cervical screening inquiry annual review 2001/02 and ...€¦ · • andrew forsyth, team leader,...

CERVICAL SCREENING INQUIRY ANNUAL REVIEW 2001/02 AND

ANNUAL PLAN 2002/03

CSI Annual Review 2001/02 and Annual Plan 2002/03 November 2002

2

Introduction.....................................................................................3

Responsibilities ..............................................................................4

Summary of the Implementation of the Cervical Screening Inquiry Recommendations in 2001/02........................................................8

NCSP Operations.........................................................................10

Six Month Review.........................................................................22

Financial .......................................................................................24

Issues/Risks 2002/03 ...................................................................25

Summary of 2002/03 Plan............................................................28

2002/03 Budget ............................................................................38

Appendix 1: Inquiry Recommendations and Responsibilities.......39

Appendix 2: Summary of Reporting..............................................46

Appendix 3: Summary of Six-Month Reviews ..............................48

Appendix 4: April 2001 Plan .........................................................50

Appendix 5: Project Summary Plan..............................................54

Appendix 6: Glossary of Common Abbreviations .........................73


3

Introduction In April 2001 the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region released its findings including 46 recommendations (the Inquiry Recommendations) for the implementation of improvements to the National Cervical Screening Programme (NCSP). Refer to Appendix 1, Inquiry Recommendations and Responsibilities. A Ministry of Health-wide Steering Group, with the National Screening Unit (NSU) Group Manager as Chair, was set-up in May 2001. The Steering Group monitored implementation of the Inquiry Recommendations throughout 2001/02. Monthly progress reports were provided to the Minister. A Six-Month Summary Report was completed1. Refer to Appendix 2, Summary of Reporting, for a list of reports. Dr Euphemia McGoogan, cytopathologist and associate medical director of Lothian University Hospitals NHS Trust in Edinburgh, was appointed by the Minister to advise on progress to implement the Inquiry Recommendations. The Steering Group Chair and the Deputy Director-General Public Health regularly provided progress updates to Dr McGoogan. Dr McGoogan also visited New Zealand in November 2001 and provided to the Minister a six-month progress report2. As part of her six-month review of progress Dr Euphemia McGoogan made a series of further recommendations to improve the NCSP and the implementation process. These have been incorporated into an action plan. See Appendix 3, Summary of Six-Month Reviews. Dr McGoogan made a further visit to New Zealand in April 2002, and a third visit and a report on the work conducted to implement the Inquiry Recommendations is planned for January 2003. In addition the Office of the Controller and Auditor�General (OAG) conducted a review to determine the effectiveness of the actions that had been taken to implement the Inquiry Recommendations. The final report was published in February 20023. This document summarises the main activities carried out to implement the Inquiry Recommendations to June 2002. The risks and issues associated with the implementation of the Inquiry Recommendations for 2002/2003 are included together with a summary implementation plan for 2002/2003.

1 Ministry of Health. October 2001. The Six-Month Summary Report from the Ministry of Health to the Minister on the Implementation of the Recommendations of the Gisborne Cervical Screening Inquiry Report. 2 McGoogan E. 2001. Progress in Implementing the Cervical Screening Inquiry Recommendations: Independent Report . 3 Office of the Controller and Auditor �General. February 2002. Report of the Controller and Auditor �General: Ministry of Health: Progress in Implementing the Recommendations of the Cervical Screening Inquiry. Wellington: Office of the Controller and Auditor General.


4

Responsibilities The Cervical Screening Inquiry (CSI) Steering Group comprises managers from across the various Ministry directorates responsible for implementation of the Inquiry Recommendations.

Table 1: CSI Steering Group

• Karen Mitchell (Chair), Group Manager, NSU, Public Health Directorate

• Julia Peters, Clinical Director, NSU (to April 02), Public Health Directorate

• Judy Glackin, Manager, Health of Older People and Sector Regulation, Sector Policy Directorate

• Helen Wyn, Manager, Strategic Analysis, Sector Policy Directorate

• Grant Adam, Manager, Health Legal, Corporate and Information Directorate

• Andrew Forsyth, Team Leader, Public Health Legislative Review Team (PHLR), Public Health Directorate

• Ria Earp, Deputy Director -General, Maori Health Directorate (late 02)

• Kallon Basham, Senior Communications Advisor, NSU, Public Health Directorate

• Catherine Scollay, Information Services Manager, NSU, Public Health Directorate

• Colin Tukuitonga, Director of Public Health, Public Health Directorate

• New Zealand Health Information Service (NZHIS) (representatives in attendance from time to time), Corporate and Information Directorate

The work to implement the Inquiry Recommendations was grouped as follows:

• Audit of Invasive Cervical Cancer � initially coordinated by the NSU and then transferred to Director of Public Health in April 02.

• Ethics recommendations � Sector Policy Directorate • Legislation � Sector Policy Directorate coordinated the original proposal

for a Comprehensive Bill, which included amendments to The Injury Prevention, Rehabilitation and Compensation Act 2001, the Health and Disability Services Commissioner Act 1994, the Health Practitioners Competence Assurance Bill (HPCA), and the Health Act 1956. The original proposal for the Comprehensive Bill did not go ahead resulting in the Bill being split into its constituent parts. Specific responsibility for the amendments to S74A of the Health Act 1956 relating to the NCSP then transferred to the PHLR in February 2002.

• Kaitiaki Regulations Review � Maori Health Directorate

• NCSP Operations � NSU

• Information Technology � NSU and NZHIS


5

Responsibility for delivery of the Inquiry Recommendations was allocated to each of the Steering Group members as representing the various Ministry directorates and project teams. Refer to Appendix 1, Inquiry Recommendations and Responsibilities. Progress to deliver project requirements is measured by the CSI Steering Group on the basis of the achievement of key milestones related to the production of specific deliverables, project outputs and decisions. Various project teams from within the directorates provided monthly milestone reporting to the Steering Group Chair for the tracking of progress. To provide an objective means of measuring progress a milestone plan was formulated by the Ministry based upon the proposed timetable advised to the Minister in April 2001. See Appendix 4, April 2001 Plan. The April 2001 timetable was developed in advance of more detailed analysis of the Report of Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region (the Inquiry Report) and its recommendations and of the scope of work needed to deliver them. In the proposed timetable for the implementation of the Inquiry Recommendations up to 15 recommendations were stated as requiring up to 18 to 24 months or more to implement, given their complexity. Recommendations related to the development and implementation of new information systems were highlighted as requiring longer to implement. As the scope of the work became more evident over the first six months a revised timetable was presented and was included with the six-month summary report. Refer to Appendix 5, Project Summary Plan, for the revised dates. The CSI Steering Group has continued to measure progress to implement the Inquiry Recommendations based on the achievement of key milestones, project outputs and decisions and specific deliverables, which are indicated in the Implementation Summary for 2001/02 (Table 2.0), and the Summary Implementation Plan for 2002/03 (Table 4.0). Some recommendations may more easily be measured as completed as they have a finite period in which they can be implemented; however many other recommendations have an ongoing component that will eventually be incorporated as business as usual into the NCSP. An overall plan of the completion and implementation dates for each of the recommendations is provided as Appendix 5, Project Summary Plan. In her first six-month report, Dr Euphemia McGoogan, noted that there should be a revised approach to measuring the way recommendations were progressed and completed. It is anticipated that her second report will outline this new approach in detail. The Ministry is awaiting her report in order to implement her revised measuring process.

NSU The Ministry of Health is required to ensure the effective delivery of the NCSP, in accordance with the programme�s objectives and appropriate standards. The programme is for New Zealand women aged 20 to 69 years and contributes to the Crown�s objective to reduce the incidence and impact of cancer.


6

Of the 46 Inquiry Recommendations, 27 were either the direct responsibility of the NSU or required the input of NSU staff. The NSU is responsible for the national coordination and funding, policy development and monitoring of New Zealand�s two national cancer screening programmes: the National Cervical Screening Programme (NCSP) and BreastScreen Aotearoa (BSA). The NSU is an autonomous unit within the Ministry of Health Public Health Directorate. The 2001/02 year was the NSU�s first full year of operation. In addition to its core business, the NSU�s priorities for 2001/2002 included implementation of 19 of the Inquiry Recommendations, some of which commenced prior to the Inquiry report and many of which have an ongoing component as part of NCSP operations, including the:

• Audit of Invasive Cervical Cancer, (recommendation 1 - ongoing)

• implementation of interim quality standards with contracted providers, (recommendation 4 � achieved & ongoing except in relation to private colposcopists and smear takers who are non contracted providers)

• legal assessment of NCSP (recommendations 5 & 6 � achieved and ongoing)

• completion of 1996-98 Statistical Report, (recommendations 7 achieved and recommendation 8 ongoing)

• implementation of minimum volumes for laboratories, (recommendation 9 � ongoing)

• implementation of direct contracts with NCSP service providers, (recommendation 12 � achieved and ongoing except in relation to laboratories as contracts are held directly with District Health Boards (DHB�s)

• input to proposed amendments to Section 74A of the Health Act 1956, (recommendations 14, 15, 16, 17, 30 - ongoing)

• completion of Workforce Development Strategy, (recommendations 28, 40, 41, 42, - achieved and ongoing)

• provision of information to women, (recommendation 38 � achieved and ongoing)

• provision of information to smear takers, (recommendation 39 - achieved and ongoing).

Sector Policy Directorate Sector Policy Directorate provides strategic policy advice and analysis to the Minister of Health on the health and disability sector in New Zealand. Sector Policy Directorate houses the Secretariat for the National Ethics Advisory Committee (NEAC), and is also responsible for strategic policy advice on occupational regulatory frameworks. Sector Policy Directorate is responsible for the implementation of the Health Practitioners Competence Assurance Bill (HPCA) once enacted, which requires improved information flows between relevant agencies and systems


7

to support early reporting by medical practitioners (recommendations 34, 35, 36 and 44). This Directorate also has responsibility for providing secretariat support for NEAC. NEAC will prioritise within its work programme the recommendations that relate to the operations and process of ethical review of medical and health services research (recommendations 19, 21, 22, 23).

Māori Health Directorate The Māori Health Directorate provides advice on the strategic direction of the health and disability sector with respect to Mäori. The Mäori Health Directorate was responsible for engaging in consultation with Mäori women about reviewing the Kaitiaki Regulations and the future role of the National Kaitiaki Group (recommendation 15 of the Inquiry Recommendations). The Review of the Kaitiaki Regulations is now finished. Cabinet agreed to maintain the status quo, with improved processes for the NCSP to access Mäori women�s aggregate data. The role of the Mäori Health Directorate is now complete.

PHLR The PHLR was established 1 July 2000 to complete a major review of the Health Act 1956 with the view to its eventual replacement with a new Public Health Bill. In Feb 2002 the PHLR team assumed responsibility for the final drafting, introduction to Parliament and subsequent Parliamentary stages of the Health (Screening Programmes) Amendment Bill [recommendations 14, 16, 17 and 30 refer].

NZHIS NZHIS is responsible for managing a number of collections of health data. These include the New Zealand Cancer Register, the Mortality Collection and the National Health Index (NHI). NZHIS produces a number of publications relating to statistics on the incidence and mortality of cancer. There is considerable analytical capability within NZHIS as well as a core competence in data warehousing. NZHIS is participating in the audit of screening performance by supplying information requested by the Cancer Audit Project about cases of cervical cancer registered by the New Zealand Cancer Register. Prior to supply the data are subjected to rigorous examination, which in some cases includes consultation with pathologists and relevant healthcare providers. NZHIS has successfully met the deadlines required by the project so far.


8

Summary of the Implementation of the Cervical Screening Inquiry Recommendations in 2001/02 Audit of Invasive Cervical Cancer One of the key recommendations of the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region (the Inquiry) was an Audit of cases of invasive cervical cancer. The Audit will examine the screening histories of women diagnosed with cervical cancer to determine where improvements to the NCSP are needed. The Audit relates to a period in which the NCSP was not operating optimally and which was examined in detail by the Inquiry. The Audit is acknowledged as representing perhaps the largest and most complex of the projects to implement the Inquiry Recommendations. To ensure that the Audit would meet its objectives, considerable effort was expended during 2001/02 on the crucial set-up and design phases, including completion of Literature Research, Legal Review, Audit Framework, Detailed Audit Protocol, and testing of the New Zealand Cancer Register and NCSP-R data matching and extraction. Early in 2002, project sponsorship for the Audit changed and the project effectively moved out of the NSU, although remained within the Ministry. This was intended in part to provide some independence from the ongoing operational aspects of the NCSP and functions of the NSU. The Audit is now into Phase Four of its work, following the detailed design, development and planning work carried out throughout much of the year. A significant milestone, the obtaining of ethics committees� approval, was achieved in June 2002, allowing the Audit to proceed fully.

Ethics Progress to implement the Inquiry Recommendations regarding ethics committees was not straightforward. The Inquiry Report made five recommendations related to the operation of ethics committees (recommendations 18, 19, 20, 21, 22, 23). These recommendations as written were not specific to the NCSP but applied to the whole area of health and ethical review in New Zealand. Given that regional ethics committees in New Zealand are not established in legislation, it was necessary to find an appropriate vehicle for implementing the recommendations of the Inquiry. At the time the Inquiry Report was released, two methods were identified:

• through amendments to the National Standard, to which ethics committees are obliged to conform

• as part of the work of NEAC which was already planned to be set up under the New Zealand Public Health and Disability Act 2000.

At the time of the Inquiry Report, the National Standard for ethics committees had been under review. The opportunity was taken to incorporate the Inquiry


9

Recommendations within this review. The Health Research Council and Regional Ethics Committees, both users of the National Standard, were not in full agreement with the Inquiry Recommendations. There was difficulty in reaching agreement and as a result non-contentious changes would be made to the original 1996 Standard, and contentious issues would be referred to NEAC. The Minister of Health agreed to the incorporation of recommendations 19, 21, 22 and 23 into the terms of reference for NEAC. Following a process of public advertising and Cabinet approvals, membership of this committee was announced in December 2001. NEAC commenced meetings in April 2002. NEAC has developed a work programme that addresses the recommendations and it is consulting with the Ministry of Health on the timeframes and approach for carrying out the work.

Legislation The Government�s timeframe for the implementation of recommendations to deliver legislative change, originally proposed to take place before the end of 2001 was extremely tight. Initially referred to as the Comprehensive Bill, legislative change covered information sharing, complaints processes and safety and effectiveness and evaluation of the NCSP. Changes were required to the Injury Prevention Rehabilitation and Compensation Act 2001, the Health and Disability Services Commissioner Act 1994, the HPCA and the Health Act 1956. Policy work on the constituent parts was completed on time, but drafting of the legislation took longer than anticipated and this, coupled with the complex nature of the Bills themselves, resulted in the Comprehensive Bill eventually being split into its constituent parts. The Injury Prevention Rehabilitation and Compensation Act 2001 was enacted in April 2001. The amendments that were required to the Health and Disability Services Commissioner Act 1994 were incorporated into the HPCA. Amendments to the Health Act 1956 were separated out as the main Bill. Recommendation 29 referring to the amendments to the Medical Laboratory Technologists Regulations 1989 will be implemented through the enactment of the HPCA and the provisions that relate to scopes of practice.

The Health (Screening Programmes) Amendment Bill Because of the history of cervical screening, and in particular as a result of the report of the Ministerial Inquiry, there is a very high level of public interest in the effectiveness and safety of the NCSP. The Inquiry generated some very specific recommendations on changes needed to the legislative framework governing the operation and ongoing review of the NCSP. A key focus is to strengthen the provisions that provide for evaluators to rigorously review the safety of the NCSP and its component services. In this respect, the new Health (Screening Programmes) Amendment Bill will be an important statute for the enhancements it will bring to the safety and effectiveness of the NCSP. The Bill will assist in building and maintaining public confidence in health services generally and, in particular, the need for women to have confidence in the NCSP.


