Design Gisborne Cervical Screening Inquiry
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Questions & Answers for Release of Second OAG Report

1. What is the Office of the Controller and Auditor General?
2. Why did the OAG review the NCSP?
3. What was the scope of the OAG report?
4. What are the key findings of the OAG’s second report?
5. Why have only some Standards been reviewed?
6. Why have the provider audits not commenced?
7. What is happening with workforce development?
8. What is happening with proficiency testing?
9. What is happening with liquid based cytology and new technologies?
10. What is happening is the Audit of Invasive Cervical cancer?
11. What is the National Cervical Screening Programme (NCSP)?
12. What is the National Screening Unit (NSU)?
13. What was the Gisborne Cervical Screening Inquiry?
14. What can a cervical screening programme do?
15. How effective is the NCSP?
16. How have cervical cancer rates changed since the NCSP began?

 

1. What is the Office of the Controller and Auditor General?
The Office of the Controller and Auditor General (OAG) is a statutory office created by Parliament under the Public Audit Act 2001. 

As part of its accountability requirements, Parliament seeks independent assurance that public sector organisations are operating, and accounting for their performance, in accordance with Parliament’s intentions. The Auditor-General is an officer of Parliament. In that capacity, the Auditor General is independent of the Prime Minister and other Ministers and answerable to Parliament. 

2. Why did the OAG review the NCSP?
In October 2001 the OAG wrote to the Director General of Health advising her that the OAG intended to carry out a review to determine what action had been undertaken to implement the recommendations of the Inquiry into the apparent under reporting of abnormal smears in the Gisborne region.

The OAG released their first report in February 2002 and concluded that good progress had been made in a number of areas, but effective monitoring, audit and evaluation of the NCSP still required action. The OAG advised the Minister of Health that they intended to keep the progress of implementing the Inquiry recommendations under review. The OAG undertook this by maintaining contact with Dr McGoogan and reviewing the Ministry’s monthly and quarterly reports to the Minister.

Dr McGoogan produced her second and final report on the progress of the implementation of the recommendations in June 2003. This report followed Dr McGoogan’s last visit to New Zealand in January 2003. Following the release of Dr McGoogan’s report, the Minister of Health contacted the OAG requesting a follow up review of the progress of the implementation of the 46 recommendations, in particular since Dr McGoogan’s visit in January

The Auditor-General’s response to such requests is discretionary. The OAG had, however, intended to do a follow up review six months after Dr McGoogan’s second report had been issued. It was decided to bring the timing of this review forward because of the high profile of the NCSP and its importance from a public health perspective.

The OAG commenced its review in July 2003. This involved meeting with National Screening Unit (NSU) staff and other Ministry of Health officials, and a number of external stakeholders. The NSU also supplied extensive documentation for the OAG to consider as part of its review.

3. What was the scope of the OAG report?
In its second report, the OAG sought to establish:

  • What progress the Ministry had made since Dr Euphemia McGoogan’s final review (in January 2003) to implement the 46 recommendations of the Committee of Inquiry.
  • The issues and reasons why the Ministry is not progressing as quickly as recommended with the implementation of some recommendations; and
  • How and when the Ministry intends to address other issues raised in Dr McGoogan’s report.

4. What are the key findings of the OAG’s second report?
The OAG’s second report concludes that good progress is being made in a number of areas, however the OAG did find that more work still needs to be done to ensure that appropriate assurance processes exist around the quality aspect of the programme (ref below).

The OAG’s report provides a summary of progress made in implementing the recommendations of the Inquiry, as follows:

  • 31 of the 46 recommendations have either been implemented or will be completed by June 2004.
  • A decision was made not to implement two recommendations relating to the leadership of the NSU and the reconsideration of the Kaitiaki Regulations.
  • A decision still has to be made the recommendation to offer women two smear tests 12 months apart dependent upon the cancer audit outcome.
  • Work has begun on eight recommendations but they are unlikely to be completed by June 2004, including the audit of invasive cervical cancer.
  • Work has begun on a further four recommendations relating to ethics committees but it is unclear whether they will be implemented.

