The resignation of Dr Gráinne Flannelly as clinical director of CervicalCheck is an important first step in the restoration of public confidence in our national cervical cancer screening programme. It follows revelations in the High Court that Limerick woman Vicky Phelan was not informed about an incorrectly reported 2011 smear test until 2017, despite a 2014 audit by CervicalCheck showing that the test analysis was wrong.
Dr Flannelly’s inability to say whether all 206 women identified in the look-back as having received a false negative result had been made aware of their changed diagnosis raised alarm bells. Subsequent confirmation that a number of these women have died has shaken public confidence in CervicalCheck.
False positives and false negative results are inherent features of health screening programmes worldwide. Efforts to minimise their effects include repeat screening, double -reading of slides, and an ongoing quality control benchmarking of laboratories.
These limitations notwithstanding, regular cervical screening, along with the HPV vaccine, is the most effective way for a woman to reduce her risk of cervical cancer. Since its establishment in 2008, CervicalCheck has detected over 50,000 pre-cancerous changes in women without any symptoms, reducing their cervical cancer risk by 90 per cent, while cervical cancer rates in Ireland have decreased every year since 2010.
However, the most worrying aspect of the scandal is the exposure of poor governance within CervicalCheck. As evidenced by correspondence in the Vicky Phelan case, the lack of understanding of the need for open disclosure some 10 years after the programme was set up is shocking.
Open disclosure requires healthcare professionals to inform patients, as soon as is practicable, of problems with test results, changes in diagnosis and any errors associated with their management. The principle of open disclosure was introduced almost two decades ago and is now accepted globally. It is specifically outlined in the Medical Council’s code of ethics.
This is not the first health scandal of recent years to involve a failure to be open and honest with patients. In the wake of each one we were assured by different ministers for health and the HSE of a renewed voluntary commitment to open disclosure.
Continued failure to honour this commitment means the time has come for duty of candour legislation to be enacted. This must outline clearly the duties and responsibilities of healthcare professionals when adverse events occur. It must enshrine the principle of full patient ownership of their medical notes.A formal assessment of the effectiveness of the National Cancer Screening Service must also occur.