Media Statement

10 April 2001

Response to the Recommendations of the Gisborne Cervical Screening Inquiry Report

The Director-General of Health, Dr Karen Poutasi and the Ministry are committed to learning the lessons from the Gisborne Inquiry and building on the progress made to date in strengthening quality standards and monitoring mechanisms across the health sector.

Accordingly she has advised the Minister to appoint an overseas expert to report on progress in effectively implementing the recommendations of the Cervical Screening Inquiry Report.  Of the 46 recommendations in the Report, 27 are either underway or completed. 

1. Completion of the National Evaluation

The Ministry of Health is currently carrying out a three-part evaluation of the National Cervical Screening Programme (NCSP).  Phase one has been completed; phase two covering the evaluation of the treatment of women with abnormal smears is due for completion by Otago University by 30 June 2001. 

Phase three, which includes an audit of cases of cervical cancer, is now being managed by the National Screening Unit (NSU).  This phase can best be compared to a complex research project and therefore requires a carefully prescribed and adequate timeframe.  A protocol for this phase supplied by Dr Brian Cox of the University of Otago set out a timeframe of 25 months for its completion. The National Screening Unit has developed a plan with an 18 month timeframe for its completion, in August 2002. 

The Ministry believes the safety of the Programme is demonstrated by several key indicators.  For instance the number of women developing and dying from invasive cervical cancer has declined since the 1990s, and much of this decline can be attributed to the NCSP.  Age-standardised mortality rates for cervical cancer have declined from 4.9 per 100,000 in 1988 to 2.9 per 100,000 in 1997.   Incidence has also declined from 13 per 100,000 in 1988 to 9.2 per 100,000 in 1998. 

Prior to the completion of the three-part (retrospective) evaluation, women can have confidence in the programme due to the following actions undertaken by the NSU:

•  Implementation of the NCSP Interim Operational Policy and Quality Standards in October 2000;
  
  

• Ongoing quarterly monitoring of the Programme;
  
  

• Improved data management and management reporting processes;
  
  

• Introduction of contractually binding obligations on providers.

2. The completion of the Evaluation and the possible re-enrolment of all women in the NCSP

Should the national evaluation throw doubt on the accuracy of the current standard for reporting high-grade abnormalities, women will be invited to re-enrol in the Programme and receive two smear tests 12 months apart.

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3. A comprehensive evaluation of the NCSP should be commenced within eighteen month

A comprehensive evaluation of all aspects of the Programme, based upon Dr Cox and Dr Richardson’s 1997 Draft Evaluation Plan, will be commenced within the next 18 months.  Five of the 13 components of the Evaluation Plan have already been completed, and two further components are underway as part of the audit discussed under 1. 

4. The NCSP Interim Operational Policy and Quality Standards and the Evaluation and Monitoring Plan for the National Cervical Screening Programme should be implemented fully within the next twelve months.

Both documents will be implemented in full within the next twelve months.  Policy and Quality Standards have now been incorporated within Contracts for Services between the Ministry and District Health Boards and Community Laboratories. 

5. There should be a full legal assessment of the ‘Policy and Quality Standards and the ‘Evaluation and Monitoring Plan for the National Cervical Screening Programme’.

6. The NCSP should be legally assessed for authority to discharge its responsibilities.

These legal assessments will be carried out.

7. The NCSP should issue annual statistical reports. These reports to focus on quality aspects of the NCSP, including laboratory quality.

The NSU will prepare statistical reports on an annual basis.  The 1996-1998 Statistical Report will be completed by 30 June 2001. This is the first report to be completed by the NSU and the first report since 1995.  The 1999-2000 Statistical Report will be completed by December 2001.

Quarterly Monitoring Reports are also produced to provide detailed statistical analyses on a more regular basis.  These include laboratory performance and other quality aspects of the NCSP. 

8. The Cancer Register and NCSP- Register should generate regular statistical information. This information to include regional laboratory reporting rates as well as trends and incidence of disease.

The Cancer Register currently produces annual statistics of the incidence of invasive cancer of the cervix and can produce statistics comparing incidence by region of residence.  This information can be produced more regularly than once a year but because the number of cases is small in statistical terms (about 230 a year) production of more frequent statistics may not be meaningful for comparison between regions.

The NCSP-Register provides raw data to the Independent Monitoring Group to enable quarterly monitoring to occur.  The NCSP-Register also produces monthly statistical reports covering enrolment and participation in the Programme.