It is noted by the OAG that “the most significant progress has been made on the recommendations requiring legislative changes, progressing the recommendations on which work was well advanced at the time of the Committee of Inquiry, and the recommendations that were relatively straightforward to address.”

Both Dr McGoogan and the OAG identify that there is still much to be done on recommendations related to the Audit of Invasive Cervical Cancer, screening workforce development and information technology developments. In relation to the Audit of Invasive Cervical Cancer, however, the OAG finds that it is progressing as fast as could be expected given its magnitude.

The OAG has noted that more work needs to be done to ensure appropriate quality assurance processes are in place. The OAG refers particularly to the need to complete the review of all NCSP policy and quality standards and carry out audits of provider compliance with those standards. 

The OAG has identified areas that it believes are key to “completing the puzzle” referred to in Dr McGoogan’s final report and is concerned that recommendations related to these areas have been slow to progress. These areas include:

  • Ensuring that the NSU’s is more willing to listen and be more open and collaborative with stakeholders and draw more on the knowledge and resources of the professional colleges in particular.
  • Completion of the Cancer Audit.
  • Providing electronic access to information on the NCSP-Register for service providers with the aim of improving data quality.
  • Development of a population register utilising the National Health Index.
  • Implementation of quality standards for smear-takers and private colposcopists.
  • Ensuring that all policy and quality standards introduced in 2001 are reviewed and updated, and provider compliance is audited.
  • Ensuring that is a sufficiently trained and skilled workforce for cervical screening, and that the proficiency of staff involved is measured at an individual level.
  • Maintaining ongoing independent monitoring of the programme.
  • Completion of the work of the National Ethics Committee.
  • Systems are in place to identify and assess new technologies such as Liquid Based Cytology.
  • Establishment of a specific Quality Manager role within the NSU.

In its detailed commentary, the OAG acknowledges that work is progressing on all of the areas identified as key to completing the puzzle.

5. Why have only some Standards been reviewed?
The OAG states that the NSU needs to regularly review all 51 NCSP Interim Operational Policy and Quality Standards (IOPQS). The NSU has already identified this as a priority and work has already been undertaken in this area and further work is planned for 2003/04 and 2004/05.

Experience has shown that once policy and quality standards have been developed they need to be adopted and implemented by providers. This can take at least 6 – 12 months and requires sector cooperation and support. Following the implementation period, the review of standards would usually be carried out every 2 - 3 years. This timeframe allows sufficient “bedding in” period by the sector of these standards. Given that the IOPQS only really became effective for contracted providers in July 2001, the NSU believes that realistic progress has been made regarding the ongoing review of the IOPQS.

6. Why have the provider audits not commenced?
The OAG acknowledges that implementing quality standards is an important first step, however they note that an equally critical step is the checking that providers meet the standards. The OAG states that the NSU needs to audit providers to establish that they are complying with standards and that not doing so reduces the value of the standards substantially.

The NSU had already identified provider audits as a priority and work has been ongoing in this area in anticipation of the contractual changes as outlined below. This work has included the development of a NCSP Audit Framework, which has incorporated consultation feedback from the sector - a process which took 15 months.

It should be noted that until recently, the NSU has not been in a position to audit laboratories due to the laboratories being contracted under the (general) Community Laboratory Agreement which made no provision for the separate auditing of NCSP services. The audit provision in the Community Laboratory Agreements related to financial audits only. These agreements were devolved under an Order in Council to DHB’s in 2001. Currently, nine laboratories have signed direct NCSP Laboratory Agreements that allow NCSP specific laboratory audits, and negotiations are underway with the remaining three laboratories.

