PROPOSAL

1. This paper proposes legislative amendments to the Health Act 1956 in order to improve the operation of the National Cervical Screening Programme (NCSP). A number of the proposals seek to allow access to personally identifiable data to facilitate monitoring and evaluation of the NCSP. The additional proposals seek to assist the operation of the NCSP by eliminating the difficulties with the current legislation.

EXECUTIVE SUMMARY

2. In October 1999, the then Minister of Health appointed a Committee of Inquiry to inquire into the apparent under reporting of cervical smear abnormalities in the Gisborne Region prior to March 1996. The Committee of Inquiry delivered its report on 10 April 2001. The Inquiry Report recommended that a number of legislative changes be made to ensure the effective operation of the NCSP.

3. In response to these recommendations, a public discussion document was released. This discussion document asked for feedback on the proposals to allow access to all NCSP-Register data, to all cervical slides, and to the clinical records of women who have developed invasive cervical cancer, in order to evaluate and monitor the NCSP. One hundred and one submissions were received and analysed.

4. In addition to the proposals contained in the discussion document, a number of other legislative changes are considered necessary to improve the operation of the NCSP. The additional proposals include:
   1. addition of a purpose statement;
   2. addition of definitions, to aid interpretation;
   3. extension of the information that is held on the NCSP-Register to include colposcopy and treatment data;
   4. clarification of the 'opt-off' provisions;
   5. safeguards and confidentiality provisions for information;
   6. retention of cervical cytology and histology slides.

   These additional proposals have not yet been the subject of public consultation, however there will be a chance for the public to make submissions on these proposals at the Select Committee stage.

5. A number of the proposals contained in this paper may be contentious. In particular, the proposal to access clinical records, as recommended by the Committee of Inquiry, was opposed by the majority of submitters. Due to the opposition, I have altered the proposals so that consent will be sought where practicable, before the clinical records are accessed. However, this compromise may still be contentious.

BACKGROUND

Committee of Inquiry

6. In October 1999, the then Minister of Health appointed a Committee of Inquiry to inquire into the apparent under reporting of cervical smear abnormalities in the Gisborne Region prior to March 1996. During the Committee of Inquiry, it became apparent that comprehensive evaluation of the NCSP was being obstructed by statutory barriers that prevented access to essential information.

7. In October 2000, Cabinet agreed that regulatory and legislative changes are required to facilitate access to identifiable personal information held on the NCSP-Register for researchers studying cancer and in order to audit the NCSP [CAB (00) M35/4 refers].

8. The "Report of the Ministerial Inquiry into the Under Reporting of Cervical Smear Abnormalities in the Gisborne Region" was released on 10 April 2001. This report made a number of recommendations for legislative change in order to facilitate evaluation, monitoring, and audit of the NCSP.

Discussion Document

9. Following Cabinet approval on 14 May 2001 [CAB (01) 15/6 refers] the Ministry released a discussion document asking for public comment on proposed changes to the Health Act to implement the recommendations of the Inquiry. Submissions were received between 6 June and 16 July 2001. An analysis of the submissions is attached at Appendix III.

10. Pacific fono were held in seven regions to provide Pacific women and their families with an opportunity to discuss the proposals contained in the discussion document.

11. In addition to the proposal contained in the public discussion document, a number of other legislative proposals are discussed in this paper. These additional proposals have not been consulted on, but have been signalled by the Inquiry report, and are considered necessary to have a NCSP that operates as effectively as possible.

COMMENT

Definitions
NCSP-Register

12. The NCSP-Register holds enrolled women's demographic details, their smear results, their histology results, and details of smear-takers, health centres, and laboratories. As a clinical management tool for the programme it is used to produce a number of reports and letters. The NCSP-Register is also used to monitor aspects of the NCSP.

Monitoring, evaluation, and audit

13. The terms "Monitoring", "Evaluation", "Audit" are used throughout this paper. For ease of understanding these terms are defined as
    1. Monitoring: The continuous supervision of an activity for the purposes of checking whether plans and procedures are being followed."

    2. "Evaluation" is a comparative assessment of the value of an intervention, in relation to criteria and using systematically collected and analysed data, in order to decide how to act. Evaluation in this case includes Clinical Audit""

    3. Audit: falls within the meanings of "monitoring" and "evaluation" and is an investigation into whether an activity meets explicit standards, as defined by an auditing document, for the purpose of checking and improving the activity audited".

14. If the changes proposed in this paper are agreed to, then the Health Act 1956 should also be amended to include appropriate definitions of audit, monitoring and evaluation, the programme, slides, and clinical records. The Ministry of Health will work with Parliamentary Counsel Office to develop appropriate legal definitions.

PROPOSALS FOR LEGISLATIVE CHANGE

Purpose statement

15. I propose that a purpose statement be added that extends the scope of the section beyond the NCSP-Register to include the ambit of the entire NCSP and its aims. The inclusion of a purpose statement will make it clearer that the intention of section 74A is to provide for an organised screening programme; to ensure the safety and effectiveness of that Programme through audit, monitoring and evaluation; a reduction in the incidence and mortality of cervical cancer through early detection; and to facilitate research into cancer via the regulation making process.

