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Women on Screening Programme Changes

22 February 2005

One Million Letters to Women on Screening Programme Changes

The first of more than one million letters have been sent to women on the National Cervical Screening Programme informing them about changes to the programme coming into effect next month to improve its quality, safety and effectiveness.

The changes result from the passing of a new law, the Health (National Cervical Screening Programme) Amendment Act, which addresses several issues raised from the 2001 Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne region, including barriers to effectively evaluating the Programme.

NCSP Clinical Leader Dr Hazel Lewis says the letter-writing operation will also help ensure that the register has up-to-date address details. She says keeping track of more than a million women, when on average more than 140,000 of them shift house each year, is not as straightforward as it looks.

"We fully expect some women who are enrolled on the programme won't receive our letter because we'll have the wrong address for them. Any woman, who is getting cervical smears and who hasn't received a letter by the end of this week, should ring our freephone 0800 729 729 to update their details and also to discuss any concerns they may have about the law change or the programme."

A key purpose of the law change is to improve the operation and evaluation of the National Cervical Screening Programme (NCSP), to ensure its safety and effectiveness for women. The Act sets out objectives for the NCSP and provides for the appointment of experts (called Evaluators) to assess the performance and safety of the Programme by ensuring they have access to key information.

A decision to write to more than a million women enrolled on the NCSP-Register was reached in consultation with the health select committee, consumer groups and the screening unit's consumer reference group, which includes several women's organisations. The letter informs women about the changes and how they will affect them. Information packs will also be sent to health centres throughout the country.

The recent Cervical Cancer Audit found that, overall, women and health professionals can have confidence in the services provided by the NCSP and should be encouraged to participate in it. Since the National Cervical Screening Programme began there has been a reduction in the number of women who develop cervical cancer of about 40 percent and a reduction in deaths from cervical cancer of about 60 percent.

More information can be found at:


How many women will be sent this letter? The letter is being individually addressed to just over a million women. These are all the women who are considered to be enrolled on the Programme.

Where did the contact details come from for this letter? The women-€™s details are stored on the Programmes computers system (NCSP-Register) and are the contact details recorded at the woman-€™s most recent smear, unless they have subsequently provided updated details.

Why will some women receive the letter when they haven't chosen to be on the programme? All women who have smears are automatically enrolled on the Programme unless they said they didn-€™t want to be. A lot of women may not be aware they are on the Programme as the only contact they receive is a letter welcoming them to the Programme, a letter when they are overdue for a smear or have a smear that is not normal. The new legislation places obligations on smear takers and the Programme to make sure women have access to the information they need to make an informed decision as to whether they wish to take part in the Programme.

There are some women who have "opted off" individual smears in the past. Unless a formal request has been made to withdraw from the NCSP-Register, then these women may still be enrolled on the Programme. The new legislation changes allow women to withdraw from the Programme completely rather than -"opting off" individual smear results.

Why was the new Act needed? The National Cervical Screening Programme was established in 1990 to reduce the rates of and deaths from cervical cancer through a nation-wide ongoing organised screening programme that would detect the majority of cases in the early pre-cancerous curable stage.

In 1999 a Ministerial Inquiry was ordered into the apparent under-reporting of abnormal smears in the Gisborne region (the Gisborne Cervical Screening Inquiry) and to inquire whether there was evidence of wider systemic issues for the National Cervical Screening Programme to address to improve the safety and effectiveness of the Programme.

The Inquiry recommended that legislative change be made to the Health Act 1956 in order to remove legislative barriers that hinder the comprehensive evaluation of the National Cervical Screening Programme. The current system has significant barriers to effective and efficient evaluation of the Programme because the information required for evaluation cannot be adequately collected or is difficult to access.

Much of the information that needs to be accessed for evaluation purposes is currently subject to requirements of consent or authorisation from the woman herself, and is released at the discretion of the woman's health practitioner. The Cervical Screening Inquiry found that this causes practical and technical problems, for example some women are not easily traceable. For the results of an evaluation to be statistically meaningful, and therefore provide information on areas in the NCSP that may need to be strengthened, the evaluation must cover a sufficiently large proportion of the identified sample of women. What are the aims of the Act? The purpose of the Act is to reduce the incidence and mortality of cervical cancer through the effective operation of the NCSP and to facilitate the evaluation of the Programme.

The Act aims to streamline and clarify how the National Cervical Screening Programme works and what its objectives are. It will also enable experts (called Evaluators) to assess the performance and safety of the Programme by ensuring they have access to key information.

How does this compare to the current national cervical screening programme? Under the Health (National Cervical Screening Programme) Amendment Act 2004 the following changes are being made: making it clear how the cervical screening programme works and what the responsibilities are for everyone involved in it making sure women get all the information they need to know about the cervical screening programme, including their option to withdraw from it recording and monitoring of all cervical smear results except for those women who withdraw from the programme the cervical screening programme will be able to be fully evaluated to help make sure it is safe and to make improvements there will be regular external independent review of the cervical screening programme

The Act provides for screening programme evaluators, why are they necessary? For the purposes of the Health (NCSP) Amendment Act, evaluation refers to the: -· Assessment of the service delivery and outcomes of the Programme -· Identification of systemic issues -· Identification of areas where quality improvements could be made.

