11.1 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.
11.2 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.
11.3 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.
11.4 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.
11.5 There needs to 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 ensure that the
requisite legal authority to carry out these plans is in place.
11.6 The National Cervical Screening Programme should
be thoroughly evaluated by lawyers to determine whether or not those
persons charged with tasks under the Programme have the necessary
legal authority to discharge them.
11.7 The National Cervical Screening Programme 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 program. these must be remedied in a timely manner
11.8 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.
11.9 The compulsory setting of a minimum number of
smears that should be read 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 laboratory site will process
a minimum of 15,000 gynaecological 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. This should be implemented within 12 months.
11.10 There needs to be a balanced approach, which
recognises the importance of all aspects of the National Cervical
Screening Programme. The emphasis on smear taking and increasing the
numbers of women enrolled on the Programme needs to be adjusted.
11.11 The culture which was developing in the Health
Funding Authority regarding the management of the National Cervical
Screening Programme under the management of Dr Julia Peters needs
to be preserved and encouraged now that the Health Funding Authority
has merged into the new Ministry of Health.
11.12 The National Cervical Screening Programme must
be managed within the Ministry of Health as a separate unit by a manager
who has the power to contract directly with the providers of the Programme
on behalf of the Ministry. The Programme’s delivery should not be
reliant on the generic funding agreements the Ministry makes with
providers of health services. For this purpose the unit will require
its own budget.
11.13 The National Cervical Screening Programme should
be under the control of a second or third tier manager within the
Ministry. The Manager of the unit should as a minimum hold specialist
medical qualifications in public health or epidemiology. As a consequence
of the Programme’s link with the Cartwright Report it has always had
a female national co-ordinator. While there are understandable reasons
for having the Programme managed by a woman it is not necessary for
cervical screening programmes to have female managers. The cervical
screening programme in New South Wales is managed by a male medical
practitioner. The time has arrived for the National Screening Programme
to be treated as a medical programme which is part of a national cancer
control strategy. In the past its link with the Cartwright Report
has at times resulted in its purpose as a cancer control strategy
being compromised for non-medical reasons.
11.14 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.
11.15 There needs to be a reconsideration of the
Kaitiaki Regulations, and the manner in which those regulations currently
affect the Ministry of Health gaining access to aggregate data of
Maori women enrolled on the National Cervical Screening Register.
The Ministry of Health and any appropriately qualified persons engaged
by it (be they independent contractors, agents or employees) 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.
11.16 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 (external
or internal) 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.
11.17 The Health Act 1956 requires amendment to enable
the Ministry of Health and any appropriately qualified persons it
engages to carry out (external or internal) 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.
11.18 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.
11.19 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.
11.20 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 interpretation
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.
11.21 Ethics committees require guidance regarding
the weighing up of harms and benefits in assessing the ethics of observational
studies.
11.22 A national ethics committee should be established
for the assessment of multi-centre or national studies.
11.23 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.
11.24 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.
11.25 The National Cervical Screening Register needs
to be electronically linked with the Cancer Register.
11.26 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.
11.27 Standards for the National Cervical Screening
Programme should be reviewed every two years and more frequently if
monitoring indicates that some of the standards are inappropriate.
11.28 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.
11.29 The Medical Laboratory Technologists 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
11.30 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.
11.31 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.
11.32 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
11.33 The National Cervical Screening Programme should
work towards developing a population based register and move away
from being the utility based register that it now is.
11.34 There should be a legal obligation on the Accident
Compensation Corporation, the Medical Council and the Health and Disability
Commissioner to advise the National Cervical Screening Programme’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.
11.35 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 Minister
of Health.
11.36 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.
11.37 It is recommended that the Programme liase
with the Royal College of Pathologists of Australia. In its submissions
the Royal College advised that it believed that the collaborative
relationship the college had with the Federal Government in Australia
might be a model worth consideration by the Inquiry. It was suggested
that it was appropriate to use medical colleges as an over-arching
body to provide advice on issues. The benefit of this is, if the College
is asked to provide an opinion on issues such as professional practice,
quality or standards, it has access to the views from multiple professionals
and also a critical evaluation of current literature in contemporary
standard practices. It is suggested that the National Cervical Screening
Programme, which has achieved a great deal, would benefit from greater
professional input at a College level. In particular, it is suggested
that a National Cervical Cancer Register and a Cervical Cancer Mortality
Review process be a means of continually evaluating the Programme’s
effectiveness. The Committee supports the College’s submission and
recommends that it be acted upon.
11.38 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.
11.39 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.
11.40 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.
11.41 If cytology is a significant component of a
pathologist’s practice then he or she must participate in continuing
medical education in that subject.
11.42 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.
11.43 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.
11.44 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.
11.45 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
11.46 A process to ensure that the recommendations
made by the Committee are implemented should be put in place.
