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Government looks at bringing in mandatory open disclosure in serious cases

“Open disclosure is not the ticking of a box or the filling of a form,” Ireland’s chief medical officer said.

Vicky Phelan at Leinster House with Stephen Teap, whose wife died before she was told that her smear test had been wrongly interpreted.
Vicky Phelan at Leinster House with Stephen Teap, whose wife died before she was told that her smear test had been wrongly interpreted.
Image: Brian Lawless via PA Images

THE DEPARTMENT OF Health is drafting a form of mandatory open disclosure as part of the fallout from the CervicalCheck controversy.

The Secretary General of the Department of Health Jim Breslin said today that “in serious incidents such as this”, it would be mandatory for medical professionals to recount errors in judgement or mistakes.

A document outlining regulations, including mandatory open disclosure, has been drafted by the Department of Health and being conferred with a number of bodies representing healthcare professionals, as well as Hiqa and the Medical Council.

The Chief Medical Officer Dr Tony Holohan, told the Public Accounts Committee this morning that work was ongoing at the Department to push for open disclosure to be mandatory in serious cases, but that it was a delicate process to implement it.

The HSE defines open disclosure as “an open, consistent approach to communicating with service users when things go wrong in healthcare”.

“We want to be able to ensure that when things go wrong when treating patients that doctors without fear of an apology creating risks for them, can support patients actively though that.”

He said that in his experience of reviewing patient safety incidents was that at “the very moment of harm”, doctors can step away from patients out of fear, “in the very moment that patients need them”.

“Open disclosure is not the ticking of a box or the filling of a form, it’s helping a patient through a journey and beginning to understand what happened.”

Although the HSE has a culture of open disclosure, the political decision was taken to not make it mandatory “for fear of litigation” that may arise through the admission of mistakes or misjudgements.

While serving as Minister for Health, Leo Varadkar had plans to introduce mandatory open disclosure, but rowed back on that after advice from the Tony Holohan.

In March 2017 Health Minister Simon Harris received approval from Cabinet to bring in a voluntary form of open disclosure where medical professions would be protected from legal action for any information given following a patient safety incident.

Quick recap on what we know

The conclusion of Vicky Phelan’s court case last month revealed that at least 209 women had had their smear tests incorrectly interpreted and weren’t told by the screening programme or their clinicians.

The revelations since have led to Grainne Flannelly to step aside as the director of CervicalCheck and HSE Director General Tony O’Brien to resign from his post.

In Vicky Phelan’s case, she wasn’t told until 2017 that a review of her 2011 smear test had been carried out in 2014; by then she had received a terminal cancer diagnosis.

She settled her High Court action against the US laboratory involved in reviewing her smear test for €2.5million. Since then she’s been advocating for accountability and actions to be taken so this doesn’t happen again.

Speaking to the Public Accounts Committee  yesterday, she said:

I’m not interested in revenge, that’s not what I’m here for, I do want accountability.

“If I do die, I want it to be not in vain… I want people to be held accountable so that this will not happen again in any shape or form.”

Today, cases were brought in the High Court for two more women who have been affected by CervicalCheck screening issues.

The High Court ordered that the women not be identified – with the cases due to be heard in July, ahead of the summer recess of the courts.

What was new at this committee?

There were a number of new revelations teased out by committee members today.

Of the 209 women who were found to have had their smear tests incorrectly read, clinicians made the choice to tell their patients about the incorrect results in 40 of those cases (or around 20% of cases).

The committee also heard how other screening programmes share information with the National Cancer Registry. A controversy arose after it was discovered that some cervical cancer diagnoses weren’t logged with the CervicalCheck programme, but were with the National Cancer Registry.

This meant that the number of women affected by the smear test scandal could rise above 209 (the number of women with false negative smear tests registered with CervicalCheck).

The information sharing is conducted for the purpose of educational reviews, as is the case with CervicalCheck’s audits, which revealed Vicky Phelan’s false negative result.

The PAC heard that BreastCheck has a two-way information sharing system, which means that both share information with each other; that CervicalCheck has a one-way system, meaning that information is only shared by one organisation with the other (but not vice versa); and that BowelCheck has no information sharing system.

The committee was told that the BowelCheck programme, which began in 2010, was still too young for a comparative review.

The PAC is still hearing evidence, which can be watched here.

With reporting from Cormac Fitzgerald

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