The Director General of the Health Service Executive has said there was no question of anyone in the CervicalCheck programme seeking to withhold information about cancer diagnoses.

Tony O'Brien said the clinical review of cases was triggered by cases of cancer.

He said the controversy was not about poor laboratory performance but a communications problem around an audit process.

He added that the HSE's corporate policy was to be open and he was unambiguously in favour of a mandatory duty of candour.

Speaking on RTÉ's Today with Sean O'Rourke, Mr O'Brien said it was an issue of concern and disappointment that he was not informed of Vicky Phelan's case, but this was secondary to the work of the serious management team, dealing with cases and restoring confidence in the CervicalCheck programme.

He said that a case management will be undertaken to find out why Ms Phelan's case was not escalated in the way it should have been.

Mr O'Brien also said the fact that he used to be the director of CervicalCheck made this issue quite personal for him.

Smear testing for CervicalCheck is carried out by two laboratories in Dublin and one in the United States.

The tests are done at the Coombe Women and Infants University Hospital and USE MedLab Pathology Ltd in Sandyford, both in Dublin, and at Quest Diagnostics Inc, Teterboro, New Jersey.

Mr O'Brien said that, by international benchmarks, the labs were performing as they should be and were subject to high quality standards.

In addition, he said the US lab was only dealing with Irish patients and Irish smear tests were not being mixed in with a greater cohort of US patients, who are tested yearly.

He stressed the smear test was not a diagnostic test, but a screening one and there was no laboratory in the world that can provide 100% accuracy on that type of cytology.

Mr O'Brien explained that liability arising from an error, outside the acceptable margin of error, would lie with the laboratory.

He said the HSE was working hard to restore confidence in the programme.

Mr O'Brien said this included new clinical governance and the establishment of a helpline to offer reassurance to women. He said anyone that wanted their case to be re-examined would be accommodated. 

He said the explanations by Professor Grainne Flannelly, the former Clinical Director of CervicalCheck, while not satisfactory, were the truth. He said she stood down because she was deeply committed to the programme and wanted to help restore confidence in it.

Mr O'Brien said there would not be a programme without her commitment over the last number of years. He said he spoke to Professor Flannelly at length before she announced her resignation.

Meanwhile, Sinn Féin leader Mary Lou McDonald has called for Mr O’Brien to resign or be sacked.

She said he had ignored advice from experts who advised that the outsourcing of screening tests to laboratories in the US would cost lives.


Read more:

Taoiseach moves to reassure women over CervicalCheck
What is the CervicalCheck controversy about?
17 women affected by CervicalCheck controversy have died
Misdiagnosed cancer patient critical of minister


The Head of Services and Advocacy at the Irish Cancer Society has described the lack of communication as bordering on breathtaking.

Speaking on the same programme, Donal Buggy said there needed to be accountability.

Mr Buggy said we need to establish who knew what, and when, as well as who decided not to inform the women of the clinical audit.

He said public confidence needs to be restored in Ireland's cancer screening programmes.

State Claims Agency defends its handling of cases

In the wake of the controversy, the State Claims Agency has issued a statement on how it manages clinical negligence claims.

A spokesman said: "The agency is conscious that, while it has a statutory duty to act in the best interest of taxpayers, it also has a duty towards people who have suffered from medical negligence or misdiagnosis and who take legal actions against the State or State bodies.

"[It] is acutely conscious that in many cases these people, together with their families, have suffered significant trauma and pain.

"Recognising this, the agency aims to act fairly, ethically and with compassion in its dealings with these people and their families and in the management of all cases that fall within its remit."

However, it said the agency is required to operate in accordance with its statutory mandate to investigate claims thoroughly and to manage litigation in a professional manner.

The SCA pointed out that, in Ms Phelan's case, another party accepted responsibility for the primary legal issue - that Ms Phelan's smear test was misread.

It said: "The High Court judge who presided over the settlement said this case was handled in an 'efficient and humane' manner, noting that it was settled within approximately 10 weeks of the summons being issued as a result of the parties pulling out all the stops.

"The SCA does not intend to fully defend any case of this nature where responsibility is substantially or completely that of the State - in such cases it would pursue other options, including mediation or settlement."