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Great new cervical screening resource
for women

The new detailed booklet for the National Cervical Screening Programme provides comprehensive information for women on cervical screening, all written in easy language, with diagrams and glossary. It covers how cervical screening is done, the benefits of 3-yearly screening, who should have smear tests, the effectiveness of smears, how to get results, what they mean, colposcopy, treatment, the programme and cervical cancer. To get copies ring the NCSP 0800 729 729

 

 

 

Manitoba launches Cervical Cancer Screening Program

The provincial government has officially launched the Manitoba Cervical Cancer Screening Program. CancerCare Manitoba will deliver the program on behalf of Manitoba Health. This program will support prevention of cervical cancer through education and the establishment of a registry. CancerCare Manitoba is coordinating a public information campaign through a television ad, the distribution of information brochures in nine languages, an education resource kit for community educators and a Web site. http://www.cwhn.ca/hot/research/default.html

3 October 2001 Media Statement

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 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.

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.

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.

Supplied by Ministry of Health October 2001

Law changes for auditing the National Cervcal Screening Programme:
How far should they go?

Sandra Coney, Executive Director, Women's Health Action Trust
Email: coneys@womens-health.org.nz
Phone: 09 520 5295, Fax: 09 520 5731
PO Box 9947 Newmarket Auckland

In early June the Government released a 'discussion document' on proposed law changes to enable auditing of the National Cervical Screening Programme entitled Improving the National Cervical Screening Programme: Law changes to enable effective audit of the programme.

The law changes propose access to personal health information without the individual woman's consent. This follows recommendations contained in the Gisborne report.

Auditing is an essential part of the evaluation of the NCSP. It involves looking at the medical histories of women who have been diagnosed with cancer to see why the programme has not prevented it. There are five broad possibilities that are looked at:

  • She was not having smears
  • Her smear history was out-of-date
  • Her smears were wrongly read (false negatives)
  • Once she had an abnormal smear, it was not adequately followed up (for example, delays in colpsocopy)
  • Failure of treatment.

Finding out how cases of cancer have occurred will allow improvements to be made in the programme. This will enable the programme to operate at its maximum effectiveness and thus bring about a reduction in cases of, and deaths from, cervical cancer.

Audit can also involve looking at the medical histories of women with high-grade cervical abnormalities who are referred for colposcopy.

1. What the discussion document says

Although the document lacks explicitness about what is proposed, the intent is sweeping. The new law would allow a wide range of information to be made available to auditors without women's consent.

Personal information about women would be sought from:

  • National Cervical Screening Programme Register
  • Cancer Registry (already allowed by law)
  • Slides held by laboratories
  • Clinical records held by
    • Doctors eg GPs, Family Planning
    • Nurses
    • Specialists
    • Hospitals.

Information would be sought about:

  • Women diagnosed with cancer
  • Women who have been referred for colposcopy because of abnormal smears

The law would affect:

  • Women whose names are on the NCSP register
  • Women who have 'opted off' the register or who are not on it for any reason
  • Maori women who information is currently protected by Kaitiaki regulations

The 'discussion document' does not contain detail about what kind of audit is proposed. The plans for these have not been made, so no rationale is provided as to why such a sweeping approach is needed. It's a kind of 'let's make sure we can access everything if we ever want to' approach with is at odds with the principles of the Health Information Privacy Code. That Code says that people should be told what has been collected and for what purpose, which implies a specificity about the intent of collection that is lacking from the current plan.

The Code also says that clinical information can be disclosed where the individual woman has consented, but that if gaining consent is 'undesirable or impractical' the health professional who holds the records can disclose the records for audit. Whether consent is undesirable or impractical is covered in the discussion below.

The Government proposal also over-rides the Code of Health Consumers' Rights which emphasises informed consent.

2. Consent to accessing personal information for audit

This needs to be looked at under the headings above for different locations of the information sought.

National Cervical Screening Programme Register

The current law requires women to be given the chance to 'opt off' the register, therefore we could assume that women have made a conscious decision to put their names and information on the register. The move to 'opt off' in 1993 was in part to enable monitoring and evaluation, of which audit is a part. Hopefully, most women on the register know this and would have no objections to their information being audited without the need for specific consent.

Slides held by laboratories

As the information on the register is derived from the slides held by labs, it is hard to see that women would object to these been reviewed.

There might be privacy issues for women who have 'opted off' the register, and there is a related issue of whether women should be told of misread slides discovered during audit. Clearly they should be told if this error discloses a need for the woman to be followed up, but should they be told in other cases? Even the best of programmes will have a percentage of misread smears. In the recent Leicester Review in the UK, the Department of Health decided to tell woman of any errors that were turned up and this is seen as setting a precedent that must be considered.

Clinical records

The audit would involve going to all those providers who held information about a particular woman (women might have had smears by a number of different providers). This is the most contentious area, especially for those records (GP and Family Planning) that contain information about areas other than cervical screening.