Despite the contractual limitations faced by the NSU, the OAG state that the NSU should have investigated other interim arrangements with either IANZ or other accreditation agencies. In September 2003 an agreement was reached between IANZ and the NSU to work collaboratively to ensure that the NCSP provider compliance audits and IANZ accreditation of laboratories is closely aligned.

With the recent introduction of new colposcopy standards the NSU is now in a position to audit the 21 DHB colposcopy service providers.

The NSU is not in a position to audit the 5,300 smear takers as there is no contractual relationship between the smear takers and the NCSP. The NSU and the College of General Practitioners are however, working together to review smear taker standards and how they might be implemented. The College’s practice review tool entitled “Information Practice Review Activity to Aid in the Provision of Quality Cervical Screening in General Practice” is based on the NCSP standards. These standards are seen as a benchmark for best practice by the College and have also been used by the Health and Disability Commissioner. The NSU, along with the College of General Practitioners and the College of Practice Nurses (both of which are represented on the NCSP Advisory Group) will need to work together to consider the implementation of standards in this area. Also, a number of workforce initiatives are underway to develop and support the screening workforce, including the training of practice nurses to become smear takers and the support required to supervise these trainees.

7. What is happening with workforce development?
The OAG noted that there was a lack of suitable training courses for health professionals working in the programme. The NSU highlighted to the OAG however, that specialised training providers best meet the training requirements of registered health professionals. Training is one component of continuing medical education or professional development and includes a variety of activities including conferences, seminars, and meetings for each professional group to improve knowledge and competencies. The NSU has developed a Workforce Development Strategy setting out a longer-term approach to cultivate and support a screening workforce. The main aim of this strategy is to provide a strategic framework, as well as a plan of action to guide the ongoing development of a competent and capable screening workforce, which the NSU regards as being the key to maximising the benefits of screening programmes and ensuring their sustainability.

8. What is happening with proficiency testing?
The OAG agreed with the NSU that proficiency testing is a critical part of the overall quality assurance system. The NSU, as with provider compliance audits, was not in a position to have implemented proficiency testing for laboratories in advance of the NCSP Laboratory Agreement. As proficiency testing also requires the support of; the Royal College of Pathologists of Australasia (RCPA), the laboratories, and the laboratory workforce, the NSU felt that it was important to establish a good foundation for these initiatives through the development of an overall workforce development strategy. The OAG notes that there were a range of views of those members of the laboratory workforce interviewed regarding the introduction of individual proficiency testing. 

9. What is happening with liquid based cytology and new technologies?
The NSU notes the OAG’s comment regarding the introduction of Liquid Based Cytology (LBC) into New Zealand, which predates the establishment of the NSU. The NSU shares this concern, particularly given the work of the HFA who commissioned a review by New Zealand Health Technology Assessment (NZHTA) which subsequently concluded that the conventional smear should be the standard for the NCSP. Despite health professionals being advised of this recommendation at the time, active marketing by Biocare (the New Zealand distributor of the ThinPrep test) has seen many primary care providers choosing to provide this option to their patients, and laboratories are providing a service for this new technology. Ordinarily the NSU would not develop standards for practice that it has not recommended as part of the programme. The NSU has commenced further work in the area.

The OAG comments that even where the NCSP does incorporate the review of new technologies as part of ongoing quality initiatives, the introduction of these technologies may occur regardless of the NSU’s work. It must be noted that where these services are not publicly funded, there is less ability to regulate standards and practice. The OAG acknowledges that this problem is not unique to cervical screening. Throughout the health system it is difficult to regulate the introduction of new technologies where public demand and a willingness to pay for primary care services overrides the advice of the Ministry

10. What is happening is the Audit of Invasive Cervical cancer?
The OAG acknowledges that the Cancer Audit has taken longer than promised but in their view it would have been difficult to complete any earlier. They comment that the Ministry of Health under-estimated the size of the task, as did clearly the Committee of Inquiry when they recommended it be completed within 6 months.

