Address by Dr Tony Holohan, Chief Medical Officer, Department of Health to the Oireachtas Health Committee on issues surrounding the CervicalCheck Programme
Check against delivery
Thank you Chair for the invitation here today.
I would like to start my opening statement by acknowledging the important role Ms Vicky Phelan has played in highlighting a number of major weaknesses in relation to how people have experienced our national cervical screening programme, CervicalCheck. The Minister has publicly committed to swift action to address these issues.
Ms Phelan was diagnosed with cervical cancer in July 2014, and sadly, was informed in 2017, that her cancer is incurable. In 2014, CervicalCheck’s clinical audit of Ms Phelan’s 2011 smear test result, which was reported at the time as normal, identified a “query squamous cell carcinoma“. However, Ms Phelan was not made aware of this finding until September 2017. This delay has raised very serious concerns around the processes for providing information to both patients and clinicians.
Subsequent to the controversy surrounding Ms Phelan’s case, the HSE initially advised that, between 2008 and early 2018, 1,482 cervical cancer cases were notified to CervicalCheck. The majority were women who had already been referred for further investigation or treatment by CervicalCheck. As part of the clinical audit process, these notified cases were re-examined and 277 cases were flagged for further cytology review. In 208 of these 277 cases the cytology review recommendations differed from the original test.
On Friday 27 April, the HSE established a Serious Incident Management Team to oversee and direct the management of this incident. The SIMT has reported that approximately 162 of the 208 women involved had now been informed of the outcome of the audit process. Communication with these women is on-going. I regret to say that 17 of the patients involved are deceased and I wish to express my sympathies to their families.
Arising from the work of the SIMT, as outlined by the Minister last night, the number of cases of cervical cancer notified to CervicalCheck (1,482) does not represent all cases of cervical cancer occurring in Ireland since the establishment of the CervicalCheck programme in September 2008. I regret to say that I do not have the necessary information at this stage to confirm how many additional cases this might represent, but work has started today to ascertain this number.
The Minister has directed that immediate steps be taken so that information from the National Cancer Registry can be provided to the CervicalCheck programme on any additional cases of cervical cancer that occurred during this time period. The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme, their case will be reviewed in further detail with cytology review where necessary.
A helpline has been in operation since Friday and appropriate clinical staff will follow up with women on their specific clinical questions. The helpline received 2109 calls yesterday.
Since 2008, some 3 million smear tests have been carried out by CervicalCheck. It is very important to note that the cervical screening test is not a diagnostic test. It is only a screening test, that is, a test to indicate the possibility of precancerous or cancerous lesions and thereby identify women who need to be referred for further investigation or follow-up. Smear tests can produce both false positive and false negative results. Therefore, cervical cancer may well develop in the time interval between a negative screening test and the next scheduled screening in any cervical screening programme. The current primary screening test used by CervicalCheck is a cytology test which is known to have low sensitivity i.e. it produces a not insignificant number of false negative results.
Naturally, many women are now concerned about their own health following the publicity surrounding CervicalCheck. In order to provide assurance, CervicalCheck will make the necessary arrangements to enable any woman who has had a CervicalCheck smear test, to have a consultation with her GP, in order to help her determine whether she wishes to have a further test without charge. These arrangements are currently being worked through and will be confirmed this week.
In addition, in February 2018, the Minister approved the introduction of primary HPV screening for cervical smear samples and I can confirm that primary HPV screening will be introduced later this year. A HIQA Health Technology Assessment has found that HPV screening would benefit women by making the screening process more clinically effective as well as reducing unnecessary tests for most women.
I would now like to turn to the steps that are being taken to ensure the integrity of the CervicalCheck screening programme. Non-disclosure of information to affected patients has raised concerns for users within the health service.
Patients have a right to be provided with honest, open and prompt communication about any adverse event that may have caused them harm. This is underpinned in the Medical Practitioners Code of Conduct and the HSE Open Disclosure Policy. The Civil Liability (Amendment) Act, which includes provisions that support open disclosure, became law last year. These provisions were drafted to create a safe space for staff to be open and transparent with patients in order that they would be given as much information as possible, as early as possible, including an apology where appropriate. By doing this, we have taken away any fears that doctors may have to being open and apologising to patients. There is no longer room for excuses. The patient has a right to know and should be told.
The next step is then to further strengthen and protect open and honest communications between patients and the health service by bringing forward proposals for mandatory open disclosure for serious reportable events. A stand-alone Patient Safety Bill goes to government next week to expedite this.
The Minister’s intention is to have an independent statutory investigation to examine the CervicalCheck screening programme. This investigation will have all the necessary powers to investigate the issues highlighted by Mrs Phelan and will place particular focus on the quality assurance systems, clinical audit processes and communications with patients within the cervical screening programme.
As part of this, a comprehensive examination of the cervical screening programme in Ireland against international best practice and standards will be undertaken. The investigation will also identify, within its terms of reference, any implications that may apply to other cancer screening programmes.
In addition to this statutory investigation, we are now working on putting in place, as a matter of urgency, an International Clinical Expert Panel to provide the women concerned with an individual clinical review. This Clinical Expert Panel will also produce an overall report to inform the statutory investigation, and the work of the International Peer Review Group. We are mindful of the need to provide support to these women and a liaison nurse specialist will co-ordinate the work of the Expert Panel.
Cervical cancer is the second most common cause of death due to cancer in women aged 25 to 39 years. Every year in Ireland approximately 270 women are diagnosed with cervical cancer and 90 women die from it. Cervical cells change slowly and take time to develop into cancer cells, making cervical cancer a preventable disease. Even with the inherent challenges in screening, having regular smear tests can pick up early cell changes (precancerous growths) and reduce the risk of cervical cancer. I must emphasise how important it is that women continue to have their smears and take this test, which can and will continue to save lives.
In conclusion, it is our intention to take these necessary steps in order to ensure the integrity of the cervical screening programme while at the same time disseminating any learning to all cancer screening programmes. These programmes are an important component of the progress that we have made over the last 10 years in cancer survivorship for our citizens. The Department is fully committed to the further development of our cancer services and to delivering the ambitious roadmap set out for these services as outlined in the National Cancer Strategy which was launched last year.