10

In addition to making provision for improved evaluation of the Programme, the Bill also allows for the making of regulations prescribing standards to be met by providers of screening and diagnostic and treatment services. At present there is no satisfactory way that standards can be made mandatory for non-contracted providers. This situation has been noted in several recent reports as a particular area of concern for the NCSP in relation to providers of smear-taking services, the large majority of which have no contractual relationship with the NCSP. The NSU played a key role in the development of the new Health (Screening Programmes) Amendment Bill. The Health (Screening Programmes) Amendment Bill received final Cabinet approval between 24 April and 13 May 2002 and was introduced to Parliament on 16 May 2002. The Bill received a category two priority from Cabinet on the legislative programme (must be passed this parliamentary year). However, this was anticipated by Cabinet when setting the interim legislation programme pending a general review. It was also noted by Cabinet, that because of the large volume of legislation brought forward from the last parliament and the limited House time for the remainder of 2002, many Bills would not make the progress in 2002 suggested by their priority descriptions. As of 21 October the Bill has commenced, but not yet completed its first reading in the House.

Kaitiaki Regulations Preparation of a discussion document on the review of the Kaitiaki Regulations was completed and distributed to up to 3000 people and organisations. Twelve regional hui took place between 12 March and 19 April. Following consultation with Maori women, Cabinet decided that the National Kaitiaki Group, would continue to consider all applications for access, use and publication of Maori women�s aggregate data on the NCSP-R and approve those applications that complied with the criteria described in the Kaitiaki Regulations. Processes for access to Maori women�s aggregate data will be improved for the NCSP so that the NCSP is better able to monitor, evaluate and audit the programme for the benefit of Maori women.

NCSP Operations Legal Review Recommendations 5 and 6 of the Inquiry Report called for a high level legal review of aspects of the NCSP. In June 2001, the NSU asked Kim Murray, Barrister, to carry out the legal review work. Mr Murray had previously represented the Health Funding Authority (HFA) and the Ministry at the Inquiry and was extremely knowledgeable of the NCSP and the complex issues that arose during the Inquiry. A report on his findings was provided to the NSU in December 2001.


11

The legal review provided an objective assessment of some of the important legal issues raised by the Inquiry. The legal review referred to the legal inadequacies that were of most concern to the Inquiry. These included those related to the monitoring and evaluation of the NCSP and the compulsory imposition of quality assurance processes. Ultimately these concerns were primarily related to the ability of the NCSP to operate in an optimally safe and effective manner and thus it was necessary for the legal review to focus on the vital issue of quality standards for the Programme. The legal review noted progress towards addressing some of the issues raised in the Inquiry Report, but some gaps were found in the legal authority to manage the Programme and ensure its safety. To overcome these deficiencies the legal review recommended that:

• the proposed Health (Screening Programmes) Amendment Bill as currently drafted should go further to enhance the safety of the Programme

• standards need to be legally binding on all providers (public and private) with the associated power to conduct monitoring

• the Programme must be more clearly established in law with the Director General of Health given wider statutory responsibility and authority over the Programme.

Provision of Statistical Information The 1996-98 NCSP Statistical Report was published and distributed to stakeholders in April 2002, and work on the 1999-2000 report commenced. Four NCSP Independent Monitoring Group (IMG) quarterly reports were published during the year. Good progress has been made on the routine monitoring of performance indicators across the programme, including laboratories. These reports were distributed to around 170 providers and stakeholders and are available on the screening programme�s website www.healthywomen.org.nz

NCSP Policy and Quality Standards Good progress was made in the implementation of recommendations relating to the introduction of policy and quality standards with community laboratories and DHB�s providing a colposcopy and NCSP regional service. The two public hospital laboratories providing cervical cytology services, however, struggled to meet the required minimum volume of cytology cases despite their best endeavours. The NSU continues to support the need to retain public hospital cytology services and improve cytology education/training and academic pathology opportunities. In the current training year (to December 2002) the two public hospital laboratories are contracted by the Ministry to train 21.5 full time equivalent registrars in pathology, representing 48.3 percent of the total training in pathology, including cytology in New Zealand. Generally


12

community laboratories do not have a direct contractual provision for the training of pathology registrars although some do provide this training on a subcontract basis with DHBs. The NSU is reviewing this situation further to determine whether there are opportunities in 2002/03 for increasing cytology test volumes at these laboratories, given their significant role in providing pathology training and education in New Zealand. Further work is needed with regard to implementation of standards for smear takers. The difficulties associated with the NSU implementing standards for smear takers were covered in some detail in the legal assessment provided to the Unit in response to recommendations 5 and 6. Further policy development work is required to examine the various options for implementing standards for smear takers.

NCSP Structure Recommendations relating to the structure of the NCSP were reported as complete in the Six-Month Summary Report and discussion followed within the body of the report highlighting how these recommendations had been implemented. The NSU was established in November 2000 as a separate business unit within the Public Health Directorate of the Ministry of Health. As a business unit the NSU has its own budget for the delivery of New Zealand�s two organised screening programmes. The Group Manager of the NSU has the delegated authority to manage the Unit, having due regard to Ministry policies and public sector rules and expectations regarding financial management, human resources, and use of capital and facilities management. The actual requirement for the NSU to have its own budget and contract directly with providers was largely implemented from 1 July 2001. Three new clinical leadership positions were created in 2001/02, namely the Public Health Leader Screening and Clinical Leader positions for each of the two programmes. Alongside recruitment to these positions, and in response to issues raised, the NSU commissioned a review of its organisation structure, specifically in relation to the requirement for clinical and public health leadership4. This review formed the basis of a facilitated �round table� discussion with key stakeholders. In summary the outcome of the review and �round table� discussion was as follows.

• Clinical leaders to be appointed for BSA and NCSP, with joint accountability with the incumbent Operational Managers of BSA and NCSP, and reporting to the NSU Group Manager.

• Public Health Leader Screening is to be appointed for the NSU, working alongside the incumbent NSU Group Manager and reporting to the Director of Public Health.

4 NSU, Organisation Structure Review, Project Report, Internal Review for the Ministry of Health, Downard Chadwick & Associates, June 2002.


13

Workforce Development Considerable work was completed by the NSU on the development of a Workforce Development Strategy (the Strategy), which was published in draft form in December 2001. A number of the Inquiry Recommendations relate directly or indirectly to the development of the screening workforce. Some recommendations refer to key policies and standards to be implemented by the NCSP providers, such as minimum volumes for laboratory staff screening cervical smears. Five of the recommendations (28, 29, 40, 41 and 42) relate to screening workforce development directly and the Strategy contains initiatives to address the issues raised.

Information to Women The NSU contracted Women�s Health Action Group to develop a new, more detailed booklet for women regarding the NCSP including the benefits and risks of screening and having a cervical smear. This detailed booklet was published in June 2002. A tear-off information sheet booklet on cervical screening was produced and distributed to general practitioners. Basic information about the NCSP for smear takers, gynaecologists and women is available through a range of pamphlets and brochures. These resources are distributed by the programme�s regional offices in correspondence with women and are available free of charge to practitioners through their local Health Education Provider. The NSU also has a user-friendly website www.healthywomen.org.nz as well as an 0800 number to give easy access to women.

Information Technology

NCSP-R and the New Zealand Cancer Register Link The NSU and the New Zealand Cancer Register agreed upon a regular data assurance process between the NCSP-R and the New Zealand Cancer Register to be performed monthly. This process has been refined and enhanced since the first trial in 2001. Within this process, the New Zealand Cancer Register reviews information it holds and is able to obtain missing data directly from the source laboratories rather than the NCSP-R to update and correct the New Zealand Cancer Register information. In addition, by checking all the cancers reported to the NCSP-R, the New Zealand Cancer Register is now able to inform the NSU which are primary cervical cancers, enabling this important information to be recorded in the NCSP-R. Further investigation has taken place into the requirements for automated electronic links between the NCSP-R and the New Zealand Cancer Register (referred to in previous monthly reports as Phase 2). No compelling requirements for automated electronic links, beyond those already successfully implemented, were identified. Phase 2 has therefore been discontinued. This decision was further reviewed in the development of the regular Monthly Data Assurance process. It has been agreed that this process has been automated, as far as is desirable because it is imperative that individual discrepancies are manually checked and agreement reached


14

on any corrections made. It is intended to give the New Zealand Cancer Register read-only access to the NCSP-R.

The New Zealand Cancer Register Information In essence the CSI report recommended that NZHIS should improve the currency of information about cervical cancer and generate meaningful statistics on a regular basis (recommendations 8 and 26). Provisional incidence statistics for 2001 were supplied to the NSU in April 2002 and posted on the NZHIS website. Registration of cases diagnosed up to June 2002 is complete. The New Zealand Cancer Register database was rebuilt in 2001 with the objective of providing improved functionality for data recording, data validation, and ad hoc reporting. Additional fields were included to enable recording of the name of the consultant healthcare provider; the tumour grade; and most importantly FIGO stage of disease classification. The inclusion of FIGO stage will enable much more detailed analysis of the extent of disease at the time of diagnosis. When linked to screening-history in routine audits FIGO stage will be a significant indicator of screening performance at a regional level.

Population Register NZHIS has initiated a project to create a population register for use in the health sector, based upon the NHI. Work has begun on establishing the user requirements for a population health register. In parallel with this process, work is continuing to improve the quality and coverage of the NHI system. The NHI currently covers approximately 98 percent of the New Zealand population in terms of registrations but is not configured in a way that would meet the needs of a population register for clinical use. The index is known to contain a number of duplicates, the majority of which date from the early days of the system. The work so far on the NHI has centred on addressing the duplicates from a data quality perspective and implementing technology and process changes to prevent the creation of duplicate registrations on an ongoing basis. An NHI duplicate resolution programme has been established. Already an average of four times as many duplicates per month are being found and addressed. NZHIS is in the process of employing additional resources to further increase the rate at which the remaining duplicates are found, with a view to resolving the bulk of the duplicates by June 2003. The requirements for a new user interface to the NHI for use by primary health care providers has been specified. Once developed, it is anticipated that the source code for the system will be made available to Patient Management Systems (PMS) vendors to enable them to upgrade their products.


15

A new name search engine has been purchased and is being installed. Prototype testing already indicates a significant improvement in search speed and accuracy will be achieved. Options for delivering new education and training required as a result of the technology improvements are being developed. It is intended that training will be delivered interactively through the Internet. Collectively, these improvements will result in a more accurate and up-to-date register of the population of health care users.

Implementation Summary 2001/02 A summary of the key milestones reached to implement the Inquiry Recommendations for 2001/02 is included in Table 2 below.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

16

Tabl

e 2.

0 Im

plem

enta

tion

Sum

mar

y

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

1.

Ev

alua

tion

of N

CSP

Th

e Ev

alua

tion

and

Follo

w-u

p of

Wom

en w

ith A

bnor

mal

Sm

ears

• U

nive

rsity

of

Ota

go c

ompl

eted

the

Rev

iew

of

Follo

w-u

p of

Wom

en w

ith A

bnor

mal

Sm

ears

in S

epte

mbe

r 01.

Audi

t of I

nvas

ive

Cer

vica

l Can

cer

• Ph

ase

1 co

mpl

eted

Sep

tem

ber 0

1.

• Et

hics

Com

mitt

ee A

pplic

atio

n Fe

brua

ry 0

2.

• M

ain

Audi

t Tea

m a

ppoi

ntm

ents

fina

lised

Mar

ch 0

2.

• Ph

ase

2 co

mpl

eted

Apr

il 02

.

• Ph

ase

3 co

mpl

eted

Jun

e 02

.

• Ph

ase

4 co

mm

ence

d.

• Ph

ase

5 co

mm

ence

d.

2.

R

e-en

rolm

ent a

nd re

-scr

eeni

ng o

f wom

en.

3.

C

ox�s

199

7 co

mpr

ehen

sive

eva

luat

ion

of t

he

NC

SP s

houl

d be

com

men

ced

with

in 1

8 m

onth

s.

• Pa

rts

5,

6 an

d 8

incl

uded

w

ithin

th

e sc

ope

of

Part

3 (C

ance

r Au

dit)

� se

e re

com

men

datio

n 1

abov

e.

• Pa

rts

4,

7 an

d 10

in

clud

ed

with

in

scop

e of

N

CSP

St

atis

tical

R

epor

ting

- se

e re

com

men

datio

n 7

belo

w.

4.

Im

plem

enta

tion

of

Ope

ratio

nal

Polic

y an

d Q

ualit

y St

anda

rds

& Ev

alua

tion

& M

onito

ring

Plan

.

• Im

plem

enta

tion

of

cont

ract

ually

bi

ndin

g po

licy

and

qual

ity

stan

dard

s fo

r he

alth

pr

omot

ion,

col

posc

opy,

labo

rato

ries

July

01.

• N

CSP

Ind

epen

dent

Mon

itorin

g G

roup

Mon

itorin

g Pl

an f

inal

ised

, in

clud

ing

natio

nal

indi

cato

rs fo

r per

form

ance

mon

itorin

g.

• Pu

blic

atio

n of

Inde

pend

ent M

onito

ring

Gro

up N

CSP

qua

rterly

mon

itorin

g re

ports

1, 2

, 3

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

17

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

and

4.

5.

Fu

ll le

gal a

sses

smen

t of O

pera

tiona

l Pol

icy

and

Qua

lity

Stan

dard

s.

• R

epor

t pro

vide

d to

NSU

in D

ecem

ber 2

001.

• Br

iefin

g pr

ovid

ed M

arch

02.

6.

Le

gal a

sses

smen

t of N

CSP

Aut

horit

y.

• R

epor

t pro

vide

d to

NSU

in D

ecem

ber 2

001.

• Br

iefin

g pr

ovid

ed M

arch

02.

7.

St

atis

tical

Rep

ortin

g.

• 19

96-9

8 R

epor

t Pub

lishe

d Ap

ril 0

2.

• W

ork

on th

e 19

99/0

0 re

port

com

men

ced.

8.

R

egul

ar S

tatis

tical

Info

rmat

ion.

R

egio

nal i

ncid

ence

of c

ance

r and

labo

rato

ry re

porti

ng ra

tes

• N

SU a

nd U

nive

rsity

of O

tago

con

side

red

deliv

ery

of a

spec

ts o

f thi

s re

com

men

datio

n no

t po

ssib

le, h

owev

er fu

rther

con

side

ratio

n is

bei

ng g

iven

to th

is re

com

men

datio

n.

The

New

Zea

land

Can

cer R

egis

ter R

equi

rem

ents

• Th

e N

ew Z

eala

nd C

ance

r R

egis

ter

data

base

was

reb

uilt

in 2

001

with

the

obj

ectiv

e of

pr

ovid

ing

impr

oved

fun

ctio

nalit

y.

Incl

usio

n of

the

FIG

O s

tage

will

enab

le m

uch

mor

e de

taile

d an

alys

is o

f the

ext

ent o

f the

dis

ease

at t

he ti

me

of d

iagn

osis

.

9.

M

inim

um

Volu

me

Stan

dard

s fo

r C

ytol

ogy

Labo

rato

ries.

•

DH

B an

d C

omm

unity

Lab

orat

ory

Agre

emen

ts in

corp

orat

e m

inim

um v

olum

e st

anda

rds

� Ju

l 01.

• Tw

o pu

blic

hos

pita

l pro

posa

ls re

ceiv

ed J

une

01.

• Pu

blic

Hos

pita

l lab

orat

orie

s st

rugg

le to

mee

t min

imum

vol

ume

stan

dard

s Ju

ne 0

2.

10.

Ba

lanc

ed A

ppro

ach

to N

CSP

.

11.

Pr

eser

vatio

n of

Jul

ia P

eter

�s c

ultu

re.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

18

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

12.

N

CSP

M

anag

ed

as

a se

para

te

unit

with

a

sepa

rate

bud

get.

• N

SU e

stab

lishe

d as

sep

arat

e bu

sine

ss u

nit w

ith re

spon

sibi

lity

for N

CSP

and

BSA

.

• Bu

dget

est

ablis

hed

and

effe

ctiv

e fro

m J

uly

01.

13.

N

CSP

to b

e co

ntro

lled

by 2

nd o

r 3rd

tier

man

ager

w

ith M

inis

try.

• N

SU m

anag

ed b

y 3rd

tier

man

ager

.

