A check-up for CervicalCheck: where are we now?

In December of last year, Taoiseach Leo Varadkar stated publicly that the CervicalCheck scandal was his single biggest regret of 2018. “In terms of the low points, I don’t know of any one particular day, but definitely trying to understand and manage and respond to the CervicalCheck scandal was extremely difficult,” he said. The controversy surrounding false negative results, the HSE’s policy of open disclosure and the trauma experienced by individuals such as Vicky Phelan, gripped the nation and raised serious questions about the state of the Irish health system. Since then attempts have been made to understand what went wrong, what recommendations were made in the wake of the scandal, and how successful the Department of Health have been in implementing these proposals to date.

Cervical cancer is a cancer that affects the cell-lining of the cervix in women. Warning signs include abnormal vaginal bleeding and pelvic pain. The main methods of treatment for this cancer are radiotherapy, chemotherapy and, in some cases, a hysterectomy (the surgical removal of the uterus). Each treatment option works most successfully with the earliest possible diagnosis of the cancer, making screening programmes invaluable. Delayed diagnosis results in the disease progressing into higher stages, leading to substantially reduced survival rates.

In September 2008, the Irish government introduced the CervicalCheck scheme, a screening programme for cervical cancer that was to be made available to 1.1 million eligible women between the ages 25 and 60. Since 2008, it is estimated that over 280,000 women have been screened per year. The procedure, which is commonly referred to as the “smear test”, is both quick and painless and involves the removal of a small tissue sample from the cervix. This sample is then assessed using cytological and morphological comparisons in a laboratory. The Cervical Check scheme outsourced the testing of these tissue samples to Clinical Pathology Laboratories in Austin, Texas between 2010 and 2013. However when investigations began shortly after the Cervical Check scandal broke, it was discovered that a third of smears were being outsourced further, to five labs all over the United States of America; San Antonio and Victoria in Texas, Las Vegas in Nevada, Orlando in Florida and Honolulu in Hawaii.

In 2011, Vicky Phelan underwent a routine smear test, the results of which showed her to be “all clear”, in other words; no cancer had been detected. This result was however, a “false negative”. A false negative occurs when the results of a test indicate that the disease is not present, when in reality, it is. A 2014 audit of smear test results undertaken by the HSE revealed that she had wrongly received the all-clear. Shockingly, Ms Phelan was not informed of this error. In 2014, after seeking medical assistance independently, she was diagnosed with cervical cancer. Following aggressive radiotherapy and chemotherapy treatments, Vicky Phelan was declared cancer free later that year. However, in November 2017, a routine scan revealed that her cancer had returned. While undergoing treatment that year, Ms Phelan discovered from a chance reading of her medical records that the 2011 smear test had missed her cancer and even more damningly, that she had not been informed by anyone about this. Some months later, Ms Phelan settled a High Court case against Clinical Pathology Laboratories for €2.5 million with no admission of liability.

These developments gained significant media attention. On the 27th April, Minister for Health Simon Harris stated that he no longer had confidence in the management of the CervicalCheck programme. Following this, the HSE admitted that it had been aware of the substandard examination of smear test samples in the US laboratories in 442 cases, 200 which should have resulted in earlier intervention. It was revealed that the Clinical Director of CervicalCheck, Dr Gráinne Flannelly advised gynaecologist Dr Kevin Hickey in a 2017 email not to inform several women of false negative test results discovered in an audit and that he should “simply file” the audited test results in the patients’ medical records. Dr Gráinne Flannelly resigned soon after these revelations emerged. A helpline was set up by the HSE to address concerns and received 2000 calls over the space of two days. The former Chair of the National Cervical Screening Programme, Dr David Gibbons, said that he had repeatedly voiced his concerns to the HSE regarding the standard of testing in the US laboratories, all of which were ignored. On 1st May 2017, Minister Simon Harris announced to the Dáil that an additional 1,500 women suffering from cervical cancer did not have their earlier negative smears rechecked. He also suggested that the Government establish an investigative commission into the affair.

The Department of Health commissioned Dr Gabriel Scally to publish a report detailing how these mistakes were made and to draw up a list of recommendations as to how a similar scandal could be avoided in the future. The “Scoping Inquiry into the CervicalCheck Screening Programme” revealed serious failures in the governance structures of the programme, leading Dr Scally to conclude that the scheme was “doomed to fail”. It is abundantly clear from the Scally Report that a great injustice was done to the women affected by this scandal, particularly in regard to the non-disclosure of the information gathered from the audits. Many who were involved are still suffering from cervical cancer and undertaking active treatment. Other women, despite having received effective clinical intervention, continue to suffer from the life-altering effects of the disease and treatment such as hysterectomies, chemotherapy and lasting psychological damage. They have been forced to come to terms with difficulties such as infertility, lymphoedema, incontinence, and sexual problems.

Many of those affected by the scandal are seeking more than just a financial settlement, stating that they only pursued legal action out of anger and frustration at the Health Service’s response. The Scally Report outlined three recommendations made on behalf of the women affected. Firstly, the women are seeking full disclosure regarding what happened and what went wrong. Secondly, they want someone to take responsibility and issue a genuine apology. The final recommendation was for measures to be put in place to ensure something like this never happens again. These measures included changes to document management policy within the HSE, the implementation of common standards across all testing laboratories and the formation of a National Screening Council. The report called for urgent revision of the HSE’s open disclosure policy. The revised policies must reflect the fundamental right of patients to have full knowledge about their health and also failings within the care process. Any decision not to disclose an error or mishap to a patient must be subject to intense external scrutiny and fit very specific criteria.

The report suggested that a lack of professionalism and compassion among medical professionals contributed to the tragic course of events. The decision not to disclose potentially life altering information raised concerns among the general public over the practices and attitudes of the medical profession in Ireland. Efforts have been made by UCD’s own School of Medicine in an attempt to address this. “It is important that students learn from the errors in communication that occurred in the CervicalCheck controversy” the Dean of Medicine, Professor Michael Keane, commented. Several lectures have been given directly referencing the scandal and the subsequent Scally Report. These lectures involve concepts such professionalism, compassion fatigue and the importance of an open dialogue between doctors and their patients. But these efforts in themselves raise another question, namely; Can compassion and empathy be learned from lecture slides?