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9. All cytology laboratories should comply with a standard related to minimum volumes per annum.

The NSU has implemented this recommendation within the NCSP Interim Operational Policy and Quality Standards.  These Standards were incorporated within Community Laboratory Contracts as of November 2000 and will be incorporated within DHB Agreements from 1 July 2001.  All laboratories will be required to comply with the minimum volume standards from the 1 July 2001. 

10. There needs to be a balanced approach to all aspects of the NCSP.

This relates to historic criticisms of the NCSP in the report.  The NSU has adopted a balanced approach to all aspects of the programme. 

11. Dr Julia Peter’s 'culture' needs to be preserved.

The newly established NSU within the Ministry of Health will continue to develop the culture and approach that was initiated by the Health Funding Authority (HFA).  The NSU is committed to ensuring WHO Management Guidelines for Successful Screening Programmes are adhered to. 

12. The NCSP must be managed within the Ministry as a separate unit, lead by a manager with authority to contract directly with providers.

The NSU has been established within the Ministry as a separate unit with its own operating and service budgets.  The NSU is working towards contracting directly with providers of the Programme.  The NSU will contract directly with District Health Boards as of 1 July 2001 for the provision of services.  This direct contractual relationship will be extended to Community Laboratories before the end of the year. 

13. The NCSP manager should be second or third tier.  The manager to hold medical specialist qualifications in public health or epidemiology.

Dr Julia Peters, a specialist in public health medicine, is the clinical leader for the NCSP.  Given the complexity of managing 33 staff and a significant number of contracts, this leadership role is shared with a newly appointed (third tier) Group Manager, Karen Mitchell.  This arrangement provides the Unit with a strong combination of both clinical and management skills at its highest level.  Ongoing recruitment of staff in policy, quality audit and monitoring, provider relationships, IT, contracts and finance and Maori health will further strengthen the NSU. 

14. Amend section 74A of the Health Act 1956 to enable audit and evaluation of the NCSP.

15. Reconsider the Kaitiaki Regulations to ensure appropriate access to aggregated Maori data for audit, monitoring and evaluation.

16. Clarify the legal right to access information on the Cancer Register.

17. Amending the Health Act 1956 to enable improved access to files recording the treatment of cervical cancer.

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The Ministry believes that legislative changes made to ensure that effective programme monitoring and evaluation occurs must also include appropriate legal protections for the screening workforce.  In addition, there are a range of other issues relating to Section 74A which need to be considered when it is to be amended.  For example, there may be a need for provisions which enable colposcopy data to be collected from public and private clinics and to ensure smear-takers inform women of their rights to participate in the NCSP.

In relation to access to Cancer Registry data, the Inquiry questioned NZHIS policy on access to identifiable data, which was to require ethics committee approval.  The policy has since been changed to enable release of identifiable data from the Cancer Registry without ethics committee approval by applying the Official Information Act.  However, the Committee’s recommendation is for legislative change to put the issue beyond doubt.    Legislative change is also required for electronic linkages between the NCSP-Register and the Cancer Registry  (23), retention of slides (30), and on-line electronic access between the NCSR and cytology laboratories (31). 

Cabinet has already agreed to regulatory and legislative changes to facilitate access to personal information held on the NCSR, and has noted that amendments to section 74A of the Health Act are likely to be required.  A discussion paper would be prepared for public consultation on the implementation of the Government’s decision, and submitted to Cabinet for consideration before its release.

The report contains some proposals which need to be added to the discussion document, particularly the change to the scope of the Kaitiaki Regulations to allow access to information to audit and legislation, as well as setting out the committee’s views on the relationship between informed consent and audit.  The Ministry intends to issue a discussion document to reflect the committee’s views.  This will focus on inviting women, including Maori women, and health professionals to respond by indicating what they require to have confidence in the NCSP.

18. Change the guidelines under which ethics committees operate.

19. Review the operation of ethics committees, including the impact of their decisions on evaluation of services and medical research generally.

20. Provide guidance to ethics committees regarding application of the Privacy Act and Privacy Health Information Code.  A lawyer should sit on each ethics committee.

21. Provide guidance to ethics committees about the ways to balance harms and benefits of observational studies.

22. Establish a national ethics committee for multi-centre studies.

23. Establish an appeal procedure to allow for re-examination of ethics committee decisions.

Section 16 of the NZ Public Health and Disability Act 2000 requires the Minister of Health to establish a national ethics committee to advise on ethical issues of national significance in respect of any health and disability matters (including research and health services).  This committee would be well placed to carry out the review of the operation of the ethics committees and advise on the other issues included in the recommendations.  It is likely to take up to three months to establish the committee, allowing for the process of making appointments to this statutory committee.