• O

rgan

isat

ion

stru

ctur

e re

view

of N

SU c

ompl

eted

May

02.

14.

Am

end

S74

of th

e H

ealth

Act

195

6.

• D

iscu

ssio

n do

cum

ent c

ompl

eted

Jun

e 01

.

• D

iscu

ssio

n do

cum

ent s

ubm

issi

ons

rece

ived

Jul

y 01

.

• Po

licy

wor

k co

mpl

eted

and

pap

er to

Cab

inet

Sep

t 01.

• PC

O In

stru

ctio

n an

d dr

aftin

g of

legi

slat

ion

com

plet

ed A

pril

02.

• C

abin

et L

egis

lativ

e C

omm

ittee

Apr

il 02

.

• In

trodu

ctio

n to

Hou

se M

ay 0

2.

15.

Ka

itiak

i Reg

ulat

ions

. •

Initi

al d

iscu

ssio

n do

cum

ent a

nd fo

cus

grou

p D

ecem

ber 0

1.

• D

iscu

ssio

n do

cum

ent c

ompl

eted

Feb

ruar

y 02

.

• C

onsu

ltatio

n H

ui c

ompl

eted

Apr

il 02

.

• Br

iefin

g to

Min

iste

r May

02.

• C

abin

et P

aper

Jun

e 02

.

16.

Le

gal r

ight

to

acce

ss in

form

atio

n fro

m t

he N

ew

Zeal

and

Can

cer R

egis

ter.

• R

efer

to 1

4 ab

ove.

17.

Am

end

Hea

lth A

ct 1

956

to e

nabl

e ac

cess

to

med

ical

file

s.

• R

efer

to 1

4 ab

ove.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

19

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

18.

C

hang

e gu

idel

ines

un

der-w

hich

et

hics

co

mm

ittee

s op

erat

e.

• C

onsu

ltatio

n of

dra

ft op

erat

iona

l gui

delin

es c

ompl

eted

Aug

ust 0

1.

• O

pera

tiona

l gui

delin

es fi

nalis

ed O

ctob

er 0

1.

19.

R

evie

w o

f ope

ratio

ns o

f eth

ics

com

mitt

ees.

•

Wor

k to

be

unde

rtake

n by

NEA

C.

20.

Pr

ovid

e gu

idel

ines

to

et

hics

co

mm

ittee

s re

gard

ing

Priv

acy

Act &

Cod

e.

• R

efer

to 1

8 ab

ove.

21.

G

uide

lines

to

et

hics

co

mm

ittee

s fo

r ob

serv

atio

nal s

tudi

es.

• W

ork

to b

e un

derta

ken

by N

EAC

.

22.

N

atio

nal e

thic

s co

mm

ittee

� m

ulti-

cent

re s

tudi

es.

• W

ork

to b

e un

derta

ken

by N

EAC

.

23.

Ap

peal

pro

cess

for e

thic

s co

mm

ittee

dec

isio

ns.

• W

ork

to b

e un

derta

ken

NEA

C.

24.

N

CSP

Com

plai

nts

Syst

em.

• Ph

ase

1 co

mpl

eted

Jun

e 02

.

25.

El

ectro

nic

Link

be

twee

n th

e N

ew

Zeal

and

Can

cer R

egis

ter &

the

NC

SP-R

•

Proc

esse

s fo

r lin

king

and

mat

chin

g da

ta im

plem

ente

d N

ovem

ber 0

1.

26.

Pe

rform

ance

Sta

ndar

ds f

or N

CSP

-R a

nd t

he

New

Zea

land

Can

cer R

egis

ter.

• Th

e N

ew Z

eala

nd C

ance

r Reg

iste

r Reb

uild

com

plet

ed J

une

02.

• N

CSP

-R w

ork

to c

omm

ence

in 0

2/03

.

27.

St

anda

rds

for

the

NC

SP s

houl

d be

rev

iew

ed

ever

y tw

o ye

ars.

•

To c

omm

ence

in 0

2/03

.

28.

Th

e G

over

nmen

t m

ust

ensu

re

suffi

cien

t cy

tote

chno

logi

sts

and

cyto

path

olog

ists

an

d tra

inin

g si

tes.

• R

esea

rch

repo

rt co

mpl

eted

Aug

ust 0

1.

• W

orkf

orce

Sur

vey

com

plet

ed O

ctob

er 0

1.

• W

orkf

orce

Dev

elop

men

t Stra

tegy

Com

plet

ed D

ecem

ber 0

1.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

20

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

• Im

plem

enta

tion

plan

pre

pare

d.

• Fu

nds

iden

tifie

d fo

r ope

ratio

nal a

nd s

ervi

ce p

urch

asin

g.

29.

Am

end

Med

ical

La

bora

tory

Te

chno

logi

sts

Reg

ulat

ions

198

9.

• R

efer

to 3

4 be

low

.

30.

Im

pose

Leg

al o

blig

atio

ns o

n st

orag

e of

slid

es.

• R

efer

to 1

4 ab

ove.

31.

En

sure

el

ectro

nic

linka

ge

betw

een

NC

SP

Reg

iste

r and

Cyt

olog

y La

bs.

• M

igra

tion

of N

CSP

-Reg

iste

r to

Hea

lth In

trane

t com

plet

e.

32.

D

evel

op S

tand

ards

for

acc

urac

y of

lab

orat

ory

codi

ng.

• To

com

men

ce 2

002/

03.

33.

Th

e N

CSP

sho

uld

deve

lop

a po

pula

tion-

base

d re

gist

er.

• Th

e N

SU is

repr

esen

ted

on th

e M

inis

try�s

Pop

ulat

ion

Reg

iste

r Pro

ject

led

by N

ZHIS

.

34.

Le

gal m

echa

nism

s sh

ould

be

in p

lace

to

allo

w

the

ACC

, M

edic

al C

ounc

il an

d th

e H

ealth

&

Dis

abilit

y C

omm

issi

oner

to

sh

are

rele

vant

in

form

atio

n w

ith th

e M

inis

try�s

NC

SP.

• Po

licy

fram

ewor

k pa

per c

ompl

eted

May

01.

• C

ompl

aint

s pa

per c

ompl

eted

Aug

ust 2

001.

• PC

O In

stru

ctio

n an

d fin

al d

rafti

ng o

f leg

isla

tion

com

plet

ed S

epte

mbe

r 01.

• C

abin

et L

egis

lativ

e C

omm

ittee

Jun

e 02

.

• In

trodu

ctio

n to

Hou

se J

une

02.

35.

M

edic

al T

ribun

al to

sup

ply

info

rmat

ion

to N

CSP

. •

Ref

er to

34

abov

e.

36.

AC

C

& M

edic

al

Cou

ncil

shou

ld

exch

ange

re

leva

nt in

form

atio

n re

gard

ing

clai

ms

for m

edic

al

mis

adve

ntur

e.

• R

oyal

ass

ent r

ecei

ved

for I

njur

y Pr

even

tion

and

Reh

abilit

atio

n Bi

ll �

to c

ome

into

effe

ct

April

02.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

21

Ref

. R

ecom

men

datio

n 20

01/0

2 Im

plem

enta

tion

37.

Li

aiso

n w

ith R

oyal

Col

lege

of P

atho

logi

sts

• O

ngoi

ng.

38.

In

form

atio

n to

Wom

en.

• N

ew C

olpo

scop

y br

ochu

re J

uly

01.

• Te

ar-o

ff bo

okle

t for

GPs

pub

lishe

d M

ay 0

2.

• D

etai

led

book

let p

ublis

hed

June

02.

39.

Le

tters

to M

edic

al P

ract

ition

ers.

•

Lette

r sen

t Dec

embe

r 01.

40.

Ap

prop

riate

ly

train

ed

pers

onne

l sh

ould

do

ce

rvic

al s

cree

ning

. •

Ref

er to

28

abov

e.

41.

Al

l pat

holo

gist

s un

derta

king

cyt

olog

y sh

ould

be

appr

opria

tely

trai

ned.

•

Ref

er to

28

abov

e.

42.

C

ytop

atho

logi

sts

mus

t pa

rtici

pate

in

cont

inui

ng

educ

atio

n in

cyt

opat

holo

gy.

• R

efer

to 2

8 ab

ove.

43.

Pa

thol

ogis

ts o

ught

to b

e m

ore

open

-min

ded.

44.

Th

e M

edic

al C

ounc

il sh

ould

ens

ure

that

sys

tem

s ar

e in

pla

ce t

o su

ppor

t th

e ea

rly r

epor

ting

of

erra

nt m

edic

al p

ract

ition

ers

by th

eir c

olle

ague

s.

• R

efer

to 3

4 ab

ove.

45.

N

CSP

sh

ould

ha

ve

a sy

stem

fo

r id

entif

ying

de

ficie

ncie

s.

• R

efer

to 2

4 ab

ove.

46.

Th

ere

shou

ld b

e a

proc

ess

for

mon

itorin

g th

e im

plem

enta

tion

of

the

Com

mitt

ees

Rec

omm

enda

tions

.

• D

r McG

ooga

n�s

Six-

Mon

th R

epor

t rel

ease

d Fe

brua

ry 0

2.


22

Six Month Review Six months following the release of the Inquiry Report, two reviews on progress to implement the Inquiry Recommendations were completed. 1. Progress in Implementing the Cervical Screening Inquiry

Recommendations: Independent Report Dr Euphemia McGoogan, expert cytopathologist and advisor to Minister of Health, December 2001.

2. Report of the Controller and Auditor-General: Ministry of Health: Progress in Implementing the Recommendations of the Cervical Screening Inquiry. Office of the Controller and Auditor-General, February 2002.

In response to recommendation 46 of the Inquiry Report, expert cytopathologist Dr Euphemia McGoogan was engaged by the Minister of Health to provide independent advice on progress to implement the Inquiry Recommendations. Dr McGoogan visited New Zealand for 10 days in October/November 2001 to carry out a review of progress over the first six months. This visit included meetings with over 100 individuals in around 35 separate meetings. To assist Dr McGoogan in her review, the Ministry also supplied full documentation on activity to deliver the Inquiry Recommendations. A written report summarising her findings was provided to the Minister on 16 December 2001. Dr McGoogan also completed a 12-Month visit in April 2002. In October 2001 the OAG wrote to the Director-General advising her that the OAG intended to carry out a short piece of work to determine what action had been taken to implement the Inquiry Recommendations. A final draft of their report was provided to the Ministry on 30 January 2002. In her six-month report, Dr McGoogan made particular mention of the assistance she received to complete her review. She was satisfied that she was able to have frank and open discussion with the groups and individuals with whom she met and noted the immense volume of information obtained during her visit, only six months after the release of the Inquiry Report. The OAG found that good progress had been made in setting up structures and systems to address the Inquiry Recommendations. The OAG commented that in the course of its review the Office saw evidence of much determination - particularly among Ministry staff responsible for the programme - that the mistakes of the past would not be repeated again and that recommended changes to the programme would be made5. Dr McGoogan acknowledged the tremendous effort made by the NSU into improving the quality of the NCSP at all levels. She acknowledged the commitment, enthusiasm and dedication of the staff of the Unit and the efforts made to improve the NCSP despite a shortfall in staff.

5 Office of the Controller and Auditor �General. February 2002. Report of the Controller and Auditor �General: Ministry of Health: Progress in Implementing the Recommendations of the Cervical Screening Inquiry. Wellington: Office of the Controller and Auditor Genera. Page 9.


23

Both the OAG and Dr McGoogan concluded that good progress has been made on implementing quality standards and routine monitoring of performance indicators across the NCSP, including laboratories. Both Dr McGoogan and the OAG did express concerns regarding progress on several recommendations including:

• progress on the Audit of Invasive Cervical Cancer

• the ability to implement recommendations related to ethics committees

• the extended time taken to implement new legislation and the inability through the consultation processes to deliver all of the CSI recommendations fully

• the capacity and capability of the NSU.

As part of her review, Dr McGoogan also made a further 24 recommendations for improvements to the NCSP. Of these 24 recommendations, 10 related to workforce issues, five related to laboratory coding and reporting, and others related to information systems, monitoring, NCSP regional offices, and provision of information to NCSP participants. This brought the total number of recommendations from the Inquiry and Dr McGoogan to 70. The breadth of these recommendations ranged from relatively small operational improvements to broad organisational requirements, and to those requiring wider sector and Government action. All recommendations were incorporated into the NSU�s detailed work plan. Of the 37 Recommendations reported as under way by the Ministry in its Six-Month Summary Report, 16 were reported as On-Track and 21 as having Revised Delivery Dates6. Dr McGoogan was disappointed that revised timelines were required for 21 of the recommendations. She was satisfied that sufficient progress has been made on the implementation of 16 recommendations. She was not satisfied that sufficient progress had been made on 4 of the recommendations with revised delivery dates and on 7 of the 16 recommendations reported as On-Track.

6 Revised Delivery Dates refer to amendments to the original timetable proposed by the Ministry in April 2001 rather than any timeframes as may have been specified within the Inquiry Report.


24

Financial Table 3.0 below summarises expenditure on delivery of the Inquiry Recommendations against the CSI Cost Centre. Some further expenditure was allocated to NSU budgets and not accounted for against the CSI Cost Centre.

Table 3.0 Total CSI Expenditure

2001/02 Baseline

2001/02 Actual7

General 263,407

Cancer Audit 525,855

Legislation 110,948

Ethics 2,284

Legal Assessment 48,517

Statistical Reports 8,369

Policy & Stds Implementation 72,808

Complaints System 23,198

Workforce Development 150,986

Information to Women 4,622

NZHIS 800,000

CSI 3,467,000 2,020,631

7 Some expenditure not accounted for in CSI budget, but coded to NSU NDOC


25

Issues/Risks 2002/03

Audit of Invasive Cervical Cancer The Inquiry and Dr McGoogan, have set out an expectation that the Audit will be the primary mechanism to reassure women that the NCSP today is �safe and effective�, and that until the findings of the Audit are known, these assurances cannot be given. The overall goal of the audit is to provide information to support improvements to the NCSP and thus contribute to a reduction in New Zealand women�s incidence and mortality from invasive cervical cancer. It will be important for the NCSP to liaise closely with the audit team to ensure any areas of the programme requiring improvement that are identified via the audit are actioned as early as possible. To facilitate this, the Clinical Leader of the NCSP will liaise with the audit team and be a member of the audit multidisciplinary advisory and liaison group. An effective communications strategy will be implemented to ensure the stakeholders and the public are informed of the findings of the Audit and how they relate to the NCSP today. Other means of ensuring the programme is operating effectively will also be undertaken by NCSP and communicated, and more work needs to take place in this area.

Ethics The National Ethics Advisory Committee will need to take a consultative approach to the work programme. This will be time consuming and it is unlikely to complete its proposed work programme until November 2003.

The Health (Screening Programmes) Amendment Bill (S74A of the Health Act 1956) As of 9 September the Bill has been allocated a category two priority for the 2002 parliamentary calendar. This priority indicates that the Bill is required to be passed this year. However, this was anticipated by Cabinet when setting the interim legislation programme pending a general review. It was also noted by Cabinet, that because of the large volume of legislation brought forward from the last parliament and the limited House time for the remainder of 2002, many Bills would not make the progress in 2002 suggested by their priority descriptions. Key issues centre on the timing of progress with and content of the Bill. It is estimated that the NSU will need in the order of 6 � 9 months after enactment to prepare for the full implementation of the new legislation. Anything other than speedy passage will require the commencement date to be extended beyond July 2003 as currently envisaged. The Bill includes provisions that are potentially controversial and it is possible that these (or other) provisions could be changed as part of the parliamentary process. The Ministry�s role is limited to advising the Select Committee and


26

the Minister on any amendments that might arise. Any amendments that might be made to the Bill would need to be carefully considered in terms of their implications for the NCSP.

NCSP Operations

Legal Review The NSU is undertaking a further legal review of the roles and responsibilities of the NCSP and its contracted providers. In particular the legal review will look at professional boundary and responsibility issues that exist between the NSU, NCSP regional services and clinical providers (both public and private), with particular reference to current practice and the stated role of the NCSP in providing a �back up� service for women.

