The practical implications, for both small and large laboratories, of the Renewed Cervical Screening program are significant. For over twenty years Pap smears in Australia have been a tried and true screening test with excellent quality standards, reported by well-trained scientists. With the introduction of Primary HPV testing on May 1 2017 conventional gynaecological cytology will be removed from Australia’s Medicare schedule. Cytology will still be used but it will be liquid based cytology either for reflex cytology with a positive HPV test or in special circumstances.

New laboratory equipment needs to be purchased and new workflows developed. The new systems that will be needed are not simple. Laboratory information systems which drive most pathology laboratories reporting systems will need to be completely rewritten. New request forms, and new report formats will be needed. They will need to incorporate all of the special circumstance provisions in the new management guidelines e.g. co-testing for women with abnormal bleeding.

One of the most significant issues for all laboratories is the reduction in staff numbers. Only one out of six scientists currently screening cervical cytology will be needed in the new program. Various options exist for these highly trained people but this represents a major shift in work practices. Pathologists and scientists skilled in interpretation of gynaecological cytology will still be needed however, especially where difficult cases need to be reviewed. Continued training in gynaecological cytology will be necessary for scientists and pathologists.

Significant quality assurance measures will be needed to ensure that this testing is done at the highest standard. Quality standards need to take into account that HPV testing is a screening test not a diagnostic test. Laboratories will need to implement these significant changes and comply with these quality standards.

Pathology laboratories will send and receive patient data to and from the new National Cancer Screening Register (NCSR) which will allow appropriate patient management. The NCSR will also be providing crucial data for the important quality assurance processes. This will be part of the new computer programing required for all laboratories.

The degree of difficulty for laboratories has been increased due to the slow release of information that allows them to implement these changes. These changes are also further complicated by the government decision to invite all women due for screening in the first two years. The numbers of patients in subsequent years will then fall significantly to rise again at the commencement of the next screening round. Staff will not be able to be continued to be employed and laboratory equipment will need to be deployed in other areas. This creates significant quality implications for the future screening rounds. Pathology labs may face consolidation and eventually testing may not be available in all states.