Acknowledgment of health service errors key to minimising harm

An error made in the reading of Vicky Phelan’s cervical smear sample, by a US laboratory in 2011, meant that she received no follow-up treatment after this smear test. This error was identified by a quality audit carried out by CervicalCheck in 2014 which revisited smear test results of women who were subsequently found to have cancer.

In 2016, a CervicalCheck decision was made to inform patients of errors found in the 2014 audit. CervicalCheck communicated this wrongly read result to Phelan’s doctor in 2016 without clarity on how best to do this, resulting in a stand-off between her doctor and CervicalCheck which meant this mistake was not communicated to her.

In 2014, Phelan had her next regular smear test which indicated she might have cervical cancer. A further test confirmed this, after which she began her cancer treatment. She only found out about the 2011 error while browsing her file waiting hours for an appointment in September 2017.

Not telling Vicky Phelan in 2014 about the error in her 2011 scan did not delay her treatment after 2014. But it demonstrates a total failure of CervicalCheck and the Health Service Executive to operate their own open disclosure policy. Open disclosure of all errors, even when harm has not occurred, has been HSE policy since 2013.

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Her case might  encourage politicians to change the law and end the adversarial nature of medical negligence cases, in which there are no winners but lawyers' bank accounts

Not telling Phelan was wrong and has greatly added to the extremely stressful situation she is now in. It is also evidence of botched clinical governance structures within our health system. Not communicating these wrong smear tests to hundreds of other women, over a dozen of whom are now dead (the exact numbers remain unknown), is not just terribly distressful for these women and their families, it exposes a paternalism that persists in the medical profession.

Screening services

Ireland came late to cervical screening in 2008, about 30 years behind most other European countries, when it was eventually rolled out as a national programme. All screening services are imperfect. Screening does not pick up on all potential cancer cases but screening does save lives.

Since the introduction of the programme, 50,000 women have received treatment having been picked up with pre-cancerous or cancerous cells by CervicalCheck. This has resulted in a 7 per cent reduction in cervical cancer incidence over nine years. Calls for more regular screening are misplaced. There is little or no gain for more regular screening than we currently have – it mostly leads to women coming in for unnecessary investigations.

Screening is an imperfect science carried out by fallible human beings, so errors do occur. But when they do, the important thing is to acknowledge these errors and not cause further harm. International experience in remedying a loss of trust after mistakes are made shows that there needs to be a quick, sincere apology and an explanation given to the patient by the people involved in the mistake, backed up with evidence that systems are being changed to ensure it won’t happen again. This obviously did not happen for Vicky Phelan.

Her public courage and the controversy that has ensued has shaken public confidence in CervicalCheck. When a crisis in confidence in essential public health services like this arises, what is needed is clarity of message and facts. Initial interviews by the head of the Cancer Control Programme, Jerome Coffey, and former CervicalCheck medical director, Gráinne Flannelly, exacerbated existing misinformation and confusion.

While the most senior health service personnel and Department of Health officials have come out this week, they were very slow to respond and take responsibility for Vicky Phelan’s experience and the public crisis in confidence that has followed.

Medical negligence

Each time there is another medical scandal, politicians promise that reporting of adverse incidents and medical errors will be mandatory. Yet, Fianna Fáil abstained and Fine Gael voted against this very legislation in the Dáil last November, amending it to voluntary not mandatory open disclosure. Phelan’s case will now see mandatory disclosure happen. Her case might also encourage politicians to change the law and end the adversarial nature of medical negligence cases, in which there are no winners apart from lawyers’ bank accounts.

What is most important now is that women's lives are saved and not lost as a result of this controversy

A statutory investigation is being set up, which in time will bring answers to key questions: is it the right decision to outsource smear tests to laboratories in the USA? Could these errors have been prevented? Why were patients not clearly and promptly informed of errors when they were discovered in the CervicalCheck audit? How did such a failure of clinical governance and open disclosure occur? Who should and will be held accountable for this?

A decade ago, the country was mired in a series of cancer misdiagnoses scandals. Then minister for health Mary Harney acted and these scandals combined with her political leadership and the establishment of the Cancer Control Programme can be credited with huge improvements in all public health cancer services resulting in much better outcomes for Irish people.

What is most important now is that women’s lives are saved and not lost as a result of this controversy. This requires political leadership, clarity from the health services at every level and sticking to the facts rather than the distortion of realities that tends to prevail when controversies such as this hit the headlines.

Sara Burke is a health-policy analyst at Trinity College Dublin