Policy and Quality Standards Over the past year the two public hospital laboratories providing a cytology service to the NCSP have not obtained the minimum volume of 15,000 cytology smears per annum. Over the next year these two laboratories will need to continue their efforts to achieve this requirement.

A review of the colposcopy chapter of the Interim Operational and Policy and Quality Standards October 2000, and development of new NCSP Regional Office policy and quality standards will require extensive consultation. The review of the colposcopy chapter will include reviewing the minimum volume and requiring a colposcopist to undertake 100 new colposcopies annually.

The inability to enforce standards with smear takers continues to be of concern to the NSU. During 2002/03 the NSU will review options to ensure compliance of smear takers with the NCSP policy and quality standards.

Workforce Development Funding for 2002/03 to implement the Workforce Development Strategy has enabled priority projects that relate to laboratory workforce to be progressed. The implementation of initiatives for the development of the laboratory workforce requires cooperation between the laboratory sector and the NSU.

Information Technology

NCSP-R and the New Zealand Cancer Register Link The successful migration of the NCSP-R on to the Health Intranet has laid the groundwork for the New Zealand Cancer Register to establish a read-only link to the NCSP-R. This will allow appropriately authorised staff to view the data on the NCSP-R and improve the existing data quality assurance processes. Central to the success of this is the ongoing operation of the Health Intranet and its components. Although there is a current issue around the certificating authority for the Health Digital Certificates, it is expected that this will be resolved without any interruption of service to current and intending users.


27

The issues resolution is being led within the Ministry of Health from within the Corporate and Information Directorate.

Population Register

Work has commenced within the NZHIS-led project to define the user requirements and agree the key deliverables for a population register. It is anticipated that the first key deliverable will be met in June 2003 with the establishment of a population denominator for the NHI. There is also other work ongoing to improve the NHI, which will also form the basis of the population register. The NSU is a key business owner for the project.

Areas beyond the technology component that still need to be addressed in substance from this project include governance, legislation, privacy, communication, and education. As these issues are addressed, further issues may arise that impact on the timely delivery of this project.

NZ Context for Screening International experts - Dr McGoogan and Professor Chamberlain, in their recent reviews of the NCSP and BSA respectively, have reflected on the difficulties in implementing organised screening programmes in New Zealand. These difficulties relate in part to the structure of the health sector, which includes both private and public service provision along the screening pathway. In addition, both experts commented that privacy concerns regarding the use of population registers for inviting individuals to participate in screening programmes, and regarding the use of data for evaluation, actually lessened the public�s chances of benefiting from preventative services. These difficulties were made very apparent in the work on new legislation for the NCSP and in the inability to implement and monitor standards in primary care. The NSU is participating in the Ministry of Health�s project to develop a population register for New Zealand, based upon the NHI. Clearly this project will benefit many areas of the health sector and public health programmes. Policy issues may present themselves as the register develops, given privacy concerns in New Zealand, presenting difficulties for the register project quite apart from any information systems development issues.


28

Summary of 2002/03 Plan A summary of the Implementation Plan for 2002/03 including key milestones is provided in Table 4.0 In 2002/03 emphasis will be on the following activities:

• the Audit of Invasive Cancer Phases 4 to 6

• implementation of direct NCSP laboratory agreements

• introduction of new legislation

• improvements to the NCSP-R

• laboratory workforce initiatives

• population register development

• development of NCSP provider audit tools. Many of the 2002/03 implementation activities now form part of the NSU�s ongoing core business, including:

• publication of regular quarterly monitoring reports

• publication of annual statistical reporting

• ongoing development and implementation of policy and standards

• ongoing development of health promotion resources

• liaison with Colleges and other professional organisations

• sharing of information with Accident Compensation Corporation, the Health and Disability Commissioner and the Medical Council of New Zealand

• NCSP-R and the New Zealand Cancer Register data assurance processes.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

29

Tabl

e 4.

0 Su

mm

ary

Impl

emen

tatio

n Pl

an 2

002/

03

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

1.

Ev

alua

tion

of N

CSP

. Au

dit o

f Inv

asiv

e C

ervi

cal C

ance

r

• Ph

ase

4 (c

onta

ctin

g an

d in

terv

iew

ing

wom

en) o

ngoi

ng.

• Ph

ase

5 (in

form

atio

n co

llect

ion)

ong

oing

.

• Ph

ase

6 (s

lide

revi

ew) t

o be

impl

emen

ted.

2.

R

e-en

rolm

ent a

nd re

-scr

eeni

ng o

f wom

en.

3.

C

ox�s

199

7 co

mpr

ehen

sive

eva

luat

ion

of t

he

NC

SP s

houl

d be

com

men

ced

with

in 1

8 m

onth

s.

• Pa

rts

5,

6 an

d 8

incl

uded

w

ithin

th

e sc

ope

of

Part

3 (C

ance

r Au

dit).

(S

ee

reco

mm

enda

tion

1abo

ve).

• Pa

rts 4

, 7

and

10 i

nclu

ded

with

in s

cope

of

NC

SP S

tatis

tical

Rep

ortin

g. (

Ref

er t

o re

com

men

datio

n 7

belo

w).

4.

Im

plem

enta

tion

of

Ope

ratio

nal

Polic

y an

d Q

ualit

y St

anda

rds

& Ev

alua

tion

& M

onito

ring

Plan

.

• Pu

blic

atio

n of

Inde

pend

ent M

onito

ring

Gro

up N

CSP

qua

rterly

mon

itorin

g re

ports

5, 6

, 7

and

8.

• Pu

blic

atio

n of

IMG

Ann

ual M

onito

ring

Rep

ort 2

001.

• Pu

blic

atio

n of

NC

SP &

BSA

Qua

lity

Fram

ewor

k.

• R

evie

w

of

optio

ns

to

man

date

st

anda

rds

for

NC

SP

Prov

ider

s.

(Ref

er

also

to

re

com

men

datio

n 14

bel

ow).

5.

Fu

ll le

gal a

sses

smen

t of O

pera

tiona

l Pol

icy

and

Qua

lity

Stan

dard

s.

• Fu

rther

le

gal

asse

ssm

ent

of

NC

SP

prac

titio

ner�s

re

spon

sibi

litie

s,

incl

udin

g N

CSP

R

egio

nal O

ffice

s.

6.

Le

gal a

sses

smen

t of N

CSP

Aut

horit

y.

• R

efer

to re

com

men

datio

n 14

bel

ow.

7.

St

atis

tical

Rep

ortin

g.

• 19

99-0

0 R

epor

t Pub

lishe

d.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

30

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

8.

R

egul

ar S

tatis

tical

Info

rmat

ion.

•

Ong

oing

.

9.

M

inim

um

Volu

me

Stan

dard

s fo

r C

ytol

ogy

Labo

rato

ries.

•

Ong

oing

.

10.

Ba

lanc

ed A

ppro

ach

to N

CSP

. •

Ong

oing

.

11.

Pr

eser

vatio

n of

Jul

ia P

eter

s C

ultu

re.

• O

ngoi

ng.

12.

N

CSP

M

anag

ed

as

a se

para

te

unit

with

a

sepa

rate

bud

get.

• Im

plem

enta

tion

of d

irect

NC

SP L

abor

ator

y Ag

reem

ents

.

13.

N

CSP

to

cont

rolle

d by

2nd

or

3rd t

ier

man

ager

w

ith M

inis

try.

• O

ngoi

ng.

14.

Am

end

S74

of th

e H

ealth

Act

195

6.

• H

ealth

(Scr

eeni

ng p

rogr

amm

es) A

men

dmen

t Bill

o

Firs

t Rea

ding

.

o

Sele

ct C

omm

ittee

.

o

Seco

nd R

eadi

ng.

o

Com

mitt

ee o

f Who

le H

ouse

.

o

Enac

tmen

t.

o

Impl

emen

tatio

n Pl

an.

o

Com

mun

icat

ions

Stra

tegy

o

Rev

ise

NC

SP In

form

atio

n to

Wom

en a

nd p

ract

ition

ers

reso

urce

s.

15.

Ka

itiak

i Reg

ulat

ions

. •

Impl

emen

t im

prov

ed p

roce

sses

.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

31

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

16.

Le

gal r

ight

to

acce

ss in

form

atio

n fro

m t

he N

ew

Zeal

and

Can

cer R

egis

ter.

• R

efer

to re

com

men

datio

n 14

abo

ve.

17.

Am

end

Hea

lth A

ct 1

956

to e

nabl

e ac

cess

to

med

ical

file

s.

• R

efer

to re

com

men

datio

n 14

abo

ve.

18.

C

hang

e gu

idel

ines

un

der-w

hich

et

hics

co

mm

ittee

s op

erat

e.

• Im

plem

ente

d.

19.

R

evie

w o

f ope

ratio

ns o

f eth

ics

com

mitt

ees.

•

Wor

k to

be

unde

rtake

n by

NEA

C.

20.

Pr

ovid

e gu

idel

ines

to

et

hics

co

mm

ittee

s re

gard

ing

Priv

acy

Act &

Cod

e.

• R

efer

to re

com

men

datio

n 18

abo

ve.

21.

G

uide

lines

to

et

hics

co

mm

ittee

s fo

r ob

serv

atio

nal s

tudi

es.

• W

ork

to b

e un

derta

ken

by N

EAC

.

22.

N

atio

nal e

thic

s co

mm

ittee

� m

ulti-

cent

re s

tudi

es.

• W

ork

to b

e un

derta

ken

by N

EAC

.

23.

Ap

peal

pro

cess

for e

thic

s co

mm

ittee

dec

isio

ns.

• W

ork

to b

e un

derta

ken

by N

EAC

.

24.

N

CSP

Com

plai

nts

Syst

em.

• N

ew In

form

atio

n Sy

stem

s in

pla

ce.

• M

OU

with

AC

C, H

DC

, Med

ical

Cou

ncil

in p

lace

.

25.

El

ectro

nic

Link

th

e N

ew

Zeal

and

Can

cer

Reg

iste

r & N

CSP

-R

• O

ngoi

ng.

26.

Pe

rform

ance

Sta

ndar

ds f

or N

CSP

-R a

nd t

he

New

Zea

land

Can

cer R

egis

ter.

• O

ngoi

ng.

• N

CSP

-R w

ork

to c

omm

ence

in 0

2/03

.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

32

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

27.

St

anda

rds

for

the

NC

SP s

houl

d be

rev

iew

ed

ever

y tw

o ye

ars.

•

Rev

iew

of C

olpo

scop

y St

anda

rds.

• R

evie

w o

f Reg

iona

l Offi

ce S

tand

ards

.

• R

evie

w o

f NC

SP S

mea

r Tak

er M

anag

emen

t Rep

orts

.

28.

Th

e G

over

nmen

t m

ust

ensu

re

suffi

cien

t cy

tote

chno

logi

sts

and

cyto

path

olog

ists

an

d tra

inin

g si

tes.

• La

bora

tory

Wor

kfor

ce A

dvis

ory

Gro

up.

• La

bora

tory

Wor

kfor

ce O

ptio

ns R

evie

w.

• La

bora

tory

Orie

ntat

ion

and

Supe

rvis

ion

Proj

ect.

• M

ore

BMLS

c St

uden

ts.

• Su

ppor

t for

the

NZ

Soci

ety

of C

ytol

ogy

Con

fere

nce.

29.

Am

end

Med

ical

La

bora

tory

Te

chno

logi

sts

Reg

ulat

ions

198

9.

• Ad

dres

sed

thro

ugh

scop

es o

f pra

ctic

e fo

llow

ing

the

impl

emen

tatio

n of

the

HPC

A.

30.

Im

pose

Leg

al o

blig

atio

ns o

n st

orag

e of

slid

es.

• R

efer

to re

com

men

datio

n 14

abo

ve.

31.

En

sure

el

ectro

nic

linka

ge

betw

een

NC

SP

Reg

iste

r and

Cyt

olog

y La

bs.

• La

bora

tory

link

age

to h

ealth

intra

net.

32.

D

evel

op S

tand

ards

for

acc

urac

y of

lab

orat

ory

codi

ng.

• Ad

ditio

n of

new

SN

OM

ED c

odes

.

• In

trodu

ctio

n of

Bet

hesd

a 20

01 c

odes

.

33.

Th

e N

CSP

sho

uld

deve

lop

a po

pula

tion-

base

d re

gist

er.

• Th

e N

SU is

rep

rese

nted

on

the

Min

istry

�s P

opul

atio

n R

egis

ter

Proj

ect l

ed b

y N

ZHIS

�

ongo

ing.

34.

Le

gal m

echa

nism

s sh

ould

be

in p

lace

to

allo

w

the

ACC

, M

edic

al C

ounc

il an

d th

e H

ealth

&

Dis

abilit

y C

omm

issi

oner

to

sh

are

rele

vant

in

form

atio

n w

ith th

e M

inis

try�s

NC

SP.

• Pr

ovis

ions

Incl

uded

in th

e H

ealth

Pra

ctiti

oner

s C

ompe

tenc

e As

sura

nce

Bill

• Fi

rst R

eadi

ng.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

33

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

• R

efer

ral t

o Se

lect

Com

mitt

ee O

ctob

er 2

002

(sub

mis

sion

s cl

ose

27 N

ovem

ber 2

002)

.

• Se

cond

Rea

ding

.

• Th

ird R

eadi

ng.

• C

omm

ittee

of W

hole

Hou

se.

• C

omin

g in

to fo

rce,

six

mon

ths

afte

r bei

ng p

asse

d.

35.

M

edic

al

Prac

titio

ners

D

isci

plin

ary

Trib

unal

to

su

pply

info

rmat

ion

to N

CSP

. •

Ref

er to

34

abov

e.

36.

AC

C

& M

edic

al

Cou

ncil

shou

ld

exch

ange

re

leva

nt in

form

atio

n re

gard

ing

clai

ms

for m

edic

al

mis

adve

ntur

e.

• Im

plem

ente

d.

37.

Li

aiso

n w

ith R

oyal

Col

lege

of P

atho

logi

sts.

•

Ong

oing

.

38.

In

form

atio

n to

Wom

en.

• D

evel

opm

ent o

f new

Hea

lth P

rom

otio

n St

rate

gy.

• R

evie

w M

aori

& Pa

cific

Res

ourc

es.

39.

Le

tters

to M

edic

al P

ract

ition

ers.

•

Ong

oing

.

40.

Ap

prop

riate

ly

train

ed

pers

onne

l sh

ould

do

ce

rvic

al s

cree

ning

. •

Ref

er to

28

abov

e.

41.

Al

l pat

holo

gist

s un

derta

king

cyt

olog

y sh

ould

be

appr

opria

tely

trai

ned.

•

Ref

er to

28

abov

e.

42.

C

ytop

atho

logi

sts

mus

t pa

rtici

pate

in

cont

inui

ng

educ

atio

n in

cyt

opat

holo

gy.

• R

efer

to 2

8 ab

ove.

CSI

Ann

ual R

evie

w 2

001/

200

2 an

d An

nual

Pla

n 20

02/0

3

N

ovem

ber 2

002

34

Ref

. R

ecom

men

datio

n 20

02/0

3 Pl

an

43.

Pa

thol

ogis

ts o

ught

to b

e m

ore

open

-min

ded.

44.

Th

e M

edic

al C

ounc

il sh

ould

ens

ure

that

sys

tem

s ar

e in

pla

ce t

o su

ppor

t th

e ea

rly r

epor

ting

of

erra

nt m

edic

al p

ract

ition

ers

by th

eir c

olle

ague

s.

• R

efer

to 3

4 ab

ove.

45.

N

CSP

sh

ould

ha

ve

a sy

stem

fo

r id

entif

ying

de

ficie

ncie

s.

• D

evel

opm

ent

of N

CSP

Aud

it Fr

amew

ork

and

Tool

s an

d co

mm

ence

men

t of

Pro

vide

r Au

dits

.

• M

anag

emen

t of N

CSP

Issu

es R

egis

ter.

46.

