterly reporting requirements in AHB contracts. This information was supplemented by discussion and correspondence with Programme Managers. 287. The AHB quarterly reports to the Department of Health informed on progress against service statements based on the 1991 Government Policy for Cervical Screening (see JMG/MOH/0015). The 1991 Service Statement had an objective for the NCSP to reduce in the next ten years, the incidence of cervical cancer by 70 percent and the number of deaths of New Zealand women from cervical cancer by 65 percent (see JMG/MOH/0016). Contract performance indicators reported on included: colposcopies per 1000 women; women waiting longer than six months for colposcopy; percentage of women on the NCSR who had had a smear in the last three years; and percentage of cervical cancer detected at Stage 1 of the disease. 87 Ministry of Health Monitoring of the Funder The 1993 policy statement 288. Following the health sector restructuring from July 1993, the 1991 Government policy for the NCSP was updated. The 1993 policy statement (JMG/MOH/0027) set out the responsibilities for monitoring and evaluation of cervical screening as follows: 288.1. the Ministry of Health was to co-ordinate monitoring and evaluation of the NCSP; 288.2. the RHAs were to monitor and evaluate the local programmes, and provide data to the NCSP for national evaluation; 288.3. the PHC was to monitor and analyse the state of the public health in New Zealand, including the incidence of cervical cancer in New Zealand and any risk factors; and 288.4. the CSAC was to advise on the monitoring and evaluation of the effectiveness and efficiency of the NCSP. 289. In relation to laboratories, the 1993 policy document carried forward the text from the original 1991 policy (changing the reference to the Department of Health to the Ministry of Health). 290. The text included the following: “4.1.2 All cytology laboratories servicing the NCSP should be registered with the Testing Laboratory Council of New Zealand (TELARC) or other recognised authority. It is expected that laboratories not so registered will apply and 88 gain such registration. A reasonable period of time will be allowed for the laboratories to obtain registration. 4.1.3 The Ministry of Health will be responsible for confirming that those laboratories carrying out cytology screening and histology for the NCSP meet the requirements set out in 4.1.4 4.1.4 The criteria for registration, by TELARC or other recognised authority will be established by the Cytology Advisory Liaison Committee in consultation with the Ministry of Health. The criteria will include: 18.104.22.168 reading of a minimum number of smears per year; 22.214.171.124 employment of adequate numbers of suitably qualified staff; 126.96.36.199 maximum workload for each cytoscreener; 188.8.131.52 adequate in-service education; 184.108.40.206 satisfactory participation in both external and internal quality assurance procedures; 220.127.116.11 provision of cytology reports to the cytology register.” 291. Paragraph 4.1.3 could be read as intending that the Ministry would in some way be responsible for confirming that laboratories were meeting all the criteria required for TELARC registration. This was clearly not possible, as the Ministry had no direct relationship or influence over laboratories after RHA contracts replaced the previous payment arrangements under Part II of the Social Security Act 1964. Ensuring that laboratories were registered by TELARC or another suitable quality assurance programme was seen as the way of ensuring that laboratories met quality standards. 292. In relation to the review of the 1993 policy document, the CALC commented that “the Ministry of Health does not have the expertise and nor would it seem an appropriate function of the Ministry of Health to confirm that laboratories were meeting detailed requirements related to TELARC accreditation.” The CALC 89 suggested that the intent would be met by deleting paragraph 4.1.3 and relying on paragraph 4.1.2, which dealt with registration. This would make it clear that the Ministry would be responsible for confirming that laboratories carrying out cytology screening and histology were accredited by TELARC or other registered authority. I produce the CALC submission on the Government Policy review, considered at the CALC‟s meeting of 29 June 1994 as JMG/MOH/0071. However, given the delays in the completion of the policy review, the wording in the 1993 Policy remained unchanged until the new Policy document was issued in June 1996. 293. The 1994/95 Funding Agreements with RHAs required each RHA to use reasonable endeavours to ensure that all laboratories providing laboratory services for cervical cytology and histology were registered with TELARC or an equivalent quality assurance programme. The Funding Agreements were the primary accountability documents for RHAs, setting out the requirements of the Minister as agreed with the RHA. I produce a bundle of relevant extracts from Funding Agreements from 1993/94 to 1996/97. The Agreements themselves are very substantial documents, copies of which can be made available if required. The bundle is JMG/MOH/0072. NCSP Requirements in Funding Agreements 294. For the 1993/94 year, services were essentially rolled over from AHBs. Each RHA was required to provide cervical screening services to which eligible women had access in 1992/93, including smear- taking services and laboratory diagnostic services, and maintenance and operation of the cervical screening register at regional sites. 90 295. For the 1994/95 year, RHAs were required to provide, in conjunction with each other, cervical screening services consistent with section 74A of the Health Act and the 1991 Government policy for National Cervical Screening. This included local management and co- ordination, functional relationships between local programmes and National Co-ordinators, health education and promotion for individuals and families, cervical smear-taking services, laboratory diagnostic services, colposcopy and treatment services, and maintenance of the Register. 296. In particular, each RHA was to use reasonable endeavours to ensure that, inter alia, all laboratories providing laboratory services for cervical cytology and histology transferred smear-test results to the Register by disk, and were registered with TELARC or an equivalent quality assurance programme. This was consistent with the policy on laboratories (see JMG/MOH/0015, 1991 Government Policy for National Cervical Screening, Section 4). 297. For the 1995/96 year the obligations were largely the same as for 1994/95, with the additional requirement for RHAs to purchase the NCSP and cervical screening services consistent with the Health (Cervical Screening Kaitiaki) Regulations 1995. 298. The obligations in the 1996/97 Funding Agreement included more explicit timeframe requirements for women with identified precancerous to invasive cancerous lesions to receive colposcopy. In relation to laboratories, RHAs were required to use reasonable endeavours to ensure that laboratories transferred cytology and histology test results - in the agreed codes and format - electronically to the Register, within prescribed timeframes of the test being taken 91 (10 working days for cytology and 20 working days for histology), and to provide non-identifiable data on the Register to the Ministry of Health when reasonably required by the Ministry. Service obligations for laboratory diagnostic services required results from cervical cytology to be made available to smear takers within five working days of the test. 299. The 1997/98 Funding Agreement signed with the THA reflected changes made to accountability arrangements as a result of Cabinet decisions on the Ministry‟s Review of RHA Accountability Mechanisms in 1996. The Funding Agreement was in two parts: the Evergreen Document, containing the elements of the Funding Agreement which were to remain constant ; and the Annual Funding Agreement that included aspects of the agreement that needed to be negotiated annually. A bundle of extracts from the Performance Monitoring Unit‟s Accountability Documents are produced as JMG/MOH/0073. The requirements for the THA to purchase the NCSP and cervical screening services was in the Evergreen Document (see 1997/98 p.56). The NCSP was to be purchased consistent with the updated 1996 National Cervical Screening Programme Policy, including for laboratories a requirement that they be TELARC registered or equivalent and as specified in the Service Obligation (see 1996 Policy GRB/MOH/0001 pp.20 and 40). 