Extend NCSP-Register to colposcopy and treatment data

16. I propose that the NCSP-Register is extended to include the assessment and treatment history, and whether further treatment is recommended/required. The reasoning behind this is that while the programme is set up to reduce the incidence and mortality rates from cervical cancer through the early detection of precancerous squamous cell changes, without timely and adequate treatment there is little point in detecting the precancerous cells. I propose that the legislation requires the colposcopy and treatment data to be supplied.

Clarification of opt-off provisions

17. Currently there is a lack of clear definition around what it means to be enrolled in the NCSP. Enrolment in the NCSP-Register, and thus the NCSP, occurs when a woman has a cervical smear taken. Section 74A of the Health Act 1956, as currently drafted, requires that every time a woman has a smear taken from her cervix, or a histology biopsy taken, she must be advised that her results will be entered onto the NCSP-Register unless she objects. Prior to a smear or biopsy being taken it is expected that the smear-taker will explain the clinical procedure, the importance of having regular smear tests, the purpose of the NCSP and NCSP-Register and determine whether a woman objects to having her results forwarded to the NCSP-Register.

18. A woman can request that a particular test result not be sent to the NCSP-Register at the time of the smear test or the taking of histology. If a woman wishes to "opt-off" a particular result from the NCSP-Register, her smear taker indicates this to the laboratory. The NCSP does not receive any notification of the decision to "opt off" that particular result from the NCSP-Register. Because "opting off" one result, does not constitute an exit from the NCSP this can lead to the appearance of a complete history for the woman on the register, when in fact one or more results may be missing. Incomplete screening histories impede the effective monitoring, audit, and evaluation of the NCSP.

19. In addition to this there are also difficulties for laboratories and smear-takers that may be reliant on the smear-history from the NCSP-Register, particularly for new patients. The Committee of Inquiry recommended "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". It will only be useful to implement this recommendation if the results stored on the register are accurate and complete. Otherwise, laboratories will be relying on a source of information that is incomplete. This creates a risk for the laboratories reading the slides, and for the woman involved.

20. I propose that the Health Act be amended so that women cannot choose to opt particular smear results off the Register. Instead the NCSP becomes an opt-off programme. Women would still be able to decide either to opt-off the NCSP or to remain enrolled on the NCSP. This change will mean that the NCSP, NCSP providers and women can be more confident that a woman's screening history on the NCSP-Register is complete. If a woman chooses to opt-off the programme consent will be sought to have her information sent to NCSP-Register in a non- identifiable form. If this consent is obtained the medical professionals involved in the collection of this information will be required to forward it to the NCSP-Register.

21. This proposal has not been consulted on at this stage. However, there will be a chance for the public to make submissions on these proposals at the Select Committee stage. This proposal is not considered to be controversial.

Consent and Authorisation to access relevant information

22. Much of the information that needs to be accessed for monitoring and evaluation purposes is subject to requirements of consent or authorisation from the woman to whom it relates. Requirements to gain informed consent and/or authorisation were identified by the Committee of Inquiry as a potentially significant barrier to effective and efficient monitoring, evaluation, and audit of the NCSP.

23. The Committee of Inquiry¹ found that

    "the need to obtain informed consent before gaining access to protected information poses practical and technical problems. Women are not always easily traceable. Secondly for the conclusion of an evaluation to be statistically meaningful and therefore informative to medical experts the evaluation exercise must cover a sufficiently large group of women. If only a small number give their consent the exercise will be pointless. The Committee considers that faced with these problems the best choice is to permit medical experts who have been engaged for the purpose of evaluating the Programme to have access to the information without the need to obtain women's consent. It is difficult to see why women might object to an independent evaluation team seeing information to which those medical persons who are involved in their treatment have unrestricted access. If evaluation is seen as an integral part of a woman's treatment under the Programme there is no difference." (Para 6.98)

24. The concerns of the Committee of Inquiry about participation in audits are supported by recent experience. An evaluation of the management of women with abnormal screening histories has recently been undertaken by experts from Otago University on behalf of the Ministry of Health. Provisional results indicate that of the 415 women selected as the sample for this study (using 1999 information) complete data were collected for 231 individuals, a response rate of 55.7 percent. Of the remaining 184, 80 women (19.2 percent) declined to participate (and 101 women (24.3 percent) could not be located. There were much lower response rates among Mäori and Pacific women (27.9% and 31.3 % respectively). Mäori women were both more likely to refuse to participate (26.2%) and more difficult to locate (46.8% not located either for consent or interview) compared with non- Mäori, non-Pacific women (11.8% and 24.5 respectively). Pacific women were also difficult to locate (41.9% not contacted their for consent or interview)². The woman invited to participate in this evaluation were women who had smears taken in 1999. The fact that less than two years after their smears were taken almost 25% percent of the women could not be located is significant.

25. It is due to these difficulties in locating women and seeking authorisation that legislation requiring access to relevant data is proposed as discussed in paragraphs 26-47.

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Footnotes:

1

AP Duffy, DK Barrett, MA Duggan, Report of the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region, April 2001.

2

Dr Diana Sarfati et al "the Management of Women with Abnormal Cervical Smears"