Th

ere

shou

ld b

e a

proc

ess

for

mon

itorin

g th

e im

plem

enta

tion

of

the

Com

mitt

ee�s

R

ecom

men

datio

ns.

• O

ngoi

ng


35

A further 24 recommendations for improvements to the NCSP were made by Dr Euphemia McGoogan as a result of her six month review visit in October/ November 2001 and subsequent report in December 2001. The recommendations are summarised below and form part of the 2002/2003 implementation plan.

Table 5.0 Dr McGoogan Recommendations

Ref. Recommendation 2002/03 Plan

1. Regional Offices. • Interim reconfiguration of Regional Office Register Operations.

2. Smear takers. • Smear taker training fund

• NCSP communication ongoing

• Update smear taker training courses offered.

3. CSI Report published in hardcopy form.

• Printed and distributed April 02.

4. Clinical Director input to teleconferences.

• Ongoing, NCSP Clinical Leader

5. Training programme & quality standards for staff reading liquid based cervical preparations.

• Detailed Review Chapter 5 - Providing a Laboratory Service (planned 03/04).

(Refer also to recommendation 27 of the Inquiry Recommendations).

6. Development of New Zealand EQA Scheme.

• Workforce Development Project initiative.

• Included in the detailed review of Chapter 5 of the NCSP Operational Policy and Quality Standards (planned 03/04).


7. Regular Cytology update courses. • Sponsorship of Annual Society of Cytology Conference.

• Included in the detailed review of Chapter 5 of the NCSP Operational Policy and Quality Standards (planned 03/04).


8. NSU Organisational Development.

• Ongoing

9. Significance abnormal smear results and colposcopy information for women.

• Colposcopy pamphlet printed June 2001


36


10. Send interim NCSP information leaflet pads to providers.

• Sent to providers May 2002

11. Standardised criteria for reporting unsatisfactory smears.

• Bethesda 2001 project. (See also recommendation 32 of the Inquiry Recommendations).

12. Issue guidance to labs about implementation of Bethesda 2001.

• Bethesda 2001 project. (See also recommendation 32 of the Inquiry Recommendations).

13. Identify duplicate additional smears at colposcopy.

• Colposcopy Policy and Standards review. (Refer also to recommendation 27 of the Inquiry Recommendations).

14. Short-interval re-screening � important to define who is being screened by each laboratory and how often.

• Short-interval re-screening analysis underway.

15. Audit of laboratory returns including �opt-off�.

• Health (Screening Programmes) Amendment Bill � Implementation project. (Refer also to recommendations 14, 16, 17, 30 of the Inquiry Recommendations).

16. Recording of conventional smears and thin prep samples on NCSP-Register.

• To be implemented

17. Additional SNOMED codes on NCSP Register.

• SNOMED coding project. (Refer also to recommendation 32 of the Inquiry Recommendations).

18. Inclusion of Colposcopy Data on the NCSP-Register.

• Health (Screening Programmes) Amendment Bill � Implementation project. (Refer also to recommendations 14, 16, 17, 30 of the Inquiry Recommendations).

• Colposcopy Policy and Standards Review (Refer also to recommendation 27 of the Inquiry Recommendations).

19. Improved communication between IMG, providers and NSU.

• Ongoing

20. Direct access to NCSP-Register for Labs.

• Ongoing

21. Improved information on NCSP laboratory referral form from smear-takers to laboratories.

• Review of electronic smear-taker forms

22. Role of regional office in relation to repeat smears for individual women.

• Legal review of roles and responsibilities. (Refer also to recommendations 5 and 6 of the Inquiry Recommendations).


37


23. 14 regional offices is an inefficient use of resources.

• Regional Office reconfiguration project.

• Legal review of roles and responsibilities. (Refer also to recommendations 5 and 6 of the Inquiry Recommendations.

24. Standards for smear takers and compliance cost issues.

• Ongoing

• Review of electronic smear-taker forms

• Health (Screening Programmes) Amendment Bill � Implementation project (Refer also to recommendations 14, 16, 17 and 30 of the Inquiry Recommendations).

25. Participation in the NCSP must be further improved.

• Continued work with the NCSP Regional

Offices and Independent Service

Providers on Health Promotion Plans with

the aim to improve coverage and

participation.

• Reducing Inequalities project

• Review and ongoing development of

NCSP Resources for women. (Refer also

to recommendation 38 of the Inquiry

Recommendations).


38

2002/03 Budget Table 6.0 below summarises expenditure on delivery of the Inquiry Recommendations against the CSI Cost Centre. Actual figures for 2001/02 are provided in column 1, the budgeted figures for 2002/03 are contained in column 2.

Table 6.0 Total CSI Budget

2001/02 Actual8 2002/03 Budget

General 263,407 172,000

Cancer Audit 525,855 1,410,000

Legislation 110,948 151,340

Ethics 2,284

Legal Assessment 48,517

Statistical Reports 8,369 44,460

Policy &Stds Implementation 72,808 219,020

Policy & Stds Review 508,000

Complaints System & Provider Audits

23,198 450,000

Workforce Development 150,986 345,000

Information to Women 4,622 65,000

NZHIS 800,000 191,000

CSI 2,020,631 3,555,820

8 Some expenditure not accounted for in CSI budget, but coded to NSU NDOC


39

Appendix 1: Inquiry Recommendations and Responsibilities

Ref. Recommendation Responsibility

1. Evaluation of NCSP The remaining two phases of the national evaluation designed by the Otago University team must proceed. Until those phases are completed the Programme�s safety for women cannot be known. It is imperative that this exercise is completed within the next six months. Particular attention should be given to the discrepancy between the average reporting rate of high-grade abnormalities of Douglass Hanly Moir Pathology (2.5%-3.7%) for the re-read of the Gisborne women�s smear tests and the current New Zealand national average for reporting high-grade abnormalities (0.8%). Unless this exercise is carried out the possibility that the national average is flawed and that there is a systemic problem of under-reporting in New Zealand laboratories cannot be excluded.

Director of Public Health

2. Re-enrolment and re-screening of women. If the national evaluation throws doubt on the accuracy of the current national average then the Committee recommends that all women who are or who have participated in the Programme should be invited to re-enroll on the register as new entrants and they should be offered two smear tests 12 months apart. Women who have never enrolled on the Register or who have had their names removed from the Register should be invited through notices in the print media to also go through the process of having two smear tests twelve months apart.

National Screening Unit

3. Evaluation of NCSP A comprehensive evaluation of all aspects of the National Cervical Screening Programme which reflects the 1997 Draft Evaluation Plan developed by Doctors Cox and Richardson should be commenced within 18 months. This exercise should build upon the three phase evaluation referred to in recommendation 11.1.


4. Operational Policy and Quality Standards & Evaluation & Monitoring Plan. The Policy And Quality Standards For The National Cervical Screening Programme and the Evaluation and Monitoring Plan For The National Cervical Screening Programme prepared by Dr Julia Peters and her team must be implemented fully within the next 12 months.


5. Full legal assessment of Operational Policy and Quality Standards. There needs to be a full legal assessment of the Policy & Quality Standards for the NCSP and the Evaluation and Monitoring Plan to ensure that the requisite legal authority to carry out these plans is in place.



40


6. Legal assessment of NCSP Authority. The NCSP should be thoroughly evaluated by lawyers to determine whether or not those persons charged with tasks under the NCSP have the necessary legal authority to discharge them.


7. Statistical Reporting. The NCSP should issue annual statistical reports. These reports should provide statistical analysis to indicate the quality of laboratory performance. They should also provide statistical analysis of all other aspects of the programme. They must be critically evaluated to identify areas of deficiency or weakness in the NCSP, these must be remedied in a timely manner.


8. Regular Statistical Information. Meaningful statistical information should be generated from both the National Cervical Screening Register and the Cancer Register on a regular basis. Attention must be paid not only to laboratory reporting rates but also to trends and the incidence of the disease, assessed by regions that are meaningful to allow some correlation between reporting profiles laboratories and the incidence of cancer. Because cervical smear tests may be read outside the region in which the smear test is taken, a recording system needs to be devised which identifies the region where smears are taken.

National Screening Unit NZHIS

9. Minimum Standards for Cytology Laboratories. The compulsory setting of a minimum number of smears that should be ready by laboratories each year must be put in place. The proposal to impose three minimum volume standards on laboratories must be implemented. These are: each fixed site will process a min of 15,000 gynaecology cytology cases, each pathologists will report at least 500 abnormal gynaecological cytology cases, cytotechnical staff must primary screen a min of 3,000 gynaecological cytology cases per annum. This should be implemented within 12 months.


14. Amend S74 of the Health Act 1956. The Health Act 1956 should be amended to permit the National Cervical Screening Programme to be effectively audited, monitored and evaluated by any appropriately qualified persons irrespective of their legal relationship with the Ministry of Health. This requires an amendment to s.74A of the Health Act to permit such persons to have ready access to all information on the National Cervical Screening Register.

Public Health Legislative Review Team

15. Kaitiaki Regulations. There needs to be reconsideration of the Kaitiaki Regulations, and the manner in which those regulations currently effect the Ministry of Health gaining access to aggregate data of Maori Women enrolled on the NCSP-Register. The Ministry of Health and any appropriately qualified persons engaged by it require ready access to the information currently protected by the Kaitiaki Regulations in order to carry out any audit, monitoring or evaluation of the Programme.

Maori Health Directorate


41


16. Legal right to access information from the Cancer Register. The present legal rights of access to information held on the Cancer Registry need to be clarified. The Ministry and any appropriately qualified persons it engages to carry out audits, monitoring, or evaluation of cervical cancer incidence and mortality require ready access to all information stored on the Cancer Registry about persons registered as having cervical cancer.

Public Health Legislative Review Team NZHIS

17. Amend Health Act 1956 to enable access to medical files. The Health Act 1956 requires amendment to enable Ministry of Health and any appropriately qualified persons it engages to carry out audits, monitoring or evaluation of cervical cancer incidence and mortality to have ready access to all medical files recording the treatment of the cervical cancer by all health providers who had a role in such treatment.


18. Change guidelines under-which ethics committees operate. There needs to be change to guidelines under which ethics committees operate to make it clear that any (external and internal) audit, monitoring and evaluation of past and current medical treatment does not require the approval of ethics committees.

Sector Policy

19. Review of operations of ethics committees. There should also be a review of the operation of ethics committees and the impact their decisions are having on independently funded evaluation exercises and on medical research generally in New Zealand.

Sector Policy

20. Provide guidelines to ethics committees regarding Privacy Act & Code. Ethics Committees require guidance regarding the application of the Privacy Act and the Privacy Health Information Code. Ethics Committees need to be informed that the interpretations of legislation relating to personal privacy is for the agency holding a patient�s data to decide. They would, therefore, benefit from having at least one legally qualified person on each regional committee.

Sector Policy

21. Guidelines to ethics committees for observational studies. Ethics committees require guidance regarding the weighing up of harms and benefits in assessing the ethics of observational studies.

Sector Policy

22. National ethics committee � multi-centre studies. A national ethics committee should be established for the assessment of multi-centre or national studies.

Sector Policy


42


23. Appeal process for ethics committee decisions. The procedures under which ethics committees operate need to be re-examined. Consideration should be given to processes to allow their decisions to be appealed to an independent body.

Sector Policy

24. NCSP Complaints System. The National Cervical Screening Programme requires its own system to deal with complaints regarding the Programme�s delivery. It also needs to have in place a user-friendly system which can respond to complaints of Programme failures, such as under-reporting. The difficulty that witness A experienced in having her medical misadventure recognised as a failure of the Programme and a failure of Gisborne Laboratories must be avoided in the future.


25. Electronic Link Cancer Register & NCSP Register. The National Cervical Screening Register needs to be electronically linked with the Cancer Register.


26. Performance Standards for NCSP Register and Cancer Register. Performance standards should be put in place for the National Cervical Screening Register and the Cancer Registry. The currency of the data on both Registers needs to be improved. The Cancer Registry should be funded in a way that enables it to provide timely and accurate data that is meaningful.


27. Standards for the NCSP should be reviewed every two years. Standards for the NCSP should be reviewed every two years and more frequently if monitoring indicates that some of the standards are inappropriate.


28. The Government must ensure sufficient cytotechnologists and cytopathologists and training sites. The Government in consultation with other bodies or agencies needs to ensure that there are sufficient trained cytotechnologists and cytopathologists and that there are appropriate training sites for them. There should also be a review of the training requirements and maintenance of competence of smear test readers and cytopathologists.


29. Amend Medical Laboratory Technologists Regulations 1989. The Medical Laboratory Regulations 1989 should be amended to permit only registered medical practitioners with specialist qualifications in pathology and appropriate training in cytopathology or appropriately trained cytoscreeners to read cervical smear tests.

Sector Policy


43


30. Impose Legal obligations on storage of slides. Legal obligations in addition to those mandated by IANZ must be imposed on all laboratories reading cervical cytology requiring them to retain records of patients� cytology and histology results (including slides, reports and any other material relating to the patient) in safe storage for a period of no less than five years from the date on which the results were reported. Secondly all laboratory owners must be made legally responsible for ensuring that a patient�s records are readily accessible and properly archived during the five year storage period irrespective of changes in the laboratory�s ownership through a sale of shares or a sale of the laboratory�s business. The vendor of the shares or the laboratory�s business should carry a primary legal responsibility to store the records, though the option to transfer this legal responsibility as a condition of the sale to the purchaser should be permitted. Similar provisions should apply to laboratory amalgamations. In this case the newly merged entity should be responsible for storing the records.


31. Ensure electronic linkage between NCSP Register and Cytology Labs. The cervical smear test and histology histories of women enrolled on the National Cervical Screening register should be made electronically available online to all laboratories reading cervical cytology.


32. Develop Standards for accuracy of laboratory coding. Standards must be developed for ensuring the accuracy of laboratory coding and this aspect of the National cervical Screening Register must be subject to an appropriate quality assurance process.


33. The NCSP should develop a population-based register. The NCSP should work towards developing a population based register and move away from being the utility based register that it now is.

NZHIS

34. Legal mechanisms should be in place to allow the ACC, Medical Council and the Health & Disability Commissioner to share relevant information with the Ministry�s NCSP. There should be a legal obligation on the ACC, the Medical Council and the Health and Disability Commissioner to advise the NCSP�s manager of complaints about the professional performance of providers to the Programme when complaints are made to those various organisations about the treatment of a patient in relation to the Programme.

Sector Policy


44


35. Medical Tribunal to supply information to NCSP. Consideration should be given to the addition of an express requirement in the provisions governing medical disciplinary proceedings which would oblige the Tribunal seized of the facts of any given case specifically to consider whether there are any grounds for concern that there may be a public health risk involved. If that concern is present the Tribunal should be required to inform the Minster of Health.

Sector Policy

36. ACC & Medical Council should exchange relevant information regarding claims for medical misadventure. There should be an exchange of information between the Accident Compensation Corporation and Medical Council regarding claims for medical misadventure and disciplinary actions against medical practitioners.

Sector Policy

38 Information to Women. The Programme must provide women with information to enable them to make informed decisions about screening and provide them with information regarding potential risks and benefits. Until the Programme has been monitored and evaluated in accordance with the current three phase national evaluation the Programme has an obligation to inform women that the quality of the performance of some of its parts has not been tested. Women should also be informed that screening will not necessarily detect cervical cancer.


39 Letters to Medical Practitioners. Medical practitioners need to be reminded that cervical smear tests are not a means of diagnosing cervical cancer. They need to be alert to signs of cervical cancer, and they should not place too much reliance on a patient�s smear test results to discount the possibility of cervical cancer being present.


40 Appropriately trained personnel should do cervical screening. Primary screening of cervical smears should only be performed by individuals who are appropriately trained for that task. Consideration should be given to requiring pathologists to train as cytoscreeners if they want to function as primary screeners.


41 All pathologists undertaking cytology should be appropriately trained. If cytology is a significant component of a pathologist�s practice then he or she must participate in continuing medical education in that subject.