300. Additional requirements from the previous year included Pacific people requirements (for example, access to educators and cervical smears takers who were Pacific women), and that the funder should involve women from the target groups in the development of services. The service obligation in the 1996 National Cervical Screening Programme Policy also specified requirements governing the purchase of the NCSP and laboratory services by the funder consistent 92 with the previous year. At this stage, further monitoring processes were still to be developed by the Ministry. These included: 300.1. the screening history of all women developing invasive cancer, to be done on an ongoing basis, including reassessing smears; 300.2. variations in laboratory reporting practices; 300.3. sensitivity and specificity of smears in detecting abnormalities. 301. The 1998/99 Funding Agreement was agreed with the (newly established) HFA. This included a Service Coverage Document, which described services to be publicly funded by the HFA. The NCSP was to be purchased for all eligible women according to the 1996 NCSP policy (see GRB/MOH/0001) and the Health Act 1956 Section 74A; colposcopy and cervical treatment services were to be purchased from secondary and tertiary surgical services; and laboratory diagnostic services as for previous years (see JMG/MOH/0075, 1998/99, pp. 16, 34, 108-9, 123-5). 302. The current 1999/00 Funding Agreement purchasing requirements for cervical screening are similar and incorporated within the Public Health and Prevention Services section of the Service Coverage document; colposcopy and cervical treatment services, and the standard for colposcopy waiting times, are in the Specialist Medical and Surgical Services section (see JMG/MOH/0073, 1999/00, pp.123-6, 108-11). 303. Each quarter the funder is required to provide to the Ministry the percentage of the eligible population enrolled on the NCSR. The third quarter is to include coverage, ie percentage of eligible women enrolled who have had a smear in the last five years. Statistical data from the NCSR is provided annually to the Ministry. 93 Quarterly reports on funder performance 304. The funder is required to supply the Minister with quarterly reports within a set timeframe at the end of each quarter (formerly six weeks from RHAs and currently 15 working days of the end of each quarter with the HFA). The 1995/96 Funding Agreement with RHAs states that the quarterly report was to include: 304.1. any quantitative performance indicators in the schedules; 304.2. commentary on any significant deviations from the performance indicators or other relevant matters; 304.3. a report on material issues with respect to public health or the purchase of public health services, and the significance and extent of those issues, including whether there is a threat to life, financial implications, and the risks associated with action and non-action. 305. Information from the funder is assessed by the Ministry. Plans to address any arising issues or risks are negotiated with the funder and followed through to ensure action was taken to resolve them. The Minister is briefed on these issues each quarter. Reports to the Minister are prepared by the Performance Monitoring Branch of the Ministry. Extracts from relevant reports are produced in a bundle as JMG/MOH/0074. 306. Monitoring of the NCSP featured prominently in the quarterly reports over the years. Colposcopy waiting times were included in all quarterly reports until 1997/98. They were then reported on as service coverage issues. 94 307. The standard waiting times for a colposcopy after a woman has had a problem identified from a cervical smear are four weeks for a high- grade smear (CIN 2/3) and six months for a low-grade smear (CIN1). RHAs were required to report to the Ministry how many women were waiting each quarter (from each CHE/HHS) and identify strategies they had in place to reduce waiting times outside the standard. 308. Two other key issues raised and followed through during this time involved problems with the backlog of enrolments on the Auckland Register (discussed later); and issues around electronic data entry of histology results on the Registers. Other matters reported less frequently involved service highlights. For example, in Quarter Two Report 1996/97, Midland RHA reported that Tairawhiti had appointed a Mäori Advisory Group to advise on cervical screening services for Mäori women (see JMG/MOH/0074, Quarterly Report on RHA Performance, Quarter Two, p.L2). 309. Other issues raised in the quarterly reports included enrolment issues and issues regarding the Register. 310. An example of Register issues is noted in the same Quarterly Report on RHA Performance, Cervical Screening at pp L3-4, in the section relating to electronic transfer of test results from laboratories to the NCSR from all RHAs: “The Ministry had concerns about the lack of electronic transfer of test results from laboratories to the NCSR. RHAs are required to use reasonable endeavours to ensure that all labs transfer this information electronically to the NCSR within certain timeframes. The Ministry was aware that a large proportion of the laboratories were not transferring information electronically, and not within the timeframes. Northern RHA 95 The RHA was not aware of this problem until the Ministry bought it to their attention in the quarter report letter. They have followed it up with CHEs and note that all cytology results from labs are transferred electronically, but not histology. Two hundred of these are being sent per week in hard copy. The RHA will discuss this with the labs with a view to providing the Ministry with a report by 30 April 1997 which will outline any problems in resolving this issues and providing a clear timeframe for resolution.” 311. The report also noted action being taken by Midland and Central RHAs on this issue. Southern RHA advised that it did not have a problem with its providers. 312. The formal accountability arrangements in place during 1997/98 required the THA and subsequently the HFA to report quarterly to the Ministry against 12 accountabilities, which were aggregated under the following three headings: 312.1. Management Expectations - which focused on the Government‟s interest in the THA as its owner; 312.2. Policy Priority Areas - which focused on those areas where specific health gain was targeted for that year (cervical screening was not a target area); 312.3. Access and Standards - which focused on the THA‟s role in delivering appropriate services (delivery of cervical screening was covered under this heading). 313. These accountability arrangements changed the focus and style of the performance reports produced for the Ministry, as the THA was required to report principally on an exceptions basis against high-level 96 expectations. There was little reporting of the THA‟s activity and no specific reference to cervical screening. 314. The 1998/99 Funding Agreement had no performance measures specifically related to cervical screening or colposcopy waiting times because this was covered in the Evergreen document. A requirement to supply quarterly information concerning the NCSP was specified in Appendix A (see JMG/MOH/0072 1998/99 Funding Agreement, p.49, Appendix A Information Requirements). Enrolment and coverage information was specified. 315. The Ministry‟s report to the Minister on the HFA‟s first and second quarterly reports for 1998/99 noted that the Ministry was concerned about waiting times for colposcopy on the North Shore (see JMG/MOH/0074 Quarter One, 1998/99 and Quarter Two 1998/99). 