24. The NCSP should have its own consumer complaints system.

The NSU will develop a mechanism to address individual complaints. This will build on work around the Health Professionals Competency Assurance Bill, which will address the issue of complaints relating to health professionals.

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25. Electronically link the Cancer Register and the NCSP-Register.

Information from the Cancer Register for 1990-1997 has been released to the Screening Register in electronic form and this process will continue in the future.  The National Cervical Screening Register cannot supply personally identifiable information to the Cancer Register however.  To affect an electronic link will require legislative change as noted above.

26. There should be performance standards for the NCSR and the Cancer Register.

The Cancer Register is moving to improve the timeliness of information about the incidence of cervical cancer.  Cervical cancer cases are treated as priority cases for processing, with information being available to 2000.  This level of timeliness ranks New Zealand as a leader internationally.

Performance standards for the NSCP-Register have been incorporated into the NCSP Regional Office Service Specification that forms a schedule to the DHB Agreement and the NCSP Register Operating Protocol, version 2.0 of which is to be released in July 2001.

27. Standards for the NCSP should be reviewed every two years. 

The NSU will ensure that a full review is completed every two years and an updated publication of Standards is produced.  The first full review of Standards will be completed by October 2002.

28. The Government must ensure sufficient cytotechnologists and cytopathologists and sufficient training sites.

The NSU has begun a project that will provide it with a workforce development plan for the NCSP by December 2001.  This work is being undertaken by a project team with experience in this area.  The project team will immediately focus on the issues of workforce planning and training for cytotechnologists and cytopathologists.

29. Amend the Medical Laboratory Technologists Regulations 1989 to permit only registered medical practitioners with specialist qualifications in pathology and appropriate training in cytopathology or appropriately trained cytoscreeners to read smears.

The Medical Laboratory Technologists Regulations 1989 can be amended to ensure medical laboratory technologists who intend to be cytoscreeners are appropriately trained to read smears.

Medical practitioners registered under the Medical Practitioners Act 1995 (who would be expected to have vocational registration in pathology), and who read smears, generally do not also register as medical laboratory technologists.  Amending the Medical Laboratory Technologists Regulations 1989 will not serve to regulate smear reading by medical practitioners who choose not to also be registered as medical laboratory technologists.  However, a requirement for training for medical practitioners to appropriately read smears could be achieved by an Order in Council under section 21 of the Medical Practitioners Act 1995.

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30. Impose legal obligations, related to storage of slides, on laboratories that take over slides from laboratories that close.

Retaining records, cytology smears, and histology specimens of patients is something that is closely linked with the Health (Retention of Health Information) Regulations 1996.  Those regulations require a minimum retention period for health records of 10 years, but they do not apply to cytology smears or to histology specimens.  

In order to put in place the obligations in this recommendation an amendment would be made to the Health Act 1956 (along with amendments to section 74A) to ensure the regulations can also cover cytology smears and histology specimens.  This would be followed by an amendment to the regulations to put the new obligations in place, and the Ministry will work on this new legislative change.

In relation to the period of retention, the Ministry considers that, given the slow development of cervical cancer, 5 years may be insufficient.  The current NCSP Interim Policy and Quality Guidelines recommends that cytology slides be retained for 14 years and histology slides for a minimum of 20 years.

31. Ensure electronic link between the NCSP-Register and cytology laboratories.

The NSU will incorporate this within its forthcoming information systems strategy review project.  Legislative change will also be required.

32. Develop standards for accuracy of laboratory coding.

Standards currently exist. Processes are being developed to ensure accuracy of laboratory coding and an appropriate quality assurance process for this aspect of the NCSR.

33. The NCSP should develop a population register.

The current NCSR is a 'utilisation' register, meaning it is based on people who choose to use the NCSP as opposed to being based on population criteria such as everybody living in an identified area.  There are a number of population databases in New Zealand but further work will be required to assess the feasibility of using them as part of the two cancer screening programmes. 

34. Legal mechanisms should be in place to allow ACC, the Medical Council, and the Health and Disability Commissioner to share relevant information with the NCSP.