42 Cytopathologists must participate in continuing education in cytopathology. If cytology is a major component of a pathologist�s practice, it is desirable that he or she should have added qualifications in cytopathology; either a fellowship slanted towards cytopathology or a diploma in cytopathology. Consideration should be given to making this a mandatory requirement.



45


43 Pathologists ought to be more open-minded. Pathologists should be more open minded and critical of laboratory performance. They should be alert to the possibility that their practice or the practice of their colleagues may be sub-optimal.

44 The Medical Council should ensure that systems are in place to support the early reporting of errant medical practitioners by their colleagues. The Medical Council should ensure that systems are in place whereby medical practitioners are not deterred from reporting to it their concerns about the practice of an individual medical practitioner. Complainants should be assured that their reports will not result in them being penalised in any way.

Sector Policy

45 NCSP should have a system for identifying deficiencies. The screening programme should have in place a system over and above the audit and monitoring reports, to identify deficiencies in its process. A form of survey of users so that they can be proactive rather than reactive in the delivery of the programme would be useful.


46 There should be a process for monitoring the implementation of the Committees Recommendations. A process to ensure that the recommendations made by the Committee are implemented should be put in place.

CSI Steering Group


46

Appendix 2: Summary of Reporting The reports below are available on the Gisborne Ministerial Inquiry website CSI website www.csi.org.nz.

TITLE DATE OF

REPORT

Second Quarterly (10 June to 10 September) Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

10/09/02

First Quarterly (10 April to 10 June) Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

10/06/02

Eleventh Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

18/03/02

Ninth/ Tenth Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

19/02/02

Review of Progress (six month) to Implement the Recommendations of the Gisborne Cervical Screening Inquiry Report. Response to the reports of Dr Euphemia McGoogan and Office of the Auditor General.

07/02/02

Seventh/ Eighth Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

12/12/01

Six-Month Summary Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

26/10/01

Sixth Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

18/10/01


47

TITLE DATE OF REPORT

Fifth Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

24/9/01

Fourth Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

15/08/01

Third Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

16/07/01

Second Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

12/06/01

First Monthly Report From The Ministry Of Health To The Minister On The Implementation Of The Recommendations Of The Gisborne Cervical Screening Inquiry.

08/05/01


48

Appendix 3: Summary of Six-Month Reviews A summary of the key issues of both reviews is provided below.

Table 3.0 Summary9

Key Issue Ministry Comment

a) Progress Reporting:

Criticism regarding the reporting of the status of recommendations as complete or on-track and dissatisfaction with progress on 11 recommendations.

Officials recommend that clarification be sought with Dr McGoogan and the OAG regarding their expectations of progress and agreement for measuring progress.

b) Timetable for Implementation of Recommendations.

Dr McGoogan states that the timetable for implementation is 1 year.

Officials recommend that further clarification be sought from Dr McGoogan regarding the basis for the assumed timetable.

c) Audit of Invasive Cervical Cancer

Concern that the Audit has not yet commenced.

Concern that sufficient expertise has not yet been employed on the Audit.

The NSU advises that it is the data collection (external to Ministry) aspect of the Audit that has not yet commenced. Dr McGoogan states that she is impressed with the work done to date by the NSU�s Cancer Audit Project Team in the first two phases of the Audit design and development.

Since Dr McGoogan�s visit the NSU has made substantial progress in obtaining the expertise to carry out the Audit. This means that the Audit is on target to submit its application to ethics committees in March 2002

d) Legislative Changes

Concern regarding delays and complexities of these changes, as well as concern regarding the use of the discussion document.

Officials have acknowledged the shortcomings of the discussion document given the context of Cabinet decisions and timeframe for its release.

Delay to the introduction of legislative changes is also acknowledged, given the extremely tight timeframe, which was unable to be met given the complexity of policy development and legislative drafting.

e) Ethical Review

Dr McGoogan highlights the difficulties associated with implementing the Inquiry�s Recommendations and concludes that progress is unlikely to be made at present.

Officials agree that ethics committees are not in support of the Inquiry Recommendations.

9 Table included within Briefing on Ministry Response to 6-Month Reviews.


49

Key Issue Ministry Comment

f) Smear Takers

Dr McGoogan highlights difficulties associated with implementing standards for smear-takers and ensuring appropriate training.

The ability to ensure that smear takers meet the standards required of NCSP is a concern to the NSU. The main obstacle is the current unavailability of contractual or other mechanisms, including appropriate funding, to ensure standards are met. Development of the most appropriate mechanisms will need to be the subject of ongoing policy development work, pending available resources.

g) NSU Organisation and Workforce

Both reviews highlighted issues related to the available workforce required to implement the recommendations and for the ongoing operation of the NCSP. Structural issues related to the authority of the NSU and the qualifications of the Group Manager are also highlighted.

The NSU acknowledges recruitment and workforce difficulties. The availability of skilled and experienced workforce is limited and requires some time to build up. The NSU will need to re-prioritise work including the Inquiry Recommendations.

The NSU acknowledges that the Group Manager does not hold medical qualifications but that the operations of the NSU necessitate this approach. Dr McGoogan, however, acknowledges the managerial skills, leadership and expertise of the Group Manager despite the lack of medical qualification.

h) Information to Women

Dr McGoogan expresses concern over the need to ensure women are adequately informed regarding the risks and benefits of cervical screening. This relates to the ability of the NSU to provide more timely information and the ability of health service practitioners to discuss aspects of the programme adequately.

The NSU has supplied Dr McGoogan with the full range of available information for women, which were not acknowledged in her report. The NSU acknowledges that a new booklet has taken time to develop. The NSU agrees that information provided to women by health practitioners has not been adequately assessed and relates to the ability of the NSU to mandate standards for primary care in particular.


50

Appendix 4: April 2001 Plan Ref Recommendation Status Timeframe10 1. Parts 2 and 3 of the National Evaluation of the National

Cervical Screening Programme (NCSP) to be completed with six months.

Work In Progress Completion: Part 2: 30 June 2001 Part 3: August 200211

2 Once Part 3 is completed and if there is any doubt about the acceptable rate of abnormal smears in New Zealand, then all women should be asked to re-enrol in the NCSP and have two annual smears.

If Required on Completion of Part 3

From January 2003

3 Cox's 1997 recommended evaluation of the NCSP should be commenced within eighteen months.

Of the 13 aspects of the evaluation, 5 are Complete, 2 are In Progress.

Remaining 6 aspects to commence prior to August 2002

4 The Policy and Quality Standards for the National Cervical Screening Programme and the Evaluation and Monitoring Plan for the National Cervical Screening Programme should be implemented fully within the next 12 months.

Completed Final Implementation1 July 2001

5 There should be a full legal assessment of the Policy and Quality Standards for the National Cervical Screening Programme and the Evaluation and Monitoring Plan for the National Cervical Screening Programme.

To Commence Complete by Nov 2001

6 The NCSP should be legally assessed for the authority to discharge its responsibilities.

To Commence Complete by Nov 2001

7 The NCSP should issue statistical reports on an annual basis. These reports to focus on quality aspects of the NCSP, including laboratory quality.

Current Practice 1996 to 1998 Report by 30 June 2001 1999/2000 Report by December 2001

8 The Cancer Register and NCSP-Register should generate regular statistical information. This information to include regional laboratory reporting rates as well as trends and incidence of disease.

Current Practice, scope can be reviewed

Ongoing

9 All cytology laboratories should comply with a standard related to minimum volumes per annum

Completed Final Implementation by 1 July 2001

10 There needs to be a balanced approach to all aspects of the NCSP

Current Practice Ongoing

11 Dr Julia Peter's culture needs to be preserved Current Practice Ongoing 12 The NCSP must be managed within the Ministry as a

separate unit, lead by a manager with the authority to contract directly with providers


13 The NCSP manager should be second or third tier. The manager to hold medical specialist qualifications in public health or epidemiology

*12

10 Where the timeframe refers to Legislation, the date upon which that legislation might come into force will depend upon whether particular elements are fast tracked and upon availability of parliamentary time. 11 Scope of Audit may require legislative change and Footnote 1 is relevant to this. 12 Dr Julia Peters, a specialist in public health medicine, is the clinical leader for the NCSP. This leadership role is shared with a recently appointed third tier manager.


51

Ref Recommendation Status Timeframe10 14 Amend s74A of the Health Act 1956 to enable audit and

evaluation of the NCSP Currently already approved by Cabinet (Legislative changes required) Consultation to occur in June/July

Complete by June 2002, but note that this is likely to require fast tracking, see footnote 1.

15 Reconsider the Kaitiaki Regulations to ensure appropriate access to aggregated Maori data for audit, monitoring and evaluation

(Legislative changes required)

Complete by June 2002

16 Clarify the legal right to access information on the Cancer Register



17 Amend the Health Act 1956 to enable access to all medical files pertaining to the treatment of women with cervical cancer, for audit purposes.



18 Change the guidelines under which ethics committees operate.

To Commence (Review by National Ethics Committee: legislated for in the NZPHD Act 2000)

From September 200113

19 Review the operation of the ethics committees, including the impact of their decisions on the evaluation of services and medical research generally

To Commence (Review by National Ethics Committee)

From September 2001

20 Provide guidelines to ethics committees regarding application of the Privacy Act and Privacy Health Information Code. A Lawyer should sit on each ethics committee

Work in Progress Complete by June 2001

21 Provide guidance to ethics committees about the ways to balance harms and benefits of observational studies

Work in Progress Complete by June 2001

22 Establish a national ethics committee for multi-centre studies Work in Progress Complete by Sept 2001

23 Establish an appeal procedure to allow for re-examination of ethics committee decisions

To Commence From September 2001

24 The NCSP should have its own consumer complaints system To Commence Complete by Nov 2001

25 Electronically link the Cancer Register and the NCSP-Register

To Commence (Legislative changes required)

From June 200214

26 There should be Performance Standards for the NCSP-Register and the Cancer Register

Work in Progress Complete by December 2001

27 Standards for the NCSP should be reviewed every two years To Commence First Review by October 2002

28 The Government must ensure sufficient cytotechnologists and cytopathologists and sufficient training sites

Work in Progress (Workforce Development Project)

Project Work Complete by December 2001

29 Amend the Medical Laboratory Technologists Regulations 1989 to permit only registered practitioners with specialist qualifications in pathology and appropriate training in cytopathology or appropriately trained cytoscreeners to read smears

To Commence (legislative changes required)


13 Committee membership proposals to go to Cabinet shortly. 14 Date to be confirmed once scope determined as part of the NSU Information Systems Strategy Review.


52

Ref Recommendation Status Timeframe10 30 Impose legal obligations, related to storage of slides, on

laboratories that take over slides from laboratories that close To Commence (legislative changes required)


31 Ensure electronic linkage between NCSP-Register and cytology laboratories

To Commence (Legislative changes required)

From June 200215

32 Develop standards for accuracy of laboratory coding Work in Progress (Refer 27, Standards Review)


33 The NCSP should develop a population register To Commence Project

*16

34 Legal Mechanisms should be in place to allow the ACC, Medical Council, and the Health and Disability Commissioner to share relevant information with the Ministry's NCSP.


Complete by June 2002 (this is linked to Cull Report Recommendation)

35 The Medical Tribunal should be required to provide relevant information to the Ministry's NCSP if there is a threat to public health.



36 The ACC and Medical Council should exchange relevant information regarding claims for medical misadventure and disciplinary actions against medical practitioners.

Implemented in part. Further work to Commence (legislative changes required)


37 The NCSP should establish a collaborative relationship with the Royal College of Pathologists of Australasia.


38 The NCSP should provide women with explicit information about the risks and benefits of the NCSP, including information that the Programme has not been fully tested.


39 Remind medical practitioners that cervical smear takes are not a diagnostic tool

To Commence Ministry Letter to go out by May 2001

40 Cervical screening should be done by appropriately trained personnel - including pathologists who want to function as primary screeners



41 Cytopathologists must participate in continuing education in cytopathology



42 All pathologists undertaking cytology should be appropriately trained. This ought to be mandatory.



43 Pathologists ought to be more open minded and critical of laboratory performance

To Commence Ministry Letter to go out by May 2001

44 The Medical Council should ensure that systems are in place to support the early reporting of errant medical practitioners by their colleagues

To Implement. Policy work completed (legislative changes required)


45 The NCSP should have a system for identifying deficiencies. Consumer surveys are recommended

Work in Progress Ongoing

15 Refer to Footnote 2. 16 Refer to Footnote 2.


53

Ref Recommendation Status Timeframe10 46

There should be a process for monitoring the implementation of the Committee's recommendations.

Minister is appointing an international expert to assess progress in 6 months and 1 year. Minister will receive monthly reports for the first 6 months. The reporting timeframe will be reviewed thereafter.

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m la

te

2001

, eth

ics

appl

icat

ion

and

appr

oval

, res

pons

e to

hea

lth

prof

essi

onal

con

cern

s

2.

R

e-en

rolm

ent a

nd re

-scr

eeni

ng o

f w

omen

. If

the

natio

nal e

valu

atio

n th

row

s do

ubt o

n th

e ac

cura

cy o

f the

cur

rent

nat

iona

l ave

rage

then

th

e C

omm

ittee

reco

mm

ends

that

all

wom

en

who

are

or w

ho h

ave

parti

cipa

ted

in th

e Pr

ogra

mm

e sh

ould

be

invi

ted

to re

-enr

oll o

n th

e re

gist

er a

s ne

w e

ntra

nts

and

they

sho

uld

be o

ffere

d tw

o sm

ear t

ests

12

mon

ths

apar

t.

Wom

en w

ho h

ave

neve

r enr

olle

d on

the

Reg

iste

r or w

ho h

ave

had

thei

r nam

es

rem

oved

from

the

Reg

iste

r sho

uld

be in

vite

d th

roug

h no

tices

in th

e pr

int m

edia

to a

lso

go

thro

ugh

the

proc

ess

of h

avin

g tw

o sm

ear t

ests

tw

elve

mon

ths

apar

t.

3.

Ev

alua

tion

of N

CSP

A

com

preh

ensi

ve e

valu

atio

n of

all

aspe

cts

of

the

Nat

iona

l Cer

vica

l Scr

eeni

ng P

rogr

amm

e w

hich

refle

cts

the

1997

Dra

ft Ev

alua

tion

Plan

de

velo

ped

by D

octo

rs C

ox a

nd R

icha

rdso

n sh

ould

be

com

men

ced

with

in 1

8 m

onth

s. T

his

exer

cise

sho

uld

build

upo

n th

e th

ree

phas

e ev

alua

tion

refe

rred

to in

reco

mm

enda

tion

1.

To c

omm

ence

by

Aug

2002

D

ec 2

002

Dec

200

2 So

me

aspe

cts

alre

ady

com

plet

ed o

r inc

lude

d w

ithin

ot

her w

ork

incl

udin

g C

ance

r Au

dit a

nd S

tatis

tical

R

epor

ting.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

56

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

4.

O

pera

tiona

l Pol

icy

and

Qua

lity

Stan

dard

s &

Eva

luat

ion

&

Mon

itorin

g Pl

an.

The

Polic

y An

d Q

ualit

y St

anda

rds

For T

he

Nat

iona

l Cer

vica

l Scr

eeni

ng P

rogr

amm

e an

d th

e Ev

alua

tion

and

Mon

itorin

g Pl

an F

or T

he

Nat

iona

l Cer

vica

l Scr

eeni

ng P

rogr

amm

e pr

epar

ed b

y D

r Jul

ia P

eter

s an

d he

r tea

m m

ust

be im

plem

ente

d fu

lly w

ithin

the

next

12

mon

ths

DH

Bs &

Lab

orat

orie

s

Smea

r Tak

ers

Jul 2

001

Jul 2

001

Jul 2

003

Jul 2

003

Del

ay in

impl

emen

ting

smea

rtaki

ng s

tand

ards

. NSU

do

es n

ot c

ontra

ct d

irect

ly

with

sm

earta

kers

.

5.

Fu

ll le

gal a

sses

smen

t of

Ope

ratio

nal P

olic

y an

d Q

ualit

y St

anda

rds.