The term evaluation covers a wide range of activities - from routine (perhaps daily) monitoring of statistical evaluations data to less frequent evaluations looking into cases of cervical cancer, such as the current audit of invasive cervical cancer.

Evaluation is an important quality management tool of the NCSP as it provides information to allow the Programme to be operated in a safe and effective manner. Evaluation is different to academic research. The importance of evaluation to the NCSP was clearly stated in the Gisborne Cervical Screening Inquiry, and has also been identified by the National Health Committee in Screening to Improve Health in New Zealand (2002) as a key aspect of the screening pathway. Who are the evaluators? Under the Act the Director-General of Health can designate screening programme evaluators. Evaluators may be employees of the Ministry of Health or external to the Ministry. They will need to have the technical competence to undertake an evaluation.

What information can they access? Evaluators will only be allowed to access the information necessary for the evaluation they are conducting. This may include access to the NCSP“Register information, specimens and health information held by laboratories, hospitals and/or health practitioners. Access to these records was recommended in the Gisborne Cervical Screening Inquiry. For example, recommendation 11.17 states: 'The Health Act 1956 requires amendment to enable the Ministry of Health and any appropriately qualified person it engages to carry out (external or internal) audit, monitoring or evaluation of cervical cancer incidence and mortality to have ready access to all medical files recording the treatment of cervical cancer by all health providers who had a role in such treatment'.

Recognising the potentially sensitive nature of some of the information evaluators may need to access, the Act provides for health practitioners, such as GPs to oversee evaluators access to records they hold.

Will information obtained by the evaluators be made public? Under the Act it is both an objective of the NCSP and a duty of the Director General of Health to provide information to the public on the quality and effectiveness of the NCSP. This may include, if it is appropriate, non-identifiable information based on the results of evaluations.

What safeguards are in place to ensure women's health information will be treated appropriately by the evaluators? The Act places very strong confidentiality requirements on screening programme evaluators (clause 112X(1) states "No screening programme evaluator may use or disclose any evaluation material for a purpose other than performing that person's functions as a screening programme evaluator'. To fail to comply with this requirement is an offence under the Act).

There are also requirements on evaluators to take appropriate measures to safeguard all evaluation material from inappropriate use or disclosure, to return all evaluation material as soon as it is no longer required for the evaluation, and to preserve the physical integrity of all specimens.

What happens if evaluators do not keep personal information confidential and secure? The Act places strict conditions on evaluators to ensure the information used for evaluation purposes is kept secure and confidential. Any breach of these provisions will be an offence under the Act and could result in penalties.

How does the Act affect access to women's health information? The Act places clear obligations on smear takers, colposcopists and the Programme to advise women on the Programme that their records may be used for evaluation purposes. It also allows evaluators to access the health information of relevant women without first seeking their additional consent. A relevant woman is one who: -· is enrolled on the NCSP -· has developed cervical cancer, or -· is deceased, but at the time of death was either enrolled on the NCSP or has had developed cervical cancer.

The records of women who have withdrawn from the Programme and have not developed cervical cancer will not be able to be accessed automatically, and procedures set out in the Health Information Privacy Code will need to be followed to access their health information.

What safeguards are in place in the Act to ensure women's health information is confidential and secure? There are obligations on the NCSP to not disclose information held on the NCSP-Register, except in a number of limited situations. These include: -· for the purpose of enabling results to be followed up -· for sending reminder notices to women on the Programme to a screening programme evaluator -· for evaluation purposes, and -· or with the consent of the woman or her personal representative.

There are also strict obligations on evaluators. Evaluators can only access information for the purpose of evaluation and to the extent that the information is relevant to the evaluation (discussed above). The Director-General can also limit access to certain information and regulations can be made to limit access to certain information. There are provisions in the Act to ensure that women are made aware both by their smear taker and by the NCSP on how their health information will be used.

When a woman decides to participate in the National Cervical Screening Programme, both the smear taker and the Programme are required to inform her what information is collected and for what purpose. The Programme will also inform her that information about her may be used for the purposes of evaluating the Programme. That information may include: -· information on the NCSP-Register -· laboratory slides/results -· hospital records -· private specialists records -· primary care records.

What happens if a woman wants to withdraw from the programme? Prior to the law change, each time a woman had a smear she could choose if a copy of the result would be recorded on the NCSP-Register. Choosing to not have a particular smear result recorded on the NCSP-Register is called 'opting off'. To opt off that result means that the NCSP-Register has an incomplete record of the woman's screening history.

Under the new law, women can no longer opt off individual smear results. Instead she can choose to withdraw from the entire cervical screening programme. If she chooses to do this, all her screening history will be removed from the NCSP-Register. This will mean that for women who have cancelled their enrolment in the Programme, no information (except the minimum necessary for identifying her as being a woman who has opted-off the Programme) will be recorded by the NCSP. It also means that there will be no one place where all of the woman's cervical cytology and histology results will be recorded.

What if a woman wants to re-enrol on the programme? A woman who has withdrawn from the Programme can re-enrol at any time by completing a ˜Re-enrol in the Programme' form or writing to the Programme.

If a woman withdraws and then re-enrols some years later, her smear history will start from that date.


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