I propose to take Questions Nos. 1769, 1770, 1773 and 1774 together.
In late 2018, Quest Diagnostics informed the HSE of a number of HPV tests done outside the manufacturers' recommended timeframe. While the clinical risk was low, as advised by the HSE, around 4,000 women who had previously tested HPV negative were invited for a further smear test as a precaution.
In addition, a number of women affected by this issue had their existing samples retested with a different type of HPV test, the HPV DNA test, which has a longer expiration period. Both tests are acceptable and are used in international screening programmes. The use of this test meant that women were not required to attend their GPs for a repeat smear test.
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. This issue related to approximately 850 women, although it should be noted that final figures remain to be confirmed by the HSE in association with Quest.
Within this, approximately 52 women tested positive for the HPV virus on retest. This meant they required a different care pathway than if they had tested negative. The HSE has advised that these women's GPs received the women's results in February, and that it has been in contact with the GPs of all of these women and affirmed they are on an appropriate care pathway.
In regard to the remaining women, who have had no change to their results or care pathway, the HSE has advised it will write to them apologising for the delay in advising them that their HPV results remain unchanged.
These retests were undertaken by Quest Diagnostics at a quality assured laboratory in Chantilly, which is approved by the HSE for HPV testing for CervicalCheck work, including the retests in question, and which forms part of the additional capacity secured by CervicalCheck to meet the programme's needs on an ongoing basis. The HSE advises this facility currently provides only HPV testing for CervicalCheck, which is one part of the overall cervical screening test process.
In regard to the way in which this IT issue occurred, and mechanisms to prevent a re-occurrence, the HSE CEO has commissioned an immediate rapid review of this incident, and appointed Professor Brian MacCraith as the independent external chairperson. The review is expected to be complete and provided to the HSE by 2 August, and the HSE has indicated its intention to publish the report. The rapid review will provide a report to the HSE’s CEO setting out the facts relating to the incident and to make recommendations for any appropriate further actions and future learning.
A HSE Serious Incident Management Team (SIMT) is in place to manage the response to this incident, and is continuing to engage with Quest Diagnostics to ensure final confirmation of the numbers affected by any delay in issuing results letters, to ensure all necessary communications to women and/or their GPs have taken place, and to report at the conclusion of the incident.