8.1 The Government has agreed to look at legislative
change to allow monitoring and evaluation of the Programme to be carried
out without the hindrance of the legal obstacles which presently prevent
this valuable exercise from being undertaken. However, in the Committee’s
view the proposals it has seen do not go far enough, especially given
the period of time which has already elapsed. There is the potential
for the proposed change to become bogged down in long consultation
and attempts to reach a consensus view on an issue which does not
lend itself to a solution which is likely to be amenable to all interest
groups. For this reason the Committee considers that in their present
form the proposed changes can not be described as something which
will further address any risks of under-reporting of abnormal smears.
It, therefore has considered the legislative proposals under term
of reference six.
8.2 The national evaluation which was to be carried
out by an independent team, and which was unable to be performed due
to difficulty in accessing information, has now been taken over by
Dr Peters and the unit within the Ministry which is responsible
for the Programme. It is believed that by carrying the project out
as an internal audit the problems that the independent evaluation
team encountered in gaining access to protected information will be
avoided. The Committee has been told that the project is complex and
it could take up to seven months to complete preparatory work. Dr Peters
advises the Committee that she acknowledges previous work has been
done on the project, but she says much work now needs to be done to
ensure that the complications that have previously arisen do not impede
the project in the future. Whether or not this new plan to gain access
to much-needed information actually works, is still to be seen.
Proposed Changes To The Operation Of The National
Cervical Screening Programme
8.3 When the National Cervical Screening Programme
moved to the Health Funding Authority it came under the control of
Dr Julia Peters, a specialist in public health. Since the incident
of under-reporting in the Gisborne region has surfaced considerable
effort has gone into improving the National Cervical Screening Programme’s
effectiveness. She is the person responsible for managing the National
Screening Team.
8.4 New policies and quality standards for the Programme
were developed. These were produced in draft form to the Committee
during the Inquiry hearings. The Committee found these draft documents
impressive. Expert witnesses commented on them favourably. Since the
conclusion of the public hearings the Committee has received affidavit
evidence from Dr Peters to update it on further progress. It has learnt
that National Cervical Screening Policy Interim Operation Policy
and Quality Standards October 2000 has now been finalised. The
Committee’s view is that the policies and quality standards, which
this document contains, must be implemented as a matter of urgency.
Every support should be given to Dr Peters and her team to ensure
that the Interim Operation Policy is put into action. In the
Committee’s view the implementation of this document will do much
to improve the effectiveness of the Programme.
8.5 In her affidavit Dr Peters described the current
members of her team. The team comprised a permanent staff allocation
of 7.5 fulltime equivalent staff, four fulltime fixed term contractors
and approximately 6.5 fulltime equivalent consultants. She had recently
received approval from her general manager to appoint a finance manager
and an information technology manager to the team. They would be permanent
appointments. She had also received approval to appoint an additional
staff member for the National Cervical Screening Register. The Committee
learnt that she had advised her manager that a significant number
of additional staff with clinical epidemiological public health contracting
and quality assurance and monitoring skills were also required in
the team. The Committee supports Dr Peters’ views on this point.
While advisory groups can be of assistance, it is essential that the
Programme has its own in-house qualified personnel. Epidemiological
public health skills, contracting skills and quality assurance and
monitoring skills all relate to areas where in the past, the Programme
has been found wanting. The lessons to be learned from the last decade
are that reliance on advisory groups cannot provide the same input
that persons with these qualifications can if employed by the Programme.
Furthermore the Committee’s views are consistent with the views expressed
by the Cervical Screening Advisory Committee in its final report in
1994 to the Minister. In that report the Committee emphasised the
importance to the Programme of skilled staff including epidemiologists
and biostatisticians.
8.6 It is clear from the evidence that between July
1998 to June 2000 there were no specific performance measures for
the Programme while it was with the Health Funding Authority. The
impetus that the experience at Gisborne gave to the Health Funding
Authority must be continued. It is important that the Programme receive
all the resources that Dr Peters believes essential for it to operate
effectively.
8.7 Dr Peters also advised the Committee that by
23 November 2000 the national laboratory contract has been completed
and signed by all 12 community laboratories. It makes compliance with
the National Cervical Screening Policy Interim Operational Policy
and Quality Standards October 2000 and the IANZ Quality and
Services Standards for Medical Testing Laboratories a contractual
requirement. The IANZ Quality and Services Standards for Medical
Testing Laboratories are included in the contract as an appendix.
In the Committee’s view the national laboratory contract will go a
long way to ensuring quality performance of laboratories.
8.8 The Committee was advised that there has been
a policy decision to impose three minimum volume standards on laboratories.
These are: each fixed laboratory site will process a minimum of 15,000
gynaecology cytology cases; each pathologist will report at least
500 abnormal gynaecological cytology cases, cytotechnical staff must
primary screen a minimum of 3,000 gynaecological cytology cases per
annum. In the Committee’s view these minimum standards must be implemented.