The question is: Would women want to be consulted before their health care givers allowed auditors to look at files?

The Royal Australasian College of GPs has expressed qualms about this and has said that members would only hand over information related to cervical smears and cervical cancer.

However, auditors say that this would not work. An issue that arose at Gisborne, was the number of GPs who had relied on clear smears tests, even when women reported symptoms of cancer (such as bleeding between periods or after sex) that should have been followed up regardless of the smear results. Isn't it likely that if GPs extract the information, some at least would not pass on information that pointed to their poor management?

Another argument in favour of a law is that it would compel doctors to make records available, about which they might otherwise be reluctant. A countervailing argument is that doctors cannot be compelled to comply by legislation and it is unlikely that health authorities would use the courts to enforce this.

When it comes to hospital records, women might accept not being asked, if the records disclosed are confined to those relating to abnormal smear follow-up. It has not been made clear whether only these, or all hospital records would be required.

3. Kaitiaki regulations

Current regulations require the consent of the National Kaitiaki Group to access Maori women's data from the screening register. The proposal plans to amend the law so that this information can be used by auditors without the approval of the National Kaitiaki Group.

4. Do all these categories of records need to be accessed?

Audits can be carried out in varying ways. It would be quite possible, for instance, to conduct one type of audit looking only at the National Cervical Screening Register and slides. Another might add treatment records held by hospitals. Yet another might go to the level of including GP records and/or interviewing women.

Those planning the audit can decide how widely an audit extends. The more extensive the audit, the greater the amount of information that will be available to those implementing the programme.

5. Why not gain consent to accessing clinical files?

For an audit to be statistically valid it must include as complete as possible collection of cases. It has been argued that if women are asked, some will refuse, and this might undermine the ability to conduct a meaningful audit.

The claim that some women might refuse consent is the basis for not seeking it, yet no information has been provided on cases where individuals have refused permission during audits, or in what proportion of cases this might occur.

The approach proposed in the discussion document differs from what had previously been planned. In the protocol for the cervical cancer audit, the Otago University team intended to gain consent. No explanation has been given for the change in approach by the Government.

There are a number of examples where, up to now, external auditors have sought and gained consent. A review of cases of Maori women who developed cervical cancer carried out by researchers at Otago University involved approaching women for consent to look at GP records (Ratima et al, 1993). All the women consented. In another study of men with prostate cancer this approach has also proved successful.

In many cases, the audit team will want to interview the woman herself. She may be affronted if she learns that the auditors have already seen her medical files without her knowledge.

The other reason for not seeking consent is that women may have moved and be unable to be traced. Once again, no information is provided as to how often this is expected to occur. If audits are conducted regularly, it is unlikely that women would be lost.

At the Gisborne Inquiry, Women's Health Action advocated that women who might be followed up as part of an audit could be provided with information about this around the time of diagnosis. This would inform women of the process and prepare them for an approach. Women could also be asked to ensure that they keep their contact details on the National Cervical Screening Programme register up to date.

6. The current government proposal

The current proposal is being driven by Government. It is not led by the National Screening Unit.

The Government has committed itself to carrying through the recommendations of the Gisborne Report although the current proposal goes further.

It is not clear who has been consulted during the preparation of the proposal. When Women's Health Action saw an early version of the consultation document, and the consultation plan, we expressed our concerns to the Minister of Health in no uncertain terms. Following this we had some dialogue and even a meeting with the Ministry of Health in January at which it became clear that the Ministry was not clear what it planned in the way of an audit, and that it had not consulted with GPs.

Next we were cut out of the consultation, having stated our fears about fundamental aspects of the approach.

It is arguable that the Government needs to go as far as it is proposing in allowing auditors to access to women's records without consent. Despite this, press releases from Mrs King make clear that the legislation will happen. The 'discussion document' is not a 'consultation' and you will not find that word found in it. It is to 'inform' women and seek their views. There is no commitment to listen to those views or make changes.

We have concerns about the lack of explicitness in the document, especially as it deals with a complex, difficult area of healthcare monitoring which few consumers will know about.

The timeframe is a mere six weeks, and apart from Maori and Pacific women, there are no plans for face-to-face meetings at which women might raise concerns and ask questions. Once again, as this is a difficult area, women might have welcomed such dialogue.

The National Cervical Screening Programme relies on women's and doctors' support and confidence. The outcome of this initiative is of vital interest to the future of the cervical screening programme. The way must be cleared for an effective audit, but the price must not be the alienation of women and their caregivers. Such a result would be supremely counter-productive.

To obtain a copy of the discussion document look on www.moh.govt.nz.

Closing date for submissions is Monday 16 July 2001.

Ref: Ratima et al, 1993. Cervical smear histories of Maori women developing invasive cervical cancer. New Zealand Medical Journal 106:519-21