Documents
Resources
Learning Center
Upload
Plans & pricing Sign in
Sign Out

Bottom cm

VIEWS: 7 PAGES: 136

									       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:

                 4.1.4.1 reading of a minimum number of smears per year;
                 4.1.4.2 employment of adequate numbers of suitably
                         qualified staff;
                 4.1.4.3 maximum workload for each cytoscreener;
                 4.1.4.4 adequate in-service education;
                 4.1.4.5 satisfactory participation in both external and
                         internal quality assurance procedures;
                 4.1.4.6 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.

								
To top