The OAG provided comment on the intention of the NSU to review new cases of invasive cervical cancer as they arise and have included some of the results from the NSU’s preliminary review of 23 cases. It should be noted that the NSU’s preliminary view has been limited to what can be ascertained from the screening histories of these women held on the NCSP-Register. Until the Health (National Cervical Screening Programme) Amendment Bill is enacted, the NSU is unable to seek further information without the explicit consent of the women involved.

11. What is the National Cervical Screening Programme (NCSP)?
The National Cervical Screening Programme (NCSP) was the first organised cancer screening programme in New Zealand. It was established in 1990, by the then Department of Health, to reduce the incidence and mortality rate of cervical cancer through a nation-wide ongoing organised screening programme that would detect the majority of cases in the early pre-cancerous curable stage. 

The NCSP is managed by the National Screening Unit of the Ministry of Health and encompasses health promotion, smear taking, laboratory analysis of cervical smears and cervical biopsies, and the management of women with abnormal smear results. The NCSP is delivered to New Zealand women by a range of providers including health promoters, general practitioners, gynaecologists, nurse smear takers, family planning centres, midwives and laboratories. Regional co-ordination of the NCSP, which includes the operation of the National Cervical Screening Programme-Register (NCSP-Register), is managed through eight NCSP Regional Services linked to a central database. 

The focus of the NCSP is on women aged 20-69 years who have never had a smear or whose previous smear was more than five years ago. Women aged over 40 years and Maori and Pacific women are priority groups in the NCSP.

12. What is the National Screening Unit (NSU)?
The National Screening Unit (NSU) is a separate business unit of the Ministry of Health and is responsible for the national operational and strategic management of the two current cancer screening programmes, the National Cervical Screening Programme (NCSP) and BreastScreen Aotearoa (BSA). These functions include: providing national leadership, strategic direction, advice to Government, the development and management of nationally consistent policy and quality standards for the national programmes, prioritising the improvement of Maori health outcomes in screening, providing national monitoring and evaluation and quality improvement processes, purchasing provider services in accordance with provider agreements and robust financial and contract management.

13. What was the Gisborne Cervical Screening Inquiry?
In October 1999 the then Minister of Health established an Inquiry into the apparent under reporting of abnormal smears in the Gisborne region. The Inquiry also examined whether there was evidence of wider systemic issues for the NCSP that needed to be addressed.

The Inquiry found that during the 1990s the National Cervical Screening Programme in New Zealand lacked the necessary organisation, coordination and some of the constituent parts required for safe and effective screening programmes. Overall 46 recommendations were made by the Inquiry. Since then the NSU and other parts of the Ministry of Health have been working to implement the recommendations. Progress has been monitored, and has also been reviewed by an independent expert, Dr Euphemia McGoogan, who has reported twice to the Minister of Health. 

14. What can a cervical screening programme do?
International evidence suggests that morbidity and mortality from invasive cervical cancer can be reduced with organised screening that aims to detect and treat pre-cancerous changes to the cervix.

Screening for a disease reduces the risk of developing and/or dying from that disease. It does not eliminate that risk entirely. Therefore a cervical screening programme can only reduce the risk of a woman developing and dying from cervical cancer. It cannot eliminate it for all women. 

As it can take as long as 10 or more years for invasive cervical cancer to develop, and assuming ALL women aged between 20 and 69 years were routinely screened every three years, a cervical screening programme could theoretically achieve a 91% US Preventive Services Task Force. Guide to Clinical Preventive Services. 2nd edition. Washington: USPSTF; 1996. reduction in the incidence and mortality rate of squamous cell carcinoma over time.