Th

ere

need

s to

be

a fu

ll le

gal a

sses

smen

t of

the

Polic

y &

Qua

lity

Stan

dard

s fo

r the

NC

SP

and

the

Eval

uatio

n an

d M

onito

ring

Plan

to

ensu

re th

at th

e re

quis

ite le

gal a

utho

rity

to c

arry

ou

t the

se p

lans

is in

pla

ce.

Nov

200

1 N

ov 2

001

Com

plet

e M

ar 0

2

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

57

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

6.

Le

gal a

sses

smen

t of N

CSP

A

utho

rity.

Th

e N

CSP

sho

uld

be th

orou

ghly

eva

luat

ed b

y la

wye

rs to

det

erm

ine

whe

ther

or n

ot th

ose

pers

ons

char

ged

with

task

s un

der t

he N

CSP

ha

ve th

e ne

cess

ary

lega

l aut

horit

y to

dis

char

ge

them

.

Nov

200

1 N

ov 2

001

Com

plet

e M

ar 0

2

7.

St

atis

tical

Rep

ortin

g Th

e N

CSP

sho

uld

issu

e an

nual

sta

tistic

al

repo

rts.

Thes

e re

ports

sho

uld

prov

ide

stat

istic

al a

naly

sis

to in

dica

te th

e qu

ality

of

labo

rato

ry p

erfo

rman

ce.

They

sho

uld

also

pr

ovid

e st

atis

tical

ana

lysi

s of

all

othe

r asp

ects

of

the

prog

ram

me.

The

y m

ust b

e cr

itica

lly

eval

uate

d to

iden

tify

area

s of

def

icie

ncy

or

wea

knes

s in

the

NC

SP, t

hese

mus

t be

rem

edie

d in

a ti

mel

y m

anne

r.

1996

-98

1999

-00

Jun

2001

Dec

200

1

Dec

200

1

Dec

200

2

Com

plet

e Ap

r 02

Dec

200

2

Con

sulta

tion

on fi

nalis

atio

n of

NC

SP S

tatis

tics

Rep

ort

1996

/98

has

push

ed o

ut

prep

arat

ion

of n

ext r

epor

t.

Rev

ised

tim

etab

le d

ue to

pl

anne

d la

te p

ublic

atio

n of

N

CSP

Sta

tistic

s R

epor

t 19

90/0

0.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

58

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

8.

R

egul

ar S

tatis

tical

Info

rmat

ion.

M

eani

ngfu

l st

atis

tical

in

form

atio

n sh

ould

be

ge

nera

ted

from

bo

th

the

Nat

iona

l C

ervi

cal

Scre

enin

g R

egis

ter

and

the

Can

cer

Reg

iste

r on

a re

gula

r bas

is.

Atte

ntio

n m

ust b

e pa

id n

ot

only

to

labo

rato

ry r

epor

ting

rate

s bu

t al

so t

o tre

nds

and

the

inci

denc

e of

th

e di

seas

e,

asse

ssed

by

regi

ons

that

are

mea

ning

ful

to

allo

w

som

e co

rrela

tion

betw

een

repo

rting

pr

ofile

s la

bora

torie

s an

d th

e in

cide

nce

of

canc

er.

Beca

use

cerv

ical

sm

ear

test

s m

ay b

e re

ad o

utsi

de th

e re

gion

in w

hich

the

smea

r tes

t is

ta

ken,

a

reco

rdin

g sy

stem

ne

eds

to

be

devi

sed

whi

ch

iden

tifie

s th

e re

gion

w

here

sm

ears

are

take

n.

Dec

200

1 D

ec 2

002

As a

bove

C

onsu

ltatio

n on

fina

lisat

ion

of N

CSP

Sta

tistic

s R

epor

t 19

96/9

8 ha

s pu

shed

out

pr

epar

atio

n of

nex

t rep

ort.

R

evis

ed ti

met

able

due

to

plan

ned

late

pub

licat

ion

of

NC

SP S

tatis

tics

Rep

ort

1990

/00

9.

M

inim

um S

tand

ards

for C

ytol

ogy

Labo

rato

ries.

Th

e co

mpu

lsor

y se

tting

of a

min

imum

num

ber

of s

mea

rs th

at s

houl

d be

read

y by

labo

rato

ries

each

yea

r mus

t be

put i

n pl

ace.

The

pro

posa

l to

impo

se th

ree

min

imum

vol

ume

stan

dard

s on

la

bora

torie

s m

ust b

e im

plem

ente

d. T

hese

are

: ea

ch fi

xed

site

will

proc

ess

a m

in o

f 15,

000

gyna

ecol

ogy

cyto

logy

cas

es, e

ach

path

olog

ists

w

ill re

port

at le

ast 5

00 a

bnor

mal

gy

naec

olog

ical

cyt

olog

y ca

ses,

cyt

otec

hnic

al

staf

f mus

t prim

ary

scre

en a

min

of 3

,000

gy

naec

olog

ical

cyt

olog

y ca

ses

per a

nnum

. Th

is s

houl

d be

impl

emen

ted

with

in 1

2 m

onth

s.

Jul 2

001

Jul 2

001

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

59

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

10.

Ther

e ne

eds

to b

e a

bala

nced

app

roac

h,

whi

ch re

cogn

ises

the

impo

rtanc

e of

all

aspe

cts

of th

e N

CSP

.

11.

The

cultu

re th

at w

as d

evel

opin

g in

the

HFA

rega

rdin

g th

e m

anag

emen

t of t

he

NC

SP u

nder

the

man

agem

ent o

f Dr J

ulia

Pe

ters

nee

ds to

be

pres

erve

d.

12.

The

NC

SP m

ust b

e m

anag

ed w

ithin

the

MoH

as

a se

para

te u

nit b

y a

man

ager

who

ha

s th

e po

wer

to c

ontra

ct d

irect

ly w

ith th

e pr

ovid

ers

of th

e pr

ogra

mm

e.

13.

The

NC

SP s

houl

d be

und

er th

e co

ntro

l of

a se

cond

or t

hird

tier

man

ager

with

in th

e M

inis

try.

The

Man

ager

of t

he u

nit s

houl

d as

a m

inim

um h

old

spec

ialis

t med

ical

qu

alifi

catio

ns

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

60

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

14.

Am

end

S74

of th

e H

ealth

Act

195

6.

The

Hea

lth A

ct 1

956

shou

ld b

e am

ende

d to

pe

rmit

the

Nat

iona

l C

ervi

cal

Scre

enin

g Pr

ogra

mm

e to

be

ef

fect

ivel

y au

dite

d,

mon

itore

d an

d ev

alua

ted

by a

ny a

ppro

pria

tely

qu

alifi

ed

pers

ons

irres

pect

ive

of

thei

r le

gal

rela

tions

hip

with

the

Min

istry

of

Hea

lth.

Thi

s re

quire

s an

am

endm

ent t

o s.

74A

of th

e H

ealth

Ac

t to

per

mit

such

per

sons

to

have

rea

dy

acce

ss

to

all

info

rmat

ion

on

the

Nat

iona

l C

ervi

cal S

cree

ning

Reg

iste

r.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

15.

Kai

tiaki

Reg

ulat

ions

. Th

ere

need

s to

be

reco

nsid

erat

ion

of th

e Ka

itiak

i Reg

ulat

ions

, and

the

man

ner i

n w

hich

th

ose

regu

latio

ns c

urre

ntly

effe

ct th

e M

inis

try

of H

ealth

gai

ning

acc

ess

to a

ggre

gate

dat

a of

M

aori

Wom

en e

nrol

led

on th

e N

CSP

-Reg

iste

r.

The

Min

istry

of H

ealth

and

any

app

ropr

iate

ly

qual

ified

per

sons

eng

aged

by

it re

quire

read

y ac

cess

to th

e in

form

atio

n cu

rrent

ly p

rote

cted

by

the

Kaiti

aki R

egul

atio

ns in

ord

er to

car

ry o

ut

any

audi

t, m

onito

ring

or e

valu

atio

n of

the

Prog

ram

me.

Jun

2002

Ju

n 20

02

Com

plet

e Ju

n 02

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

61

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

16.

Lega

l rig

ht to

acc

ess

info

rmat

ion

from

the

Can

cer R

egis

ter.

The

pres

ent l

egal

righ

ts o

f acc

ess

to

info

rmat

ion

held

on

the

Can

cer R

egis

try n

eed

to b

e cl

arifi

ed.

The

Min

istry

and

any

ap

prop

riate

ly q

ualif

ied

pers

ons

it en

gage

s to

ca

rry o

ut a

udits

, mon

itorin

g, o

r eva

luat

ion

of

cerv

ical

can

cer i

ncid

ence

and

mor

talit

y re

quire

re

ady

acce

ss to

all

info

rmat

ion

stor

ed o

n th

e C

ance

r Reg

istry

abo

ut p

erso

ns re

gist

ered

as

havi

ng c

ervi

cal c

ance

r.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

17.

Am

end

Hea

lth A

ct 1

956

to e

nabl

e ac

cess

to m

edic

al fi

les.

Th

e H

ealth

Act

195

6 re

quire

s am

endm

ent t

o en

able

Min

istry

of H

ealth

and

any

app

ropr

iate

ly

qual

ified

per

sons

it e

ngag

es to

car

ry o

ut

audi

ts, m

onito

ring

or e

valu

atio

n of

cer

vica

l ca

ncer

inci

denc

e an

d m

orta

lity

to h

ave

read

y ac

cess

to a

ll m

edic

al fi

les

reco

rdin

g th

e tre

atm

ent o

f the

cer

vica

l can

cer b

y al

l hea

lth

prov

ider

s w

ho h

ad a

role

in s

uch

treat

men

t.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

62

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

18.

Cha

nge

guid

elin

es u

nder

-whi

ch

ethi

cs c

omm

ittee

s op

erat

e.

Ther

e ne

eds

to b

e ch

ange

to g

uide

lines

und

er

whi

ch e

thic

s co

mm

ittee

s op

erat

e to

mak

e it

clea

r tha

t any

(ext

erna

l and

inte

rnal

) aud

it,

mon

itorin

g an

d ev

alua

tion

of p

ast a

nd c

urre

nt

med

ical

trea

tmen

t doe

s no

t req

uire

the

appr

oval

of e

thic

s co

mm

ittee

s.

To c

omm

ence

Sep

t 20

01

Com

men

ced

Com

plet

ed O

ct 0

1

19.

Rev

iew

of o

pera

tions

of e

thic

s co

mm

ittee

s.

Ther

e sh

ould

als

o be

a re

view

of t

he o

pera

tion

of e

thic

s co

mm

ittee

s an

d th

e im

pact

thei

r de

cisi

ons

are

havi

ng o

n in

depe

nden

tly fu

nded

ev

alua

tion

exer

cise

s an

d on

med

ical

rese

arch

ge

nera

lly in

New

Zea

land

.

To c

omm

ence

Sep

t 20

01

Com

men

ced

20

02/0

3 tim

etab

le

depe

nden

t upo

n co

nsid

erat

ion

by N

atio

nal

Ethi

cs C

omm

ittee

20.

Prov

ide

guid

elin

es to

eth

ics

com

mitt

ees

rega

rdin

g Pr

ivac

y A

ct

& C

ode.

Et

hics

Com

mitt

ees

requ

ire g

uida

nce

rega

rdin

g th

e ap

plic

atio

n of

the

Priv

acy

Act a

nd th

e Pr

ivac

y H

ealth

Info

rmat

ion

Cod

e. E

thic

s C

omm

ittee

s ne

ed to

be

info

rmed

that

the

inte

rpre

tatio

ns o

f leg

isla

tion

rela

ting

to

pers

onal

priv

acy

is fo

r the

age

ncy

hold

ing

a pa

tient

�s d

ata

to d

ecid

e. T

hey

wou

ld,

ther

efor

e, b

enef

it fro

m h

avin

g at

leas

t one

le

gally

qua

lifie

d pe

rson

on

each

regi

onal

co

mm

ittee

.

Jun

2001

Se

pt 2

001

Com

plet

e O

ct 0

1

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

63

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

21.

Gui

delin

es to

eth

ics

com

mitt

ees

for

obse

rvat

iona

l stu

dies

. Et

hics

com

mitt

ees

requ

ire g

uida

nce

rega

rdin

g th

e w

eigh

ing

up o

f har

ms

and

bene

fits

in

asse

ssin

g th

e et

hics

of o

bser

vatio

nal s

tudi

es.

Jun

2001

C

omm

ence

d

2002

/03

timet

able

de

pend

ent u

pon

cons

ider

atio

n by

Nat

iona

l Et

hics

Com

mitt

ee

22.

Nat

iona

l Eth

ics

Com

mitt

ee �

mul

ti-ce

ntre

stu

dies

. A

natio

nal e

thic

s co

mm

ittee

sho

uld

be

esta

blis

hed

for t

he a

sses

smen

t of m

ulti-

cent

re

or n

atio

nal s

tudi

es.

Sept

200

1 C

omm

ence

d

2002

/03

timet

able

de

pend

ent u

pon

cons

ider

atio

n by

Nat

iona

l Et

hics

Com

mitt

ee

23.

App

eal p

roce

ss fo

r eth

ics

com

mitt

ee d

ecis

ions

. Th

e pr

oced

ures

und

er w

hich

eth

ics

com

mitt

ees

oper

ate

need

to b

e re

-exa

min

ed.

Con

side

ratio

n sh

ould

be

give

n to

pro

cess

es to

al

low

thei

r dec

isio

ns to

be

appe

aled

to a

n in

depe

nden

t bod

y.

To c

omm

ence

Sep

t 20

01

Com

men

ced

20

02/0

3 tim

etab

le

depe

nden

t upo

n co

nsid

erat

ion

by N

atio

nal

Ethi

cs C

omm

ittee

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

64

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

24.

NC

SP C

ompl

aint

s Sy

stem

. Th

e N

atio

nal C

ervi

cal S

cree

ning

Pro

gram

me

requ

ires

its o

wn

syst

em to

dea

l with

com

plai

nts

rega

rdin

g th

e Pr

ogra

mm

e�s

deliv

ery.

It a

lso

need

s to

hav

e in

pla

ce a

use

r-frie

ndly

sys

tem

w

hich

can

resp

ond

to c

ompl

aint

s of

Pr

ogra

mm

e fa

ilure

s, s

uch

as u

nder

-repo

rting

. Th

e di

fficu

lty th

at w

itnes

s A

expe

rienc

ed in

ha

ving

her

med

ical

mis

adve

ntur

e re

cogn

ised

as

a fa

ilure

of t

he P

rogr

amm

e an

d a

failu

re o

f G

isbo

rne

Labo

rato

ries

mus

t be

avoi

ded

in th

e fu

ture

.

Nov

200

1 Ju

n 20

02

Com

men

ced

25.

Elec

tron

ic L

ink

Can

cer R

egis

ter &

N

CSP

Reg

iste

r. Th

e N

atio

nal C

ervi

cal S

cree

ning

Reg

iste

r ne

eds

to b

e el

ectro

nica

lly li

nked

with

the

Can

cer R

egis

ter.

From

Jun

200

2

Com

plet

e N

ov 0

1

26.

Perf

orm

ance

Sta

ndar

ds fo

r NC

SP

Reg

iste

r and

Can

cer R

egis

ter.

Perfo

rman

ce s

tand

ards

sho

uld

be p

ut in

pla

ce

for t

he N

atio

nal C

ervi

cal S

cree

ning

Reg

iste

r an

d th

e C

ance

r Reg

istry

. Th

e cu

rrenc

y of

the

data

on

both

Reg

iste

rs n

eeds

to b

e im

prov

ed.

The

Can

cer R

egis

try s

houl

d be

fund

ed in

a

way

that

ena

bles

it to

pro

vide

tim

ely

and

accu

rate

dat

a th

at is

mea

ning

ful.

Dec

200

1 Ju

n 20

02

Com

men

ced

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

65

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

27.

Stan

dard

s fo

r the

NC

SP s

houl

d be

re

view

ed e

very

two

year

s.

Stan

dard

s fo

r the

NC

SP s

houl

d be

revi

ewed

ev

ery

two

year

s an

d m

ore

frequ

ently

if

mon

itorin

g in

dica

tes

that

som

e of

the

stan

dard

s ar

e in

appr

opria

te.

