The Deputy will be aware that, where low grade changes are detected on a cervical smear test, a second, so-called ‘triage test’ - which looks for the HPV virus - is carried out by laboratories.
If HPV is found, women are recommended to attend for further testing (colposcopy). If HPV is not found, women are recommended to attend for routine screening again in 3-5 years.
Earlier this year, the HSE, working with Quest Laboratories, identified a situation in relation to the HPV testing. In this laboratory, the manufacturer’s recommendation is that the test for HPV should be carried out within 30 days of the sample having been given by a woman.
Of the approximately 500,000 samples tested by Quest since 2015, the HSE advised that a proportion of these HPV tests had been performed outside of the recommended 30 day timeframe. Approximately 4,200 women were invited to attend for a retest and approximately 3,000 women took up that offer. The section of the webpage referred to by the Deputy is in reference to this issue. The webpage states that the HSE had also contacted the other two labs which provided services to the programme to ensure that this issue did not occur with them. These labs are the Coombe Women and Infants University Hospital and MedLab Pathology Ltd., as both of these labs were providing services for CervicalCheck at that time.
This is separate to the current issue in relation to delays in reporting test results for a particular cohort of women affected by the HPV expiration issue, which is also referenced on the same webpage. A number of women had their existing samples retested with a different type of HPV test, the HPV DNA test, which has a longer expiration period. The use of this test meant that women were not required to attend their GPs for a repeat smear test. Both tests are acceptable and are used in international screening programmes.
The HSE advised the Department on 10 July that the IT system in the laboratory undertaking these retests required updates to ensure electronic issuing of results letters and that, as these updates could not be completed in time, letters were to issue manually to GPs. Regrettably, this had not happened in all cases.
The HSE has apologised for this issue, and has affirmed that the clinical risk to the women affected is low. A HSE Serious Incident Management Team (SIMT) is in place to manage the response to this incident, and to ensure all necessary communications to women and/or their GPs have taken place.