Updated 21:50

The man in charge of the Cervical Check inquiry says there were indications it was a system 'that was doomed to fail.'

Dr Gabriel Scally has been reviewing the cases of 209 women who received false negative results from the State's national screening programme.

They were not informed when the issues were brought to light by an internal audit.

In his report, Dr Scally says: "This major crisis emerged into the public domain because of a failed attempt to disclose the results of a retrospective audit to a large group of women who had, unfortunately, developed cervical cancer.

"In particular, it emerged because of the extraordinary determination of Vicky Phelan not be silenced.

"But there are many indications that this was a system that was doomed to fail at some point.

"Screening services are sometimes finely balanced in terms of benefit and harm and can act as an early warning sign of wider systemic problems."

Dr Scally has issued 50 recommendations, which include reviewing the HSE’s disclosures policy.

Reaction

Several of those affected by the CervicalCheck scandal have been welcoming the comprehensiveness of the report.

Stephen Teap - whose wife Irene died from cervical cancer - says the main priority now has to be fixing the system as quickly as possible.

He observed: "You have no idea of the emotional pain that we felt yesterday going through this inquiry.

"It is horrific for us to read - particularly for myself, when I see exactly how the ending of Irene's life could be summed up in this. She did everything right - she got her smear test done, she put her 100% faith and trust in the system."

Vicky Phelan, meanwhile, reacted to the report on the Hard Shoulder.

Vicky Phelan. Image: Sam Boal / RollingNews.ie

She argued: "I know there are women within the group who will not be happy with this, because they're angry - and I don't blame them.

"At the very beginning, I was exactly the same - I was looking for accountability, and I got some of it with [former HSE chief] Tony O'Brien stepping aside and [Cervical Check clinical director] Grainne Flannelly stepping down.

"When I got this report yesterday and I read about the absolute omnishambles that Cervical Check was really... Scally said it himself: they were doomed to fail. It was going to happen at some stage - my case brought it out, but it was going to happen."

Serious gaps

The review highlights "serious gaps" in the screening programme.

Dr Scally says: "It is apparent that there are serious gaps in the governance structures of the screening services.

"In the specific case of Cervical Check, there was a demonstrable deficit of clear governance and reporting lines between it, the National Screening Service and the higher management structures of the HSE.

"This confusion complicated the reporting of issues and multiplied the risks.

"It is clear that there are also serious gaps in the range of expertise of professional and managerial staff directly engaged in the operation of Cervical Check.

"There are, in addition, substantial weaknesses, indeed absences, of proper professional advisory structures.

"These deficiencies played no little role in the serious issues that concern this Scoping Inquiry.

He adds: "I am satisfied with the quality management processes in the current laboratory sites i.e. CWIUH, Quest, and the Sonic Healthcare Laboratories, namely MLP and TDL.

"I am also satisfied that the quality management processes were adequate in the former provider, CPL in Austin, Texas, part of Sonic Healthcare."

Overhaul

The report also says that the programme should be overhauled.

It says: "Within three months of the publication of the Scoping Inquiry report, there should be an independent review of implementation plans to be produced by each State body named in this report, in respect of the recommendations contained herein.

"The findings of this independent review of implementation plans should be submitted to the minister and published.

"Thereafter, there should be a further review of progress reported to the minister at six monthly intervals and published."

However Dr Scally adds: "The continuation of cervical screening in the coming months is of crucial importance.

"My Scoping Inquiry team has found no reason why the existing contracts for laboratory services should not continue until the new HPV regime is introduced.

"This new approach of HPV testing will significantly improve the accuracy of the screening process, increasing the chances of more cancers being prevented due to the detection of early changes."

Recommendations

Dr Scally has made 50 recommendations - but has not singled out anyone for blame.

His team has interviewed all of the key stakeholders and visited the labs used by the screening programmes.

He has also scrutinised some 13,000 pages of documents.

Among the recommendations are that Cervical Check should revise its programme standards to clarify what is mandatory, and to clarify the level of reliance on external accreditation processes.

"This is particularly important in respect of laboratory service providers in other jurisdictions", the report says.

"As a priority all providers should fully implement a single agreed terminology for the reporting of results and ensure that criteria for defining the different grades of abnormality are consistently applied.

"Based on revised programme standards, a specification for a new and more robust quality assurance procedure should be documented and form part of the contract for services with cytology providers."

It also says that Cervical Check should adopt "a formal risk management approach" to parameters which do not reach acceptable standards despite full intervention and monitoring.

Cervical Check should document, it says, which organisation (e.g. CervicalCheck, HSE or providers) has responsibility for pursuing issues of continued non-compliance and the consequences thereof.

It adds that an advisory group of cytopathologists and other laboratory-based staff should be established to advise on this process.

Independent Patient Advisory Council

The Health Minister Simon Harris has not ruled out setting up a Commission of Inquiry.

But he has welcomed the report and says he is committed to implementing the 50 recommendations.

Speaking to Dr Ciara Kelly on Lunchtime Live, Mr Harris says: "He talks about the need to enhance the voice of the patient - so I've decided today I'm going to establish an Independent Patient Advisory Council - and I'll bring proposals on that next month".

"He talks about the need for the Medical Council to tighten up its own guidelines on open disclosure, so that doctors have absolute clarity.

"He want us to legislate for duty of candour so that it's not optional as to whether you tell the patient when something seriously goes wrong - and there are many, many other recommendations as well in relation to procurement, in relation to the governance structure of screening, having a national director of screening so there's one individual in charge of it.

"There's definitely a lack of role clarity in there."

Additional reporting by Stephen McNeice