Oct

ober

200

2 D

ec 2

002

Com

men

ced

28.

The

Gov

ernm

ent m

ust e

nsur

e su

ffici

ent c

ytot

echn

olog

ists

and

cy

topa

thol

ogis

ts a

nd tr

aini

ng s

ites.

Th

e G

over

nmen

t in

cons

ulta

tion

with

oth

er

bodi

es o

r age

ncie

s ne

eds

to e

nsur

e th

at th

ere

are

suffi

cien

t tra

ined

cyt

otec

hnol

ogis

ts a

nd

cyto

path

olog

ists

and

that

ther

e ar

e ap

prop

riate

tra

inin

g si

tes

for t

hem

. Th

ere

shou

ld a

lso

be a

re

view

of t

he tr

aini

ng re

quire

men

ts a

nd

mai

nten

ance

of c

ompe

tenc

e of

sm

ear t

est

read

ers

and

cyto

path

olog

ists

.

Proj

ect w

ork

com

plet

e by

Dec

200

1 D

ec 2

001

Ong

oing

29.

Am

end

Med

ical

Lab

orat

ory

Tech

nolo

gist

s R

egul

atio

ns 1

989.

Th

e M

edic

al L

abor

ator

y R

egul

atio

ns 1

989

shou

ld b

e am

ende

d to

per

mit

only

regi

ster

ed

med

ical

pra

ctiti

oner

s w

ith s

peci

alis

t qu

alifi

catio

ns in

pat

holo

gy a

nd a

ppro

pria

te

train

ing

in c

ytop

atho

logy

or a

ppro

pria

tely

tra

ined

cyt

oscr

eene

rs to

read

cer

vica

l sm

ear

test

s.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

66

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

30.

Impo

se L

egal

obl

igat

ions

on

stor

age

of s

lides

. Le

gal o

blig

atio

ns in

add

ition

to th

ose

man

date

d by

IAN

Z m

ust

be i

mpo

sed

on a

ll la

bora

torie

s re

adin

g ce

rvic

al

cyto

logy

re

quiri

ng

them

to

re

tain

re

cord

s of

pa

tient

s�

cyto

logy

an

d hi

stol

ogy

resu

lts (

incl

udin

g sl

ides

, re

ports

and

an

y ot

her

mat

eria

l re

latin

g to

the

pat

ient

) in

sa

fe s

tora

ge f

or a

per

iod

of n

o le

ss t

han

five

year

s fro

m th

e da

te o

n w

hich

the

resu

lts w

ere

repo

rted.

Sec

ondl

y al

l lab

orat

ory

owne

rs m

ust

be m

ade

lega

lly re

spon

sibl

e fo

r ens

urin

g th

at a

pa

tient

�s r

ecor

ds a

re r

eadi

ly a

cces

sibl

e an

d pr

oper

ly a

rchi

ved

durin

g th

e fiv

e ye

ar s

tora

ge

perio

d irr

espe

ctiv

e of

ch

ange

s in

th

e la

bora

tory

�s

owne

rshi

p th

roug

h a

sale

of

sh

ares

or

a sa

le o

f th

e la

bora

tory

�s b

usin

ess.

Th

e ve

ndor

of

the

shar

es o

r th

e la

bora

tory

�s

busi

ness

sh

ould

ca

rry

a pr

imar

y le

gal

resp

onsi

bilit

y to

sto

re t

he r

ecor

ds,

thou

gh t

he

optio

n to

tra

nsfe

r th

is le

gal r

espo

nsib

ility

as a

co

nditi

on o

f th

e sa

le t

o th

e pu

rcha

ser

shou

ld

be p

erm

itted

. S

imila

r pr

ovis

ions

sho

uld

appl

y to

labo

rato

ry a

mal

gam

atio

ns.

In th

is c

ase

the

new

ly m

erge

d en

tity

shou

ld b

e re

spon

sibl

e fo

r st

orin

g th

e re

cord

s.

June

200

2 Ju

ne 2

002

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

67

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

31.

Ensu

re e

lect

roni

c lin

kage

bet

wee

n N

CSP

Reg

iste

r and

Cyt

olog

y La

bs.

The

cerv

ical

sm

ear t

est a

nd h

isto

logy

his

torie

s of

wom

en e

nrol

led

on th

e N

atio

nal C

ervi

cal

Scre

enin

g re

gist

er s

houl

d be

mad

e el

ectro

nica

lly a

vaila

ble

onlin

e to

all

labo

rato

ries

read

ing

cerv

ical

cyt

olog

y.

Jun

2002

Ju

n 20

02

Com

plet

e/on

goin

g

32.

Dev

elop

Sta

ndar

ds fo

r acc

urac

y of

la

bora

tory

cod

ing.

St

anda

rds

mus

t be

deve

lope

d fo

r ens

urin

g th

e ac

cura

cy o

f lab

orat

ory

codi

ng a

nd th

is a

spec

t of

the

Nat

iona

l cer

vica

l Scr

eeni

ng R

egis

ter

mus

t be

subj

ect t

o an

app

ropr

iate

qua

lity

assu

ranc

e pr

oces

s.

Jun

2002

Ju

n 20

02

Com

men

ced

33.

The

NC

SP s

houl

d de

velo

p a

popu

latio

n-ba

sed

regi

ster

. Th

e N

CSP

sho

uld

wor

k to

war

ds d

evel

opin

g a

popu

latio

n ba

sed

regi

ster

and

mov

e aw

ay fr

om

bein

g th

e ut

ility

base

d re

gist

er th

at it

now

is.

Ju

n 20

03

Jun

2003

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

68

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

34.

Lega

l mec

hani

sms

shou

ld b

e in

pl

ace

to a

llow

the

AC

C, M

edic

al

Cou

ncil

and

the

Hea

lth &

Dis

abili

ty

Com

mis

sion

er to

sha

re re

leva

nt

info

rmat

ion

with

the

Min

istr

y�s

NC

SP.

Ther

e sh

ould

be

a le

gal o

blig

atio

n on

the

ACC

, th

e M

edic

al C

ounc

il an

d th

e H

ealth

and

D

isab

ility

Com

mis

sion

er to

adv

ise

the

NC

SP�s

m

anag

er o

f com

plai

nts

abou

t the

pro

fess

iona

l pe

rform

ance

of p

rovi

ders

to th

e Pr

ogra

mm

e w

hen

com

plai

nts

are

mad

e to

thos

e va

rious

or

gani

satio

ns a

bout

the

treat

men

t of a

pat

ient

in

rela

tion

to th

e Pr

ogra

mm

e.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

35.

Med

ical

Trib

unal

to s

uppl

y in

form

atio

n to

NC

SP.

Con

side

ratio

n sh

ould

be

give

n to

the

addi

tion

of a

n ex

pres

s re

quire

men

t in

the

prov

isio

ns

gove

rnin

g m

edic

al d

isci

plin

ary

proc

eedi

ngs

whi

ch w

ould

obl

ige

the

Trib

unal

sei

zed

of th

e fa

cts

of a

ny g

iven

cas

e sp

ecifi

cally

to c

onsi

der

whe

ther

ther

e ar

e an

y gr

ound

s fo

r con

cern

that

th

ere

may

be

a pu

blic

hea

lth ri

sk in

volv

ed.

If th

at c

once

rn is

pre

sent

the

Trib

unal

sho

uld

be

requ

ired

to in

form

the

Min

ster

of H

ealth

.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

69

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

36.

AC

C &

Med

ical

Cou

ncil

shou

ld

exch

ange

rele

vant

info

rmat

ion

rega

rdin

g cl

aim

s fo

r med

ical

m

isad

vent

ure.

Th

ere

shou

ld b

e an

exc

hang

e of

info

rmat

ion

betw

een

the

Acci

dent

Com

pens

atio

n C

orpo

ratio

n an

d M

edic

al C

ounc

il re

gard

ing

clai

ms

for m

edic

al m

isad

vent

ure

and

disc

iplin

ary

actio

ns a

gain

st m

edic

al

prac

titio

ners

.

Jun

2002

Ju

n 20

02

Com

plet

ed A

pr 0

2

37.

It is

reco

mm

ende

d th

at th

e pr

ogra

mm

e lia

se

with

the

Roy

al C

olle

ge o

f Pat

holo

gist

s of

Au

stra

lia

38.

Info

rmat

ion

to W

omen

. Th

e Pr

ogra

mm

e m

ust p

rovi

de w

omen

with

in

form

atio

n to

ena

ble

them

to m

ake

info

rmed

de

cisi

ons

abou

t scr

eeni

ng a

nd p

rovi

de th

em

with

info

rmat

ion

rega

rdin

g po

tent

ial r

isks

and

be

nefit

s. U

ntil

the

Prog

ram

me

has

been

m

onito

red

and

eval

uate

d in

acc

orda

nce

with

th

e cu

rrent

thre

e ph

ase

natio

nal e

valu

atio

n th

e Pr

ogra

mm

e ha

s an

obl

igat

ion

to in

form

wom

en

that

the

qual

ity o

f the

per

form

ance

of s

ome

of

its p

arts

has

not

bee

n te

sted

. W

omen

sho

uld

also

be

info

rmed

that

scr

eeni

ng w

ill no

t ne

cess

arily

det

ect c

ervi

cal c

ance

r.

Ong

oing

Ju

n 20

02

Com

plet

e/on

goin

g Ju

n 02

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

70

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

39.

Lette

rs to

Med

ical

Pra

ctiti

oner

s.

Med

ical

pra

ctiti

oner

s ne

ed to

be

rem

inde

d th

at

cerv

ical

sm

ear t

ests

are

not

a m

eans

of

diag

nosi

ng c

ervi

cal c

ance

r. Th

ey n

eed

to b

e al

ert t

o si

gns

of c

ervi

cal c

ance

r, an

d th

ey

shou

ld n

ot p

lace

too

muc

h re

lianc

e on

a

patie

nt�s

sm

ear t

est r

esul

ts to

dis

coun

t the

po

ssib

ility

of c

ervi

cal c

ance

r bei

ng p

rese

nt.

May

200

1 O

ct 2

001

Com

plet

e/on

goin

g D

ec

2001

40.

App

ropr

iate

ly tr

aine

d pe

rson

nel

shou

ld d

o ce

rvic

al s

cree

ning

. Pr

imar

y sc

reen

ing

of c

ervi

cal s

mea

rs s

houl

d on

ly b

e pe

rform

ed b

y in

divi

dual

s w

ho a

re

appr

opria

tely

trai

ned

for t

hat t

ask.

C

onsi

dera

tion

shou

ld b

e gi

ven

to re

quiri

ng

path

olog

ists

to tr

ain

as c

ytos

cree

ners

if th

ey

wan

t to

func

tion

as p

rimar

y sc

reen

ers.

Dec

200

1 D

ec 2

001

Com

men

ced/

ongo

ing

41.

All

path

olog

ists

und

erta

king

cy

tolo

gy s

houl

d be

app

ropr

iate

ly

trai

ned.

If

cyto

logy

is a

sig

nific

ant c

ompo

nent

of a

pa

thol

ogis

t�s p

ract

ice

then

he

or s

he m

ust

parti

cipa

te in

con

tinui

ng m

edic

al e

duca

tion

in

that

sub

ject

.

Dec

200

1 D

ec 2

001

Com

men

ced/

ongo

ing

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

71

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

42.

Cyt

opat

holo

gist

s m

ust p

artic

ipat

e in

con

tinui

ng e

duca

tion

in

cyto

path

olog

y.

If cy

tolo

gy is

a m

ajor

com

pone

nt o

f a

path

olog

ist�s

pra

ctic

e, it

is d

esira

ble

that

he

or

she

shou

ld h

ave

adde

d qu

alifi

catio

ns in

cy

topa

thol

ogy;

eith

er a

fello

wsh

ip s

lant

ed

tow

ards

cyt

opat

holo

gy o

r a d

iplo

ma

in

cyto

path

olog

y. C

onsi

dera

tion

shou

ld b

e gi

ven

to m

akin

g th

is a

man

dato

ry re

quire

men

t.

Dec

200

1 D

ec 2

001

Com

men

ced/

ongo

ing

43.

Path

olog

ists

oug

ht to

be

mor

e op

en-m

inde

d.

Path

olog

ists

sho

uld

be m

ore

open

min

ded

and

criti

cal o

f lab

orat

ory

perfo

rman

ce.

They

sho

uld

be a

lert

to t

he p

ossi

bilit

y th

at t

heir

prac

tice

or

the

prac

tice

of t

heir

colle

ague

s m

ay b

e su

b-op

timal

.

May

200

1 D

ecem

ber 2

001

CSI

Ann

ual R

evie

w 2

001/

02 a

nd A

nnua

l Pla

n 20

02/0

3

N

ovem

ber 2

002

72

Ref

. R

ecom

men

datio

n O

rigin

al

Tim

etab

le A

pril

2001

(C

omm

ence

/ C

ompl

ete)

18

Rev

ised

Tim

etab

le S

ix-

Mon

th R

evie

w

(Com

men

ce/

Com

plet

e)19

Rev

ised

Tim

etab

le

June

200

2 (C

omm

ence

/ C

ompl

ete)

Com

men

t

44.

The

Med

ical

Cou

ncil

shou

ld e

nsur

e th

at s

yste

ms

are

in p

lace

to s

uppo

rt

the

early

repo

rtin

g of

err

ant m

edic

al

prac

titio

ners

by

thei

r col

leag

ues.

Th

e M

edic

al C

ounc

il sh

ould

ens

ure

that

sy

stem

s ar

e in

pla

ce w

here

by m

edic

al

prac

titio

ners

are

not

det

erre

d fro

m re

porti

ng to

it

thei

r con

cern

s ab

out t

he p

ract

ice

of a

n in

divi

dual

med

ical

pra

ctiti

oner

. C

ompl

aina

nts

shou

ld b

e as

sure

d th

at th

eir r

epor

ts w

ill no

t re

sult

in th

em b

eing

pen

alis

ed in

any

way

.

Jun

2002

Ju

n 20

02

20

02/0

3 tim

etab

le

depe

nden

t upo

n le

gisl

ativ

e pr

oces

s th

roug

h H

ouse

.

45.

NC

SP s

houl

d ha

ve a

sys

tem

for

iden

tifyi

ng d

efic

ienc

ies.

Th

e sc

reen

ing

prog

ram

me

shou

ld h

ave

in

plac

e a

syst

em o

ver a

nd a

bove

the

audi

t and

m

onito

ring

repo

rts, t

o id

entif

y de

ficie

ncie

s in

its

proc

ess.

A fo

rm o

f sur

vey

of u

sers

so

that

they

ca

n be

pro

activ

e ra

ther

than

reac

tive

in th

e de

liver

y of

the

prog

ram

me

wou

ld b

e us

eful

.

Ong

oing

O

ngoi

ng

Com

men

ced/

ongo

ing

46.

Ther

e sh

ould

be

a pr

oces

s fo

r m

onito

ring

the

impl

emen

tatio

n of

th

e C

omm

ittee

s R

ecom

men

datio

ns.

A pr

oces

s to

ens

ure

that

the

reco

mm

enda

tions

m

ade

by th

e C

omm

ittee

are

impl

emen

ted

shou

ld b

e pu

t in

plac

e.

Ong

oing

O

ngoi

ng

Com

men

ced/

ongo

ing


73

Appendix 6: Glossary of Common Abbreviations Abbreviation Official Name

BSA BreastScreen Aoteaoroa

CSI Cervical Screening Inquiry

DHB District Health Board

HFA Health Funding Authority

HPCA Heath Practitioners Competence Assurance Bill

IMG Independent Monitoring Group

NHI National Health Index

NCSP National Cervical Screening Programme

NCSP-R National Cervical Screening Programme Register

NEAC National Ethics Advisory Committee

NSU National Screening Unit

NZHIS New Zealand Health Information Services

PHLR Public Health Legislation Review Team

OAG Office of the Controller and Auditor-General

cervical screening inquiry annual review 2001/02 and ...€¦ · • andrew forsyth, team leader,...

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