316. In the third quarter report the HFA confirmed that by the end of the quarter all hospitals had met the colposcopy waiting times except Northland Health, Waitemata Health and Auckland Healthcare, South Auckland Health and Capital Coast Health (see JMG/MOH/0074 Quarter Three 1998/99, pp.37-38). The Ministry‟s report noted that the HFA was working with all five hospitals to bring waiting times within the prescribed maxima. The report notes that after the end of the quarter concerns surfaced that cervical screening tests in Gisborne may have been misread and describes the HFA‟s response to this issue. 317. The fourth quarter report for 1998/99 comments that by the end of the quarter the number of women waiting longer than expected for colposcopies continued to decline, and that in quarter four there were four hospitals exceeding waiting times (see JMG/MOH/0074 97 Quarter Four 1998/99, p.46). This report noted that hospitals were looking closely at possible data problems and that the HFA was increasing the volume of colposcopies in contracts. Concerns over reporting of cervical screening tests were noted, together with the HFA‟s response. 318. The issues being monitored by the Ministry for the current 1999/00 Funding Agreement relate to ongoing progress with reducing waiting times for colposcopy, and the HFA management of the Gisborne investigation. Operational monitoring of the NCSP 319. From the establishment of the NCSP in 1990 until the present day, a significant component of the monitoring of the Programme has been at the operational level. Operational monitoring has been carried out by regional Programme Managers, the National Co-ordinator, the Department/Ministry of Health, the HFA, staff working nationally and regionally on the Register (such as systems administrators), and expert advisory committees (the CSAC and CALC/CSLAC). Their roles are outlined below. NCSP Programme Managers 320. The role of regional NCSP Programme Managers was to promote and implement the NCSP in their AHB. In this role, there was a major emphasis on liaising and networking with a wide range of local providers and community groups. The range of local providers spanned public health and personal health service boundaries, and included GPs, nurse smear takers, treatment services, health educators, and laboratories. Programme Managers also networked 98 with women‟s groups and Mäori and Pacific groups promoting the NCSP, consulting over implementation, and smoothing out implementation problems. 321. This liaison, networking and relationship management role was also, in effect, an operational monitoring role. Where regional Programme Managers noted or had concerns raised with them about performance quality or systems glitches, they were responsible, in the first instance, for endeavouring to resolve the issues at a regional level. When resolution at a regional level was not possible, the Programme Managers often raised the issues with the National Co-ordinator or at Programme Managers‟ quarterly meetings. I produce as JMG/MOH/0075 a bundle of minutes of those meetings as available from the Ministry files. 322. Another operational monitoring function was performed by the Register staff, contractors and systems administrators. Staff based at the Central Register met regularly with systems administrators from regional Programmes to discuss Register issues. Register staff also had a close working relationship with Programme Managers, smear takers and laboratories. They often referred quality issues to the Programme Managers, National Co-ordinator, and advisory committees, and in turn, matters were referred to them for advice or action. NCSP National Co-ordinator 323. The National Co-ordinator had a similar operational monitoring role to the Programme Managers, linked to the liaison, consultation and public relations aspects of her position. She visited regional Programmes and liaised with national organisations such as the Royal 99 New Zealand College of General Practitioners, the New Zealand College of Obstetricians and Gynaecologists, the New Zealand Nurses‟ Organisation, the Maori Women‟s Welfare League, and the Federation of Women‟s Health Councils Aotearoa New Zealand. 324. Her visits to regional Programmes provided valuable information on the way providers were implementing the NCSP. 325. The National Co-ordinator acted as an advisor to regional NCSP staff. This included explaining policy settings, referring matters to the CSAC, CALC or CSLAC, or to the Register co-ordinator. 326. The National Co-ordinator also followed up concerns raised in correspondence to her or to the Minister, or raised in advice from advisory committees or the systems administrators. An example of this occurred in 1998 in relation to concerns about lack of consistency in laboratory reporting to the NCSR. The National Co-ordinator organised a meeting with representatives from the Royal New Zealand College of Pathologists, the New Zealand College of Obstetricians and Gynaecologists and other professional organisations to agree on consistent reporting standards and a number of other issues. A copy of the minutes of this Expert Group meeting on 13 May 1998 is produced as JMG/MOH/0076. 327. Another example of NCSP communication with staff and stakeholders is the newsletters produced by the Programme. These were sent to between 1600 and 2000 addresses, including interest groups and individuals. A bundle of copies of newsletters available from Ministry files is produced (out of sequence) as JMG/MOH/0080. 100 328. The National Co-ordinator briefed the Minister on the NCSP at regular intervals using information gathered through her wide networks as well as from formal monitoring. 329. Information gained through operational monitoring could be escalated to the formal monitoring procedures. An example is the process used to resolve the backlog in Auckland Register enrolments. 330. The Auckland Register backlog was raised at a systems administrators‟ meeting in March 1995. This can be seen from the Minutes of the Systems Administrators Meeting of 15 March 1995, a copy of which I produce as JMG/MOH/0077. It was discussed later by the Auckland Programme Manager and the National Co-ordinator. 331. The Ministry‟s Performance Monitoring and Review section raised the issue with the RHA, North Health, and the situation was commented on in the Ministry‟s review of North Health‟s 1995/96 second quarter report (see JMG/MOH/0074, Quarter Two: October to December 1995, pp.13-14). The capacity of the Register software was identified as a contributing factor. Extra memory was added, but the backlog continued. 332. Ministry staff visited the regional site at Auckland Healthcare and held discussions with the RHA. It became apparent that the Auckland Register was under-resourced for the population it served and that without increased resourcing the backlog would grow. 333. The quarter three report states that North Health had increased the funding to the Auckland Register to employ extra staff to clear the backlog for 1995 enrolments and cytology (JMG/MOH/0074, Quarter Three: January to March 1996, pp.13-14). A further one-off 101 payment was made to clear the 1996 backlog. Furthermore, a new contract was developed that would link payment to the number of enrolments and smears processed (JMG/MOH/0074, Quarter Four: April to June 1996, p.20 and Quarter One: July to September 1996, p.128). These measures cleared the backlog (JMG/MOH/0074, Quarter Two: 1 October 96 to 31 December 96, p.L4). 334. A Ministry briefing to the Associate Minister in March 1996 on progress on clearing the Auckland Register backlog noted the continuing delays and the work being undertaken by the Ministry, North Health, and Auckland Healthcare. (see memorandum dated 28 March 1996 produced as JMG/MOH/0038). Advisory Committees 335. Advisory committees also played a role in formal and operational monitoring. 336. The CALC operated from 1989 to 1994 as an advisory committee independent of the NCSP/Department of Health. The CALC gave advice on laboratory issues to the NCSP and to its members‟ sponsoring organisations. It also assisted the Ministry when concerns arose. In Part Two of his evidence, Dr Boyd gives an example of a concern about a laboratory‟s smear reporting, which was referred by the National Co-ordinator to the CALC for advice. 