Health (National Cervical Screening Programme) Amendment Act Questions and Answers
1 Why was the new Act needed?
The National Cervical Screening Programme was the first organised cancer screening programme in New Zealand. It 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 the then-Minister of Health ordered an Inquiry (the Gisborne Cervical Screening Inquiry) into the apparent under-reporting of abnormal smears in the Gisborne region 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 Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region 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.
2 What are the aims of the Act?
The Health (National Cervical Screening Programme) Amendment Act replaces section 74A of the Health Act 1956, which established the National Cervical Screening Register.
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 and will enable experts (called Evaluators) to assess the performance and safety of the Programme by ensuring they have access to key information.
The Act also meets four specific Gisborne Cervical Screening Inquiry Recommendations.
3 What will the Act do?
The Act will implement several key recommendations of the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region (April 2001). The Inquiry Report identified significant barriers in the present law to effectively evaluate the National Cervical Screening Programme.
A key purpose of the Act is to facilitate the operation and evaluation of the NCSP. This is to ensure the safety and effectiveness of the NCSP for women.
The Act sets out objectives for the NCSP and provides for the appointment of evaluators to fully assess the effectiveness and safety of the Programme. The Act will allow evaluators to access all relevant health information of relevant women, to the extent necessary for each evaluation.
The legislation will improve the clinical care and safety of women enrolled on the NCSP as all cervical cytology results will be recorded on the NCSP-Register. These results form the woman's smear history, which is used by Laboratories, smear takers and specialists when making clinical management decisions on the woman. The Act will allow women to 'opt off' the Programme completely. 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 cancelled) will be entered on the NCSP-Register. Currently under Section 74A of the Health Act, women can opt off individual cervical results which means the NCSP cannot confirm that the woman's full screening history is stored on the NCSP-Register.
It is well recognised that high enrolment and participation rates help screening programmes to achieve their aims of improving the health of populations. There is a balance between enabling women to make an informed choice about being on the Programme and achieving high participation rates.
Under the legislation, depending on the nature of the evaluation activity, a woman who has cancelled her enrolment (or has never been enrolled) in the Programme but does later develop cervical cancer may still have her health information included in an evaluation. The Gisborne Cervical Screening Inquiry made it clear that it is these women's records that are potentially the most useful in evaluations (refer: recommendation 11.17).
Evaluators, who will be designated by the Director-General of Health, will be required to keep all personal information confidential and secure. The results of these evaluations will help identify areas of the Programme that may need to be improved.
There is a requirement under the legislation that both persons taking smears and the Programme, will be required to provide information to women about:
4 What were the additional changes made by the Minister of Health under the Supplementary Order Paper (SOP)?
The Minister's SOP made a number of proposals for amending the Bill, which should enable women to have further confidence in the National Cervical Screening Programme.
In summary these were:
5 How does the Act ensure women will be better informed about the Programme?
The importance of providing information to women is acknowledged in the Act, by making it an objective of the programme and the shared responsibility of the NCSP and screening programme providers. The Act also places a duty on the Director-General of Health to from time to time provide information, including that based on evaluation findings to women. Further the findings of the review committees will also be made available to the public.
Information provided to women
The Act specifically requires smear takers and the Programme to provide information to women entering the programme about:
The NCSP Manager will ensure information about the programme, and the effect of the new legislation, is made available to all women, including those women joining the Programme between now and the Act's commencement, before the Act comes into force.
6 The Act provides for screening programme evaluators - why is this important?
For the purposes of the Health (NCSP) Amendment Act, evaluation refers to the:
The term evaluation encompasses a wide range of activities - from routine (perhaps daily) monitoring and statistical evaluations 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 will provide 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.
The Act, therefore, enables the Director-General of Health to designate screening programme evaluators. Screening programme evaluators will need to have the technical competence to undertake an evaluation. Evaluators may be employees of the Ministry of Health or external to the Ministry.
Under the new legislation, evaluators will only be allowed to access the information necessary for the evaluation they are conducting. Depending on the nature of the evaluation, 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".
To recognise 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 the records they hold.
7 What requirements are there for public reporting of evaluation findings?
Under the Act it is both an objective of the NCSP and a duty on 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.
This change is welcomed because it adds to the transparency of evaluations - when the evaluations are more transparent women have more reason to have confidence in the Programme.
8 What assurances are there that evaluators will treat women's health information appropriately?
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.
9 How will the Act affect access to women's health information?
In line with the findings of the Gisborne Cervical Screening Inquiry, the Act places clear obligations on smear takers, colposcopists and the NCSP to advise women on the Programme that their records may be used for evaluation purposes. The Act allows evaluators to access the health information of relevant women without first seeking their consent. A relevant woman is one who:
The records of women who have opted-off the NCSP 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.
10 How will women be assured that their information is confidential and secure?
There are safeguards in the Act to protect women's health information. There are obligations on the NCSP to not disclose information held on the NCSP-Register, except in a number of limited situations. These include:
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 Bill 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, the Programme will inform her that information about her may be used for the purposes of evaluating the Programme. That information may include:
11 What does it mean if a woman doesn't want to be part of the NCSP?
A woman can advise the Programme that she does not wish to be enrolled in the Programme, or choose to cancel her enrolment in the Programme at any time. A woman can also choose to re-enrol on the Programme at any point. If she chooses to cancel her enrolment in the Programme, 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. These results inform the woman's smear history stored on the NCSP-Register which is used by Laboratories, smear takers and specialists when making clinical management decisions on behalf of the woman.
If a woman who has cancelled her enrolment (or has never been enrolled) in the Programme does later develop carcinoma in situ or invasive cervical cancer, it may be decided without her consent that her records are essential for inclusion in an evaluation.
12 What will happen 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.
13 Why is it important that standards can be mandated and enforced?
A fundamental finding of the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region was that the National Cervical Screening Programme must be effectively evaluated. Subsequent reports on the operation of the Programme have expressed concern that the lack of enforceable standards and the ability to evaluate performance against such standards poses a potential risk to the clinical safety of the Programme.
Currently the Programme has the ability to enforce standards only through direct contracts with providers such as Laboratories and District Health Boards, however, this does not apply to those smear takers who do not have a contractual relationship with the Programme. This means that the National Screening Unit, responsible for the operation of the Programme, lacks the ability to ensure compliance with the standards, or to audit the 5,300 smear-takers in the Programme.
The Health (National Cervical Screening Programme) Amendment Act includes the power to include standards in regulations that must be met by providers of screening, diagnostic and treatment services. This gives the National Screening Unit the flexibility to use a range of mechanisms to enforce relevant standards, ranging from the current contracting mechanism to the introduction of regulations, should contracting not lead to the necessary outcomes.
14 How will the changes in the Act be implemented?
The majority of the Act comes into force one year from the date of Royal Assent to the Bill. The National Screening Unit of the Ministry of Health, which has responsibility for the NCSP, has a process underway that will ensure the necessary changes are made by the date the Act comes into force and that women and health professionals alike are kept well informed about the developments and these changes as work progresses.
If these questions were not helpful please see the National Cervical Screening Programme (NCSP) Questions and Answers for further answers.