It considers them to be good, however it notes that Dr Peters
envisaged that during the next eight months the national screening
team would be working with all relevant parties to ensure transition
issues are appropriately managed. It is important that the minimum
volume standards be imposed within six months. Minimum standards were
first suggested a decade ago.
8.9 The Committee notes that an independent monitoring
and audit group for the Programme is to be appointed. The Committee
supports this. A contract has been agreed between the University of
Otago and the Health Funding Authority for the establishment of a
National Cervical Screening Programme Independent Monitoring Group.
The first quantitative monitoring for the Programme against the national
indicators in the Operational Policy and Quality Standards Manual
is to commence using data from women screened from 1 October to
30 January 2000. Reporting on this data is due in April 2001. The
Committee supports this and considers that it must go ahead. An independent
monitoring group is vital for the Programme’s effectiveness. It is
also important that this group get full access to the information
it needs to enable the monitoring exercise to be carried out. The
progress of the audit and whether or not it reports by April 2001
need to be watched.
8.10 The Committee also considers that thought needs
to be given to the European Guidelines on Cervical Screening with
a view to seeing whether or not those parts of the Guidelines that
are still not included in the Operational Policy and Quality Standards
Manual should be included. During the Inquiry the Committee heard
from Dr Cox who was very supportive of all the monitoring criteria
in the European Guidelines. The Committee is aware that these Guidelines
are not in operation in a number of European countries, however that
does not detract from their value.
8.11 Dr Peters advised that she was also considering
what processes would be required to establish a successful audit of
the Programme. She noted that there needed to be: a comprehensive
audit framework for the Programme; customised audit for specific provider
groups; a comprehensive pre-audit data collection process was required;
auditors would need to be independent and appropriately trained; full
audit reports would need to be provided; the national screening team
will need to develop processes to address all issues revealed at audit.
Added to this should be the qualification that the Programme should
ensure that the auditors will not encounter any legal obstacles in
carrying out the exercise. It is important that these audits are carried
out.
8.12 Dr Peters has advised the Committee that
from 1 July 2001 the National Screening Team will have operational,
contractual and financial responsibility for the Programme. She said
that a National Cervical Screening Programme unbundling and financial
model had been developed and agreed within the Health Funding Authority
and the financial transfer approved. The Committee supports this entirely.
It recommends that by 1 July 2001 the Programme should be in
a position where it has complete responsibility for the operational
contractual and financial management within the team responsible for
it (national screening team).
8.13 Dr Peters’ evidence was that there is a
move towards centralisation of all national aspects of the Breast
Cancer Screening Programme and the National Cervical Screening Programme
and development of quality assurance processes within both programmes.
The Committee has been advised that a separate national screening
unit has been formed and the structure was approved by the Director-General
of Health on 7 November 2000. This unit will be staffed by 33
fulltime equivalent staff and will undertake all the functions necessary
for the national management of the two cancer screening programmes.
There will be six teams, namely Information Management, Contracts
and Finance, Maori Screening and Development, Breast Screen Aotearoa,
National Cervical Screening Programme, Quality Monitoring Analysis
and Audit. The most senior appointee will report to the Deputy Director-General
of Public Health. There will be a clinical director who will be a
public health medicine specialist, and ideally the two managers of
the National Cervical Screening Programme and the Breast Screen Aotearoa
will also be public health medicine specialists. Provision has also
been made to appoint a part time epidemiologist to the quality monitoring
analysis and audit team. A number of part time consulting clinical
experts will also be appointed. Dr Peters outlined the advantage
of the structure as being :
It delivered internationally recognised key organisational
components for successful screening programmes;
It provided clear reporting structures with a reasonable
span of control for managers;
Its current reliance on contractors for critical
positions will cease;
It provides professional development and management
within an individual’s chosen career, thus providing a strong platform
for recruitment and retention of quality staff;
The model is sustainable across a range of scenarios,
for example differing health service configurations;
It established an experienced base and benchmarks
which can be built onto should other national screening programmes
be developed.
8.14 Dr Peters advised that all current term
and national screening team staff will be confirmed in positions within
the new national screening unit. Development of detailed position
descriptions has commenced and recruitment for vacant positions will
commence as soon as these are finalised. The Committee agrees with
these plans. It considers that the National Cervical Screening Programme
should be run through a centralised management system. The fragmentation
that resulted from the earlier models under the area health board
and later regional health authority system was detrimental to the
Programme. A Programme of this nature is best run as a national programme
from a centralised office. It is particularly important that with
the current restructuring of the health sector and the use of 22 district
health boards ( something on which the Committee has received no updating
evidence) the Programme should not be subject to the threat of any
further fragmentation.
8.15 The Committee considers that the changes that
have come about as a result of the Gisborne incident bode well for
the Programme. It should be a much better programme. It is unfortunate
that it took a tragedy to bring this about. Many of the changes that
are now being implemented were recommended when the Programme was
being established.