337. The CSAC formally reported to the Minister on a range of issues affecting the NCSP, and had a close working relationship with, and advisory role to, the Department/Ministry of Health (see Appendix). The CSAC advice on quality issues was followed up by the NCSP at the Minister‟s request, or given directly to the NCSP for their 102 consideration. CSAC also liaised with its member organisations and with relevant professional organisations, women‟s groups, Mäori and Pacific groups on issues relating to the NCSP and quality. The Register as a monitoring tool 338. The Department/Ministry of Health, AHBs, the funder, the Programme Managers, and the advisory committees have all used Register information as an objective measure of quality. The Register provided statistical information on enrolment, coverage, smear taking, the nature of cervical cytology results, and comparisons on a regional basis of laboratory reporting practices. 339. At a regional level, the Register provided regional Programme Managers with valuable information on the NCSP in their area, and they were able to feed back data to laboratories on their reporting practices. 340. As explained earlier in my evidence, a factor contributing to the difficulty in obtaining information from the Register for national monitoring was that, until 1997, the Register consisted of 14 separately sited and separately controlled regional Registers. These regional Registers had strict confidentiality controls. The National Co-ordinator had to liaise with regional co-ordinators to extract information from the regional Programme registers. In its 1994 report, First Three Establishment Years the CSAC commented that, at that time, the NCSP was required by the security protocol of one local site to obtain the approval of the local ethics committee before releasing the data to the Ministry of Health (see JMG/MOH/0035). 103 341. Three statistical reports on the NCSP were produced, each progressively providing more information in 1993, (see JMG/MOH/0026), 1995 (JMG/MOH/0037), and 1998 (JMG/MOH/0051). The reports provided data to assist with monitoring at both national and regional levels and to provide providers with comparative information. 342. In the early 1990s the Register held only small volumes of data. The first statistical report on the NCSP was prepared from the Register in mid-1992 (published 1993) when the Register had been in operation only a short time. Most AHBs began enrolling women after early 1991, and the Register held only around 102 000 results, most representing a single smear from individual women. One AHB was unable to provide any information for the report. 343. The second statistical report covered the analysis of data to 30 June 1994. This report covered a limited time period due to the unavailability of data from the Auckland Programme after that date. 344. From 1995, release of aggregated data on Mäori women was subject to the Health (Cervical Screening (Kaitiaki)) Regulations 1995. These regulations were designed to protect Mäori women‟s data but meant that ethnic data is not readily available for statistical purposes. The Foreword to the second statistical report stated that a Mäori statistical report had been prepared and referred to the Kaitiaki Group. This report, which was not finally released until 1999, compared data of Mäori and non-Mäori women on the Register up to 31 December 1995 (see LRE/MOH/0004; Statistical Report on Mäori Women’s Data (1999)) . 104 345. The statistical reports have progressively provided more information. The third statistical report, published in June 1998, covered the following: 345.1. progress on NCSP targets; 345.2. enrolment numbers, including number of smears taken, and the proportion of the eligible population on the NCSR; 345.3. reported screening history of women at time of enrolment; 345.4. smear volumes and screening frequency; 345.5. adequacy of cervical smear taking; 345.6. cervical cytology, including the proportion of abnormalities detected as low-grade intra-epithelial lesions; 345.7. histology reports; and 345.8. cytological quality and reporting. 346. The Department/Ministry of Health did not produce any further statistical reports for a mix of reasons. The three yearly screening cycle of the NCSP limited the usefulness of more frequent reports, and there were significant resourcing implications for the Department/Ministry of Health in production of the reports. In 1998 the responsibility for producing national statistical information transferred to the HFA with the transfer of the NCSP. Evaluation 347. The need for evaluation of the NCSP has been an issue under discussion since the inception of the programme. 348. The ultimate objective is to monitor the programme against outcome objectives. A December 1991 proposal for discussion of an 105 evaluation for the NCSP prepared by the Health Research Services of the Department stated that: “…because the time lag before impact of the programme is reflected in statistics, monitoring and evaluation of various aspects of the programme planning and implementation becomes important.” A copy of the proposal is produced as JMG/MOH/0078. The same proposal noted that aspects of the NCSP that could be monitored towards evaluation were: 348.1. coverage (how many women of the total enrolled are rescreened within the NCSP); 348.2. quality of the smear by the smear taker; the number of smears analysed by laboratories; the number of laboratories accredited by TELARC; and the number of smears read in laboratories accredited by TELARC; 348.3. recall of women due; 348.4. follow up (the number of women with abnormal smears referred for treatment). 349. The need for evaluation of the effectiveness of detection and treatment was also raised in earlier reviews and reports. In practice recommendations for evaluations tended to be made with an eye to the eventual possibility of what could be done as opposed to what was actually possible with the Register capabilities at the time. It was envisaged that the Register would allow cytology and histology data for the same woman to be audited to identify deficiencies in smear reading and treatment. 106 350. As explained in the Register section of this evidence, however, linking of cytology and histology has only been possible since the reconfiguration of the Register, so that evaluation that focuses on practice and treatment has only been possible since mid-1997, and is still limited today by some gaps in histology results. 351. Evaluation also requires sufficient data for analysis to be meaningful and comparable to international benchmarks. In case of a screening programme it is important to have at least one complete screening cycle. The NCSP screening cycle is three years long, but internationally a five-yearly cycle is accepted. Sufficient data for evaluation can be considered to mean that a high level of women are being screened, at appropriate intervals, and that histology data is available where appropriate. Prior to the 1993 amendment to the Health Act, the number of women was too low to provide data for evaluation and only since 1997 has the histology been attached to women‟s records, enabling meaningful correlation. 352. What follows is a chronological account of the various evaluations, reviews and recommendations that have taken place since the start of the NCSP. Early recommendations The Ministerial Review 353. The Ministerial Review of 1989 and the Expert Group in 1990 both made recommendations relating to evaluation of the NCSP. One of the five sub-committees established by the Expert Group was specifically set up to deal with performance indicators and evaluation. 107 It commissioned a report by Judith Straton in 1990 which dealt with evaluation and monitoring issues. Straton recorded that epidemiological information for monitoring purposes did not seem to be routinely available as part of the Programme development to date, nor did it appear to be planned for. She recommended that a small working party be established, including an epidemiologist and a biostatistician, to define the data required for monitoring the NCSP and determine ways of extracting such data from the database (see JMG/MOH/0004 pp.21-22). 