A new Bill, the Health Professionals Competency Assurance Bill, is proposed, together with amendments to the Health and Disability Commissioners Act and ACC legislation that will ensure sharing of information about complaints against health practitioners between the agencies. The Medical Council will be empowered to suspend a medical practitioner if there are reasonable grounds to believe that he/she is practising below standard and the public is at risk of harm  (as will other registering authorities if the complaint concerns another profession).  This provision would cover the situation of a complaint about a practitioner involved in the NCSP.

Similarly, it is intended that the new Bill will require health professionals to report to the appropriate registering authority any colleague whom they believe to be practising below standard. This provision would apply to the health professionals involved in the NCSP.

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35. The Medical Tribunal should be required to provide relevant information to the NCSP if there is a threat to public health.

If it becomes apparent from the investigation of a complaint, or during disciplinary proceedings that there may be a health systems problem which puts other patients at risk, a provision will be developed to inform the appropriate authority of the risk. This may be the Director-General or the Minister of Health.

36. The ACC and Medical Council should exchange relevant information regarding claims for medical misadventure and disciplinary actions against medical practitioners. 

The ACC already informs the Medical Council of cases of medical error.  It is intended that the new Bill and amendments to the Health and Disability Commissioners Act and the ACC legislation will ensure that there is sharing of information between the Agencies to identify if a pattern of medical misadventure is emerging.

37. The NCSP should establish a collaborative relationship with the Royal College of Pathologists of Australasia.

The NSU has striven to develop a collaborative relationship with the College and to ensure that College representation is sought where expert pathology advice is required.  An example of this was the introduction of the NCSP Interim Operational Quality and Policy Standards.  The NSU is keen to expand its relationship with the College in any ways that would benefit the Programme.

38. The NCSP should provide women with information to make informed decisions about screening before the completion of the three-part evaluation.

The NSU has a contract in place with Women’s Health Action to develop new, more detailed information for women regarding the NCSP and the benefits and risks of screening.  A user-friendly website and an 0800 number have been set up to give women better access to information. 

It is also important to inform women that significant symptoms and signs of invasive cancer should not be ignored despite a previous normal smear.  The NSU is currently looking at additional communications strategies to increase understanding of these key messages.

39. Remind medical practitioners that cervical smears are not a diagnostic tool.

The NSU intends to write to all smear-takers and medical practitioners to emphasise this message.  The Ministry will also work with the relevant health professional colleges to reinforce the message that a cervical smear is primarily a screening test, not a diagnostic tool.

40. Cervical screening should be done by appropriately trained personnel – including pathologists who want to function as primary screeners.

41. Cytopathologists must participate in continuing education in cytopathology.

42. All pathologists undertaking cytology should be appropriately trained.  This ought to be mandatory.

These issues will be addressed through the NSU workforce development project and the Health Professionals Competency Assurance Bill.

The Medical Practitioners Act 1995 already provides for the Medical Council to assess the ongoing competence of registered practitioners.  It is intended that the new legislation will make it compulsory for a practitioner to take part in a training programme if required to do so by the Council following a competency review.

43. Pathologists ought to be more open minded and critical of laboratory performance.

The Ministry intends to write to pathologists on this issue.  The quarterly independent monitoring group reports will assist pathologists in assessing their standard as these reports will provide comparative data on laboratory performance.

44. The Medical Council should ensure that systems are in place to support the early reporting of errant medical practitioners by their colleagues.

This issue will be addressed through the Health Professionals Competency Assurance Bill (see 34).

45. The NCSP should have a system for identifying deficiencies.  Consumer surveys would be useful.

The NSU will explore additional systems which will enable it to identify any deficiencies in the NCSP.  Surveys of users of the Programme could be one component of this and are currently a feature of the national breast screening programme, audit and evaluation processes.

46. There should be a system for monitoring the implementation of the Committee’s recommendations.

The Director-General will brief the Minister each month, with this frequency to be reviewed after 6 months.  The Minister has accepted the Director-General's recommendation to appoint an independent international expert, Dr Euphemia McGoogan, to independently advise the Minister about progress. 

Dr McGoogan is an expert cervical cytopathologist from Edinburgh.  Currently she is a senior lecturer in pathology at the University of Edinburgh and the Patient Services Director of Pathology at Lothian University Hospital NHS Trust.  She is a member of a significant number of national and international committees including the International Academy of Cytology Executive Council and the European Federation of Cytology Societies Education and Quality Assurance Committee (QUATE).  She appeared as an expert witness at the Gisborne Cervical Screening Inquiry.