Media Statement

3 October 2001

Cabinet supports law changes to assist audit of national cervical screening programme

Health Minister Annette King says the Government has given the go-ahead to proposed new law changes to implement key recommendations of the Gisborne Cervical Screening Inquiry.

Mrs King says the Cabinet has approved changes to legislation to support the monitoring, audit and evaluation of the National Cervical Screening Programme (NCSP), following the receipt of 101 submissions on proposed changes to Section 74A of the Health Act 1956.

The changes would allow information from the NCSP Register to be available for the purpose of monitoring, auditing and evaluating the effectiveness of the programme, she said. "The changes also include provision for women to 'opt off' the programme completely, ensuring their register information is not used if they so choose.

"Under strict security guidelines, selected auditors will be able to access identifiable information held on the Register for auditing the programme. Auditors will be required to keep all personal information confidential and secure.

"I believe women will see the benefits of remaining on the programme. With the new consent arrangements for accessing clinical records in place, and in light of the emphasis the Gisborne inquiry gave to the obvious need for monitoring, auditing and evaluation, it is unlikely many women will leave the programme.

"The changes will meet several key recommendations of the Gisborne report, but consent will still need to be sought to access clinical records of women. As part of an audit of women with invasive cervical cancer, those who have opted off the programme may also be contacted for consent to clinical records," Mrs King said.

"The message in submissions was clear. Three-quarters of submissions (74 percent) were opposed to giving access to clinical records without consent. Accordingly we have developed a process which recognises these concerns while giving us the best possible framework for conducting effective programme monitoring, audit and evaluation. The Cabinet has accepted this process."

Mrs King said the Gisborne report in April called the changes to the legislation 'by far the most important change which is required to make the National Cervical Screening Programme fully effective'.

"But it was important to take into account the strong views among consumer and women's groups and some health professionals who were against the proposal.

"There has been significant progress in strengthening the National Cervical Screening Programme in the past two years. These changes will improve the legislative base on which the programme is built, in turn providing the best programme possible for New Zealand women, taking into account privacy concerns over access to clinical records."

The changes to section 74A of the Health Act are intended to be included as part of a comprehensive bill which will address a number of safety and quality issues across the health sector.

The changes will not effect information on the NCSP Register relating to Maori women, which is managed by the National Kaitiaki Group. Preparations have begun for a consultation process on the Kaitiaki regulations, which will take place with Maori women and their families early in 2002.

Steady progress is continuing to be made in implementing the recommendations of the Gisborne Inquiry. The fifth monthly report by the Ministry of Health is now available on the Inquiry website (www.csi.org.nz).

Background information attached. For more information, contact Dionne Barton (04) 470 6851. Copies of the cabinet paper and cabinet minute can be found at website address: http://www.executive.govt.nz/minister/king/

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Background Information on Changes to Section 74A of the Health Act 1956

Why should women participate in the National Cervical Screening Programme?

Unlike most cancers the most common type of cervical cancer - squamous cell carcinoma - is largely preventable. Cells in the cervix go through changes, which if not detected and treated may develop into cervical cancer in some women. Cervical cancer takes on average 10-15 years to develop.

A cervical smear test can detect changes in the cells of the cervix. The success rate for adequate treatment of abnormal cervical cells, also called pre-cancerous changes, is around 98 per cent effective. As with all screening tests there is a small chance that some abnormalities may not be detected at a single screen. This is why it is important to have regular three-yearly cervical smear tests.

For women enrolled on the Programme all of their smear results will be stored on the NCSP-Register, giving a more complete screening history. In addition the Register will provide recall notices when she is overdue for smear tests, and more accurate information will be available to evaluate, monitor and audit the NCSP, as recommended by the Gisborne Ministerial Committee of Inquiry.

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Future Arrangements

Will consent be sought before data held on the NCSP-Register is used for monitoring, audit and evaluation?

When a woman decides to participate in the NCSP, she will be fully informed that her data could be used for audit, evaluation and monitoring purposes.

By joining the programme she has given consent to her data being used for audit, evaluation and monitoring purposes and no specific consent will be sought.

Will information that is used for audit, monitoring and evaluation be kept secure and confidential?

Yes. The Health Act will be amended so that conditions of security and confidentiality are placed on all identifiable information used for the purpose of audit, monitoring and evaluation. Any breach of these provisions will be a breach of the Act and result in penalties.

What will happen if a woman opts-off the NCSP?

A woman can choose to completely opt off the Programme at any time. If a woman chooses to opt off the programme, all her screening history will be removed from the NCSP Register. This will mean that for women who have opted off the programme no data from the NCSP-Register will be available for audit, monitoring and evaluation purposes.

However, if a woman who has opted off the NCSP does go on to develop invasive cervical cancer, and it is decided that she should be included in an audit, she would be approached to give consent to her medical records being used in an audit of invasive cervical cancers (see below).

What will happen if clinical records are needed for an audit of invasive cervical cancers?

If a woman has invasive cervical cancer, and her records are needed for an audit, informed consent will be sought either at the time the woman is registered on the Cancer Registry as having cancer, or at the time of treatment. The Ministry of Health will be consulting with relevant professional groups and women's groups to develop appropriate protocols for seeking consent.

Where a woman has given consent to her medical records being used, the health agency that holds the records will be required to release them. Consent will be sought for women with invasive cervical cancer whether they are on the NCSP or have chosen to opt off the programme.

Will women be told the results of an audit of invasive cervical cancers?

Women will be informed of any adverse findings identified for audit, evaluation and monitoring activities, unless they have indicated that they do not wish to be informed.

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Current Situation

For the approximately 400 women who will be involved in the current audit of invasive cervical cancers consent will be sought to use both data off the NCSP Register and clinical records.

What will happen when a woman has died and her records are needed for an audit of invasive cervical cancers?

Where a woman with invasive cervical cancer has died, and it is unclear whether she has consented to her records being used or not, reasonable attempts to trace her next of kin will be made, in order to seek consent.

What will happen if a woman cannot be traced, or her next of kin cannot be traced?

Where consent is unable to be obtained because the woman cannot be traced, or her next of kin cannot be traced, the Director-General of Health will be able to require the persons who hold the information to release the data.

When implemented how will the changes to the Health Act affect the current audit of the National Cervical Screening Programme?

The proposed changes won't affect the current audit of the NCSP. The current audit is taking place under present legislation and will not require the proposed changes becoming law in order for completion. Undertaking the audit under current legislation has affected the scope and duration of the audit. In addition there have been difficulties accessing information for the current audit.

When implemented how will the changes to the Health Act affect future audits of the National Cervical Screening Programme?

The changes to the Health Act will mean that future audits will be able to be carried out more regularly, and efficiently. Random re-reads of slides and evaluation exercises using the NCSP-Register data will be able to be carried out as a matter of course to ensure that services are being delivered effectively.

The changes also mean that where a woman has consented to her clinical records being used, the health agency that holds the records will be required to release them. In total, the changes will mean that the information that is needed to audit, monitor and evaluate the NCSP will be made available, resulting in a more effective programme for New Zealand women.