354. Straton criticised the fact that there had been no attempt to incorporate any formal evaluation into the pilot projects or any part of the NCSP planning to date. She noted that evaluation needed to feature from the outset in the planning stage so that appropriate data could be gathered operationally. She recommended that an evaluation component be incorporated into the planning of future cervical screening projects, including the delivery of services and the establishment of regional cervical screening registers. Funds needed to be specifically earmarked for evaluation and ideally such evaluation was to be co- ordinated nationally pp.62-63). 355. The Expert Group‟s report in 1990 (see JMG/MOH/0005), commented that, for the evaluation of the NCSP to occur at the national level, core information needed to be collected in a consistent manner. It was seen to be the responsibility of the National Co- ordinator to ensure monitoring and evaluation at a national level. In its report, the Expert Group also reiterated the Straton recommendations on continuing evaluation. In addition, the need for economic evaluation was identified for accountability purposes and to demonstrate efficiency in resource use. 108 Pilot projects 356. While the Ministerial Review, the Expert Group and the Straton report were dealing with cervical screening issues at a strategic level, several pilot projects were running at service provision level. These pilots had been started before the formal establishment of the NCSP. Four community projects were piloted in 1988-89 with the objectives of reaching the groups of women regarded as being at “high risk” and training women without health professional qualifications to take cervical smears (lay smear takers). 357. The projects established in Kaikohe and Wanganui had a specific focus on Mäori women. Other pilot projects in Nelson and Kawerau focused on the needs of low- income women. Two pilot programmes for the establishment of cytology registers were also undertaken in Marlborough (see JMG/MOH/0063 for an analysis of information) and Wanganui AHBs. 358. The Canterbury site‟s register was used as a “fast-track” evaluation of Register requirements and implementation before the NCSP was fully established (see JMG/MOH/0064 for an evaluation in June 1991). 359. Since the NCSP was established, local Programmes have undertaken a variety of evaluations on access and acceptability to inform local strategies for recruitment and better service provision. The CSAC and evaluation 109 360. The CSAC was appointed and first met in May 1991. The terms of reference for the new advisory committee included monitoring of treatment protocols and the provision of advice on evaluation of the NCSP (see JMG/MOH/0008). 361. In 1991 the CSAC produced two reports in respect of evaluation and monitoring. The first was dated 27 June 1991 and was entitled An Outline of Areas of Evaluation for the NCSP (see JMG/MOH/0013). The focus for evaluation was seen as being acceptability, accessibility, effectiveness and outcomes. 361.1. Acceptability of the Programme to both women and smear takers would be important to its success. 361.2. Accessibility would include population coverage within age groups or target groups. Measures should be made of area variation in service provision and use as assessed by the NCSP, providers and users. The influence of cost to women on their use was also seen as important. 361.3. Effectiveness was further seen as being separated into an examination of: 361.3.1. process measurements: in relation to smears taken, quality of smear reading, time taken for reporting, follow-up and treatment of women with abnormal smears, failures of follow-up, waiting times from referral to treatment. It was also noted that valuable information can be gained from reviewing the 110 screening history of women who developed cervical cancer. 361.3.2. outcomes: although mortality was the best measurement, the time lag associated with this meant that surrogates could be used, such as the detection of CIN3 and stage one cancer. Again the review of the screening history was said to be valuable. 362. As noted in the chronology section of my evidence, during October 1994 the CSAC submitted to the Minister the report Monitoring and Evaluation of the National Cervical Screening Programme: The First Three Establishment Years (see JMG/MOH/0035). This report was primarily an overview of past events and identification of themes in relation to monitoring and evaluation of the NCSP. Recommendations included a call for stability in Programme staffing, the endorsement of the 1993 findings that a separate operational unit for the NCSP be set up within the Ministry, the need to move towards routine instead of project-based evaluation and monitoring, and the increased need to identify effective health promotion strategies. Evaluation referred to in policy statements 363. The 1991 Policy Statement for the NCSP included a reference to evaluation and monitoring which effectively was a summary of the August 1990 Expert Group references to these matters. It stated that evaluation of the NCSP required certain core information to be collected in a consistent manner across AHBs. This was seen as relating to technical aspects of the NCSP. Further, the National Co- ordinator should be responsible for ensuring that the NCSP would be 111 monitored and evaluated nationally and that evaluation of projects and services nationally will be co-ordinated by the Department of Health. Economic evaluation of efficiency in resource use should also be undertaken. 364. When, in October 1993, the Government Policy for National Cervical Screening was updated to take account of structural changes in the reformed health sector, the 1991 text on evaluation and monitoring essentially remained the same, with the only difference being that the focus of fulfilling performance indicators became the responsibility of the RHAs. 365. In November 1993 the KPMG report Review to Determine the Appropriate Location of the Co-ordination of the National Cervical Screening Programme (JMG/MOH/0030) described evaluation and monitoring as being the establishment of baseline information, the development and monitoring of performance indicators, the analysis of national data, and the incorporation of the evaluation data into the ongoing operation and policy for the NCSP. Having consulted various government policy agencies, the RHAs, representatives of Programme Managers, Mäori screening co-ordinators, women‟s organisations and the CSAC, the reviewers reported that a shift of focus to increased monitoring and evaluation with the aim of reducing the incidence of cervical cancer was supported. 366. The 1996 policy document recorded the Ministry‟s responsibility for ensuring that the NCSP was monitored and evaluated nationally. Among the processes to be developed by the Ministry for monitoring and evaluation were: 112 366.1. the proportion of patients with abnormal cytology who have been followed through to diagnosis; 366.2. the screening history of all women developing cervical cancer, to be done on an ongoing basis, including reassessing previous smears; 366.3. the proportion of smears taken outside the guidelines (i.e., roughly one smear every three years per women aged 20-69 years and follow-up smears for normal or unsatisfactory smear); this should not exceed 10 percent; 366.4. variations in laboratory reporting practice; 366.5. sensitivity of smears in detecting abnormalities; 366.6. whether the invasive cervical cancer which are found were detected at regular screening or by another method. 367. The reasons why this had not been done to date in respect of screening histories and treatment are described earlier in this section. 368. Alterations to the Register to enable the capacity for histology data collection was a lengthy process which is discussed in the section on the Register. What was not explicitly stated was that a large proportion of histology information was still lacking and the Register needed to catch up with collecting this information before evaluation could realistically be considered. 