Even with 100% coverage, a cervical screening programme is unlikely to be 100% effective for a number of reasons;

  • The screening test, the cervical smear, categorises women into those who have a relatively high risk of developing cervical cancer, and those who have a relatively low risk at a particular point in time. That is, it does not clearly divide women into those who will and those will not develop cervical cancer.
  • The limitations of smear taking mean that there will always be a proportion of smears that are difficult to classify even in the presence of rigorous quality assurance programmes.
  • The limitations of smear reading also mean that there will always be a proportion of “false negatives” (or “false positives)”, even in the presence of rigorous quality assurance programmes.

The validity of a screening test is measured by its ability to do what it is supposed to do, i.e. that it correctly categorises persons who have preclinical disease as test-positive (sensitivity) and those without the preclinical disease as test negative (specificity)2
It would be desirable to have a screening test that was both highly sensitive and highly specific. Usually this is not possible and there is generally a trade-off between the sensitivity and specificity of a given screening test. Hennekens,C H, Buring JE. Epidemiology in Medicine. Little, Brown.1987 The sensitivity of the cervical smear is quoted most frequently as 55-80%. US Preventive Task Force. Guide to Clinical Preventive Services. 2nd edition. Washington: USPSTF; 1996

In the case of the cervical smear test, this trade-off has to do with the fact that there are some smears that are clearly normal, some clearly abnormal, and some, which fall into the grey zone between the two. Hennekens,C H, Buring JE. Epidemiology in Medicine. Little, Brown.1987 

The cervical smear test is a screening test that involves subjective interpretation by a cytoscreener or pathologist of the 50,000 to 100,000 cells that are present on a typical cervical smear slide. There is an irreducible false negative rate of up to 20%. Although rescreening can reduce the false-negative rate, zero-error performance can never be obtained. Fitzgibbons PL. Austin M. Expert Review of Histologic Slides and Papanicolaou Tests in the Context of Litigation or Potential Litigation. Archives of Pathology and Laboratory Medicine – Volume 124, November 2000.

The finding of a false-negative cervical smear is not necessarily evidence of practice below the standard of care. The decision as to whether a false-negative cervical smear is the result of negligence should be made not only on the basis of an individual result, but also in the context of the laboratory’s overall performance on cervical smear tests. Fitzgibbons PL. Austin M. Expert Review of Histologic Slides and Papanicolaou Tests in the Context of Litigation or Potential Litigation. Archives of Pathology and Laboratory Medicine – Volume 124, November 2000.

15. How effective is the NCSP?
The NSU has established a range of quality activities that help ensure the safety and effectiveness of the NCSP for women. One of the most important indicators of overall programme effectiveness are disease incidence and mortality. The NCSP has achieved a 39 percent reduction in incidence and a 44 percent reduction in mortality from cervical cancer under the current enrolment system. 

Coverage is another indicator of NCSP effectiveness. The NCSP target for programme coverage is that the proportion of all 20-69 year old women who have had a cervical smear recorded on the NCSP-Register in the previous 36 months is 85% (adjusted for hysterectomy). Currently, approximately 73 percent of eligible women have had a smear in the last three years. This compares favourably with the three-year coverage rates from the UK (66%) and New South Wales (73%). As of October 2003, 1,097,788 women or 100 percent of the eligible population were enrolled on the NCSP-Register.

Women who have regular smear tests every three years as part of a screening programme reduce their risk of developing cervical cancer by about 90 percent.

Without Screening* With regular three-yearly screening*
1 out 90 women will develop cervical cancer 1 out of 570 women will develop cervical cancer
1 out of 200 women will die from cervical cancer 1 out of 1280 women will die from cervical cancer

*Estimated New Zealand figures

16. How have cervical cancer rates changed since the NCSP began?
Since the NCSP began there have been significant reductions in both the rates of disease and deaths from cervical cancer. Age-standardised incidence rates for cervical cancer have declined from 12.7 per 100,000 in 1990 to 8.2 per 100,000 in 1999. Age-standardised mortality rates for cervical cancer have declined from 5.0 per 100,000 in 1990 to 2.7 per 100,000 in 1999.

 

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