Design Gisborne Cervical Screening Inquiry
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Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region

7. Term of Reference Four

What changes have already been made to legislation, to laboratory or other processes, or to professional practices, to address the risks of under-reporting of abnormalities in cervical smears?

The Committee has interpreted this term of reference as applying to those changes that have been made since Dr Bottrill retired from practice which will address the risk of under-reporting of abnormalities. Therefore, the Committee will address changes made after March 1996. Some of these changes have already been referred to in other sections of the report.

Changes To The Programmeís Components

7.1 The changes include an ability to co-relate histology results with cytology results (achieved in 1996); the reconfiguration of the 14 stand-alone screening registers into a centralised register (achieved in 1997). It is now possible for a laboratory that reads the cytology to request a correlation report between a patientís cytology and histology. The report gives details of the histology results for all women for whom the laboratory in question has read a cytology result within five years prior to a high-grade histology result. Where there has been a negative smear report within five years prior to a high-grade histology result that information is automatically highlighted. Unfortunately s.74A limits others having access to this information. Access to information about identifiable women on the Register is limited to the woman, her smear-taker and the laboratory reading the smear test.

7.2 Since the Register has been reconfigured the data held on it is more reliable as a result of the centralised system which has reduced the opportunity for regional deviation. Technically data is now more easily available and more reliable for the purpose of statistical analysis.

7.3 Since 1996/1997 TELARC/IANZ accreditation or accreditation with a similar authority has been compulsory for laboratories reading cervical cytology. This change was introduced through the Policy 1996 requiring laboratories to be accredited. The Policy was made a term of the funding agreements between the Ministry of Health and the regional health authorities. The regional health authorities then made compulsory accreditation a condition of payment under their agreements with the laboratories. As each regional health authority completed its funding agreement with laboratories at a different time the Committee cannot report precisely on the dates when all regional health authorities completed these agreements. In the case of the Midland Regional Health Authority the agreement was executed in March 1997. The evidence the Committee has heard is that by 1997 all laboratories reading cervical cytology were legally required to be accredited. In fact all the laboratories reading cervical cytology had been accredited since February 1996.

7.4 The Committee considers that compulsory TELARC accreditation would have reduced the unacceptable under-reporting of abnormalities in Gisborne, because it would have prevented those practices of Dr Bottrill that are likely to have led to under-reporting. In a more general sense, although TELARC/IANZ accreditation can reduce the likelihood of under-reporting, errors can still occur in accredited laboratories. Accreditation is focussed on process as opposed to assessing the substantive quality of the work being performed. Accreditation can influence the substantive quality by putting in place procedures that are likely to assist in good performance but that is all it can do. Accreditation is not a substitute safeguard for comprehensive monitoring and evaluation. The work of accredited laboratories must still be checked.


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