113 Ministry of Health evaluation 369. Funding for an extensive NCSP evaluation was first included in the Ministry‟s budget in 1996/97. The Ministry requested proposals for the development of a draft scoping plan for the evaluation in August 1996. The tender was let to a team from Otago University, led by Dr Brian Cox. The draft evaluation plan was completed in June 1997. The estimated costs of a complete evaluation well exceeded the funding available and it was decided to request stakeholders‟ views on the priorities for evaluation. Extensive public consultation occurred. Stakeholders consulted included health professionals, women‟s health lobby groups, women‟s organisations and cytopathologists. 370. However, the consultation on priorities was inconclusive. On the advice of the CSAC, and in keeping with best practice overseas, it was decided to concentrate on three aspects that would highlight safety and quality assurance. These aspects were: 370.1. An assessment of NCSR data for evaluation of the Programme; 370.2. An assessment of the appropriateness of followup and treatment of women with abnormal smears. This will also indicate the specificity of cervical screening in New Zealand, i.e. the ability of a screening test to correctly identify a person who is free of abnormality; 370.3. An audit of the screening histories and treatment of women who have invasive cervical cancer. The audit will be both retrospective and prospective for the duration of the 114 evaluation. The audit of screening histories of women who have recently developed cervical cancer will assess screening history and medical history as well as interviewing women, their clinicians and pathologists where possible. As part of the audit the evaluation will also look at women who developed cancer but were not enrolled on the Register. 371. The contract for the evaluation was signed in May 1999. The Ministry of Health has retained the responsibility for contract management. The Ministry‟s evaluation will take almost two-and-a- half years to complete and cost approximately $400,000. The evaluation team anticipates that it will interview about 700 women. Both parts of the evaluation require extensive ethical approval. 372. The HFA took over the responsibility for the co-ordination and the strategic development of the NCSP from the Ministry in 1998. It is currently undertaking an internal review of operational aspects of the NCSP and has identified areas that need strengthening and improving. Health outcome targets for cervical screening 373. In 1986 the climate of medical opinion held that without effective cervical screening, cervical cancer mortality and incidence was expected to increase. The risk of cervical cancer had increased very rapidly in cohorts of women born since the 1930s. It had been estimated that a woman born in 1957 could have over three times the risk of dying of cervical cancer than a woman born around 1932 (see GRB/MOH/0008). Projections had indicated that without an organised screening programme up to 500 women could develop cervical cancer and 150 women die of it each year up to the year 2000. The cervical cancer incidence and death rates could be expected to 115 increase by about 45 percent and about 20 percent respectively by the year 2005 in the absence of an effective cervical screening programme. I produce an extract from B Cox, Projections of the Cancer Burden in New Zealand, September 1995, pp.16, 49-50, as JMG/MOH/0079. 374. Targets for reduction of mortality and incidence were included in the Expert Group‟s policy statement of August 1990 (JMG/MOH/0005). They were: 374.1. by the year 1995, to increase to 80 percent or more the proportion of all women aged 20-64 years who have in the previous three years been screened for pre-invasive cancer and provided with appropriate follow-up diagnosis and therapeutic services; 374.2. by the year 1995, to reduce the death rate from cervical cancer in women aged 20 to 64 years by 20 percent or more in Mäori and by 10 percent or more in Pakeha and Pacific women; and by the year 2000, to reduce the death rate by 50 percent or more in Mäori and 25 percent or more in Pakeha and Pacific women; 374.3. by the year 2000, to reduce the incidence of invasive cervical cancer to fewer than 180 cases annually; 374.4. by the year 1995, to increase to 45 percent or more the percentage of invasive cancer detected at stage 1 of the disease. 116 375. Over time some of these goals were adjusted. The upper age limit was extended from 64 years to 69 in 1992 as a result of the report Cancer Screening, 1991 Cervical Screening Recommendations [Paul et al] (JMG/MOH/0010). The same report also stated that the recommendations should be reviewed after five years, when there should be sufficient information on the Register to evaluate the success of the NCSP. This recommendation envisaged linking of histology to cytology reports and an improvement of the Cancer Registry. 376. The PHC, and the Ministry of Health since the PHC was disestablished in 1995, have monitored the progress of the NCSP against outcome targets as one of a number of specified public health targets intended to monitor the strategic direction for public health. 377. The Public Health Commission also stated outcome targets in 1993 (JMG/MOH/0031). They were: 377.1. by the year 1995, to reduce the death rate from cervical cancer in women aged 20-69 years by 20 percent or more in Mäori, and by 10 percent or more in non-Mäori; and by the year 2000, to reduce the death rate by 50 percent or more in Mäori and 25 percent or more in non-Mäori; 377.2. by the year 2000, to reduce the incidence of invasive cervical cancer to fewer than 180 cases annually; 377.3. by the year 1995, to increase to 45 percent or more the percentage of invasive cancer detected at stage 1 of the disease; 117 377.4. by the year 1995, to increase to 80 percent or more the proportion of women aged 20-69 years who have in the previous three years, been screened for invasive cervical cancer and provided with appropriate follow-up diagnosis and therapeutic services. Screening should cover all ethnic groups, excluding women who have had a total hysterectomy for a benign condition or who have never had sexual intercourse; 377.5. to increase the proportion of eligible women enrolled on the Register to 75 percent by the year 1996 and to 85 percent by the year 2000. 378. The National Cervical Screening Programme Policy 1996 (GRB/MOH/0001) also included specific targets for mortality and incidence expressed in age-standardised rates per 100 000 women as follows: 378.1. mortality: to reduce the age standardised death rate from cervical cancer from 4.2 in the 1989-93 time period to below 3.5 per 100 000 women by the year 2005 (this had reduced to 2.8 in 1997); 378.2. Mäori mortality: to reduce the rate from 10.6 in the 1989-93 time period to 7.5 per 100 000 Mäori women by the year 2000, and to 5.3 per 100 000 or less by 2005.(this had reduced to 7.4 in 1994); 378.3. incidence: to reduce the age-standardised incidence rate of cervical cancer in women from 12.0 per 100 000 women in the 1989-93 time period to below 8.6 by the year 2005 (this had reduced to 8.8 in 1997); 118 378.4. Mäori incidence: to reduce the incidence rate of cervical cancer in Mäori women from 29.8 per 100 000 Mäori women in the 1989-93 time period to below 11.0 by the year 2005 (this had reduced to an average rate of 23.0 by 1994). 378.5. early detection: no more than 30 percent of invasive cervical cancers detected should be beyond stage 1 at the time of detection by the year 2000. 379. The health outcomes and effectiveness of the NCSP are shown in the table below. Mortality Incidence per per 100 000 100 000 women women Predicted rates in absence of 5.0 16.2 screening programme 1997-2002 1987-89 (pre NCSP) 4.9 13.4 1989-93 4.2* 12* 1994-96 3.7* 9.7* 1997 2.8* 8.8* *age-standardised rate 380. The reductions in rates show a trend in decreasing mortality and incidence rates versus a predicted increase in mortality and incidence in the absence of a screening programme. 381. The cervical cancer and cervical cancer screening enrolment targets have been based on cervical screening policy statements. Participation in the NCSP is usually expressed in enrolment figures and coverage. Enrolled women are defined as any woman on the Register who is on the recall system. Coverage means women who have had a smear test in the NCSP within the previous five years. 119 Coverage rates give an indication of the proportion of women who are returning for regular screening. 382. The initial target was to increase the proportion of eligible women enrolled on the NCSR from 18 percent in 1992 to 75 percent in 1996. This target was exceeded in 1996. The revised target for 2000 increased the desired five-year coverage rate for eligible women to 85 percent. This target was achieved in February 2000. Current enrolment is 91 percent of eligible women. 383. The percentage of the eligible women population enrolled on the NCSR, as at the end of each calendar year 1991-99 is shown in the table below. 1991 1992 1993 1994 1995 1996 1997 1998 1999 7% 18% 33% 55% 68% 81% 83% 88% 91% Note: The 1991-96 figures are based on the 1991 Census population. 384. National 5-year coverage rates were reported on only from 1997. The national coverage rates are: 1997 1998 1999 82.83% 83.88% 84.85% 385. The 1997-99 figures are based on the Statistics New Zealand population estimates as at 31 March of that year, less an adjustment for women who have had a total hysterectomy for a benign 120 condition. The Statistics New Zealand population estimates were in turn based on the 1996 Census population. 386. Although overall targets in incidence and mortality continue to be met, the rates for Mäori women are at least twice as high as those for non-Mäori women. Mäori women‟s data are available for the period ending 1995 (see LRE/MOH/0004). Mäori women and older women continue to be priority target groups for the NCSP. 387. The progress made in establishing the programme and reaching optimum enrolment and coverage so quickly has been envied by screening programme providers in other countries. The high number of women enrolled on the programme indicates their acceptance of the NCSP as part of mainstream health care. The cervical cancer mortality and incidence (number of new cases of cancer) rates are declining, which indicates that the health outcomes anticipated at the start of the NCSP are being achieved. ___________________________________ Judith Margaret Glackin ___________________________________ Date 121 EXHIBITS PRODUCED BY JUDITH MARGARET GLACKIN 1. Report of the Ministerial Review Committee on November 1989 Implementation of a National Cervical Screening Programme (“Ministerial Review Report”) 2. Memorandum to the Minister of Health from the 15 December 1989 Department Job Description for National Co- ordinator and Area Health Board Programme Manager 3. Promoting Cervical Screening – Information for 1990 Health Workers Department of Health 4. Straton, Judith AY Review of the National Cervical July 1990 Screening Programme in New Zealand (“The Straton Report”) 5. NCSP Report of Expert Group to the Minister and May/August 1990 policy statement of the NCSP Expert Group (“The Expert Group Report”) 6. Memorandum to Director General of Health from the 18 October 1990 Minister of Health 7. Memorandum to the Associate Minister of Health 6 December 1990 from the Department 8. Memorandum to the Associate Minister of Health 28 January 1991 from the Department 9. Draft press release from the Associate Minister of 1 February 1991 Health Cervical Screening Advisory Group 10. Paul C, Bagshaw S et al Cancer Screening, 1991 1991 Cervical Screening Recommendations 11. Bundle of documents comprising Terms of Reference, Agendas and Minutes of the Cervical Screening Advisory Committee (“CSAC minutes”) 12. CSAC paper: Final Steps for an effective NSCP 22 July 1991 13. Cox B, An Outline of Evaluation for the National 27 June 1991 Cervical Screening Programme 122 14. Cox B, Cervical Screening in the New Health Service 26 August 1991 Structure 15. Government Policy for National Cervical Screening Reprint February (1991) (“The 1991 Government Policy”) 1993 16. Service Statement for Area Health Boards: Cervical April 1991 Screening 17. CSAC Submission Submission to the PHC 20 February 1992 Implementation Group by the National Cervical Screening Advisory Committee 18. CSAC discussion document Cervical Screening in 18 August 1992 the Reformed Health Service: A Discussion Document 19. Minutes of NCSP meeting of agencies with an 10 December 1992 interest in the NCSP under the reformed health sector 20. NCSP background paper for 10 December 1992 10 December 1992 meeting of agencies with an interest in the programme under the reformed health sector 21. Meeting of Working Group to discuss cervical 13 January 1993 screening programme in reformed health sector 22. Abnormal Cervical Smears – National Consensus on June 1992 a Treatment Protocol for Management (“the Treatment Protocol”) 23. Histology Requirements for National Cervical April 1993 Screening Register J Phuar (Azimuth Consultants Limited) 24. Memorandum to the Minister of Health from the 23 December 1993 Ministry National Cervical Screening Programme – Register Configuration 25. Norton V The National Cervical Screening June 1993 Programmes Review of Laboratory Services (“the Norton Laboratory Review”) 123 26. Cox B, Brackenbury J, Teague C The First Statistical 1993 Report of the National Cervical Screening Programme; Analysis of Data to 18 August 1992 (“First Statistical Report”) 27. Government Policy for National Cervical Screening October 1993 – Updated October 1993 (“The 1993 Government Policy”) 28. An internal memorandum from Sonja Easterbrook- 18 March 1993 Smith to Director-General 29. Letter from Acting Director General to Dr Gillian 2 September 1993 Durham 30. KPMG Peat Marwick Review to Determine the November 1993 Appropriate Location of the Co-ordination of the NCSP (“KPMG Location Review”) 31. Public Health Commission Cervical Cancer the March 1994 Public Health Commission’s Advice to the Minister of Health 1993/94 (“PHC Advice”) 32. Letter from National Co-ordinator to listed 9 May 1994 organisations relating to the review of National Policy for Cervical Screening 33. Memorandum from National Co-ordinator to 8 August 1994 Director-General relating to Committees servicing the NCSP 34. Memorandum to the Associate Minister of Health 25 August 1994 from the Ministry relating to CSAC 35. CSAC report Monitoring and Evaluation of the October 1994 NCSP: The First Three Establishment Years 36. Letter from B Marshall to Associate Minister and November/ response December 1994 37. Linton M NCSP Second Statistical Report, Analysis 1995 of Data to 30 June 1994 (“Second Statistical Report”) 124 38. Memorandum to the Associate Minister of Health 28 March 1996 from the Ministry on the Performance of the NCSP 39. Ministry of Health Report Review of Accountabilities 11 April 1996 for the NCSP 40. Memorandum to the Minister of Health from the 7 May 1996 Ministry on the Review of Accountabilities 41. Memorandum to the Associate Minister from the 13 June 1996 Ministry re Review of Accountabilities 42. Letter to the Ministry from the Associate Minister of 5 August 1996 Health on the NCSP 43. Sample fax from Judy Glackin to various 27 August and 9 organisations re the role of the NCSP Co-ordinator September 1996 and KPMG supporting material 44. Letter from Associate Minister of Health to Dr Maree 24 September 1996 Leonard 45. Implementing the Coalition Agreement on Health – 30 May 1997 the Report of the Steering Group to Oversee Health and Disability Changes 46. Memorandum to the Minister of Health from the 24 June 1997 Ministry re consultation on the future location of the National Co-ordination for the NCSP 47. Cox B and Richardson A Draft Evaluation Plan for June 1997 the NCSP 48. Memorandum to Minister of Health from the 5 February 1998 Ministry re communication strategy to support the transfer of NCSP to the HFA 49. Turner G, Bagshaw S et al Recommendations for Cervical Screening 1997 NG Med J 1998; 111:94-8 27 March 1998 50. Guidelines for the Management of Women with Abnormal Cervical Smears (HFA publication) September 1998 51. Linton M NCSP Third Statistical Report, Analysis of 1998 Data to 31 December 1995 (“Third Statistical Report”) 125 52. Memorandum to the Minister of Health from the 22 April 1999 Ministry relating to the misreading of cytology smear tests 53. Memorandum to the Minister of Health from the 3 May 1999 Ministry re Gisborne Pathologists 54. Memorandum to the Minister of Health from the 20 May 1999 Ministry re risk to the public 55. Memorandum to the Minister of Health from the 21 May 1999 Ministry re cervical screening issues 56. Memorandum to the Minister of Health from the 27 May 1999 Ministry re risk to the public 57. Memorandum to the Minister of Health from the 9 June 1999 Ministry re risks to the public 58. Memorandum to the Minister of Health from the 13 July 1999 Ministry re risks to the public 59. Draft background paper prepared for the Inquiry by November 1999 Ministry of Health 60. List of core documents provided to the Inquiry by the November 1999 Ministry of Health at background briefing 61. Minutes of meeting at Ministry of Health including 3 November 1999 members of Inquiry team 62. Bundle of documents relating to the development of the NCSP within the Tairawhaiti Area Health District (“Tairawhiti bundle”) 63. Dowland J NCSP: Analysis of Information Collected October 1990 from the Marlborough Pilot Programme 64. Norton V The Evaluation of Canterbury Cervical June 1991 Screening Programme 65. Memorandum to Cabinet on Cervical Screening: 1 April 1992 Proposed Change to the National Cytology Register 66. Minute of the Cabinet Social and Family Policy 24 April 1992 Committee 126 67. Memorandum to the Associate Minister of Health 5 February 1993 from the Ministry re proposed number of Registers in the future 68. Drage J A Summary of the Responses Made to the April 1993 Department of Health Consultation Paper NCSP Registers: Options for Change 69. Bundle of extracts from the Department/Ministry of Health Annual Reports to Parliament 70. [deleted] 71. CALC submission on review Government NCSP June 1994 policy 72. Bundle of extracts from Funding Agreements 1993/4 to 1996/7 between Minister of Health and RHAs 73. Bundle of extracts from the Accountability 1997/8 to 1999/00 Documents held by the Performance Monitoring Unit of the Ministry 74. Bundle of extracts from Quarterly Performance Reports to the Minister on RHAs prepared by the Performance Monitoring Unit of the Ministry 75. Bundle of minutes of meetings of the NCSP 1991-1997 Programme Managers (“Programme Managers Meetings Minutes”) 76. Minutes of an Expert Group convened by the NCSP 13 May 1998 Co-ordinator 77. Minutes of the NCSP Systems Administrators 15 March 1995 Meeting 78. Adams J NCSP National Evaluation – Proposal for December 1991 Discussion 79. Cox B Projections of a Cancer Burden in New 1995 Zealand 80. Bundle of NCSP newsletters 1988 to1998 127 APPENDIX THE ROLES AND MEMBERSHIP OF NATIONAL COMMITTEES THE EXPERT GROUP : DEC. 1989 - JAN. 1991 Terms of reference: 1. provision of advice on national policy for the NCSP (including confirmation of register type, identification of women priority groups and the creation of health promotion strategies); 2. overseeing the implementation of the NCSP; 3. liaison with a National Co-ordinator; 4. oversight of the introduction of treatment protocols and monitoring of these, ensuring suitability of education and publicity material; and 5. setting performance indicators and targets and reviewing overall effectiveness of the NCSP (Expert Group - Terms of Reference). Membership Peggy Koopman-Boyden Chairperson Robin McKinlay Ministry of Women‟s Affairs Linda Erihe Te Korimako Mauriora Centre Ruth Bonita Public Health Association Sandra Coney Auckland Women‟s Health Council Joy Bickley New Zealand Nurses Association Clint Teague Cytology Advisory Liaison Committee Betsy Marshall The Cancer Society of New Zealand (Inc) Corinne Stevenson The Health Alternatives for Women Christine Roke New Zealand Family Planning Association Doreen Arapai Pacifica 128 Waireti Walters Mäori Women‟s Welfare League Peter Moodie The Royal New Zealand College of General Practitioners Howard Clentworth Royal New Zealand College of Obstetricians and Gynaecologists THE CERVICAL SCREENING ADVISORY COMMITTEE (CSAC): 1991 - 1998 Original terms of reference The role of the Committee was to: 1. provide advice on national policy for the NCSP; 2. provide advice on the implementation of the Programme; 3. liaise with the National Co-ordinator; 4. monitor treatment protocols; and 5. provide advice on evaluation of the NCSP. As a Ministerial advisory group, CSAC membership was determined by, and the Committee reported directly to, the Minister of Health. The Committee was originally chaired by Betsy Marshall of the Cancer Society. Amended terms of reference - 1994: The role of the Committee was to: 1. liaise with the National Co-ordinator and National Mäori Co-ordinator, who will inform the Committee on Ministry of Health work related to the NCSP, the purchase and provision of the NCSP, and any implementation or policy issues requiring attention and advice; 129 2. liaise with the representative of the PHC, who will inform the committee of PHC work related to the NCSP, and any policy issues requiring attention and advice; 3. provide ongoing advice and input into strategic and operational policy development; 4. provide advice on the monitoring and evaluation of the effectiveness of the NCSP; and 5. report in writing annually to the Minister of Health. Amended terms of reference - September 1996 The role of the committee was to: 1. provide advice on the evaluation and monitoring of the NCSP being undertaken by the Ministry of Health; 2. provide advice on strategic and operational policy issues related to the NCSP, referred to the Committee by the Minister or the Ministry, or identified by the Committee; and 3. report in writing to the Minister of Health. THE CYTOLOGY ADVISORY LIAISON COMMITTEE (CALC): 1989 - 1994 The Cytology Advisory Liaison Committee (CALC) was established in 1989 by the NZ Society of Pathologists in response to needs emerging from the 1988 Cartwright inquiry and report. There were eight members representing the professional pathology and cytology organisations. The CALC provided technical advice to the NCSP and assisted with communication with laboratories. While there were no formally agreed terms of reference between the CALC and the Department of Health, the Committee provided advice about both cervical cytology 130 and histology and the interface between the NCSP and laboratories, and assisted with ongoing work on quality and standards. The CALC initially identified three priority issues: 1. a cytology reporting system suitable for the NCSP; 2. training requirements for cytology screeners; and 3. manpower assessment (CALC, Terms of Reference Cytology Advisory Liaison Committee, circa 1990). In 1994 the CALC was established as a technical committee to the Ministry, and renamed the Cervical Screening Laboratory Advisory Committee (CSLAC). Cervical Screening Laboratory Advisory Committee (CSLAC): 1994 - 1996 The CSLAC provided technical advice to the Ministry of Health on issues relating to the interface between the NCSP and NCSR and laboratories providing cervical cytology and histology services. The role of the Committee was to: 1. provide technical medical advice relating to cervical cytology and histology; and 2. advise on the provision of quality laboratory services associated with the NCSP. The functions of the Committee were to: 1. liaise with the National Co-ordinator, who will inform the committee on the Ministry of Health work related to NCSP and laboratory issues requiring attention and advice; 2. advise the National Co-ordinator of laboratory issues requiring attention and advice; 131 3. assist the NCSP co-ordination team to effectively incorporate and correlate cervical histology results onto the NCSR; 4. provide advice on quality assurance relating to laboratory cytology and cervical histology diagnostic services; 5. advise the NCSP on appropriate training standards for cervical cytology; and 6. advise on the development of new technology and methods as appropriate. A Service agreement detailing the responsibilities of the Committee chair and the Ministry of Health was also negotiated for the period from July 1994 to 30 June 1996 (National Cervical Screening Programme, Ministry of Health. 1994. Cervical Screening Laboratory Advisory Committee Service Agreement, 1994). The CSLAC was disbanded in June 1996 at the expiry of its term.
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