HSE warned Donnelly off mandatory disclosure in cancer cases

Minister for Health Stephen Donnelly was warned by the board of the Health Service Executive that his plans to legislate for mandatory open disclosure in medical cases would have “negative consequences” for the State’s health screening services, it has emerged.

During three board meetings this year, HSE board members debated their concerns about amendments the Minister plans to make to the Patient Safety Bill that would make it a legal obligation for doctors and surgeons to disclose to a patient if a “discordance” was found in a look-back of their files.

News of the difference of opinion between the HSE and Mr Donnelly came on a day when Taoiseach Micheál Martin told the Dáil during tributes to CervicalCheck campaigner, Vicky Phelan, who died on Monday, that the mandatory disclosure legislation will be brought “to a conclusion before the end of the year”.

Speaking to the Oireachtas Health Committee earlier this year, Mr Donnelly said he believed “that the non-disclosure that happened in CervicalCheck, even though it does not neatly fit here, should still be legislated for”. It did not neatly fit, he explained, because some serious patient safety issues which result in death or serious harm are very clearly defined whereas a “discordance” found in previous tests for cancer “may or may not have been due to negligence”.

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“It might be just, unfortunately as we have all become painfully aware, due to the limitations of the system.”

However, Mr Donnelly said the Government was planning that “if we have an identified patient on an interval cancer where a look-back is done and a discordance has been found, regardless of whether that discordance subsequently happens to be a patient safety incident – it may or may not be – open disclosure is required under law”. He said he intended to provide full details of these plans in forthcoming amendments.

The amendments sparked concern within the HSE before and during the summer, with pushback to suggestions that interval cancers – where a cancer is found after a screening test - could represent a notifiable patient safety incident.

During a meeting of the organisation’s safety and quality committee in mid-April, officials were told “that inclusion of disclosure of interval cancer to the Bill could imply that interval cancers are patient safety incidents”.

“This is contrary to the three expert reference group interval cancer reports which outlined interval cancers as recognised, unavoidable, and expected occurrences in population screening programmes.”

A meeting of the HSE board then took place on May 27th where the chair “briefed the board on the proposed amendment to the Patient Safety Bill and the introduction of a notifiable incident directly related to cancer screening services at report stage”.

“The Board agreed that the chair should write to the Minister setting out the strong view of the Board that such an amendment would have negative consequences for the screening services.”

On July 27th it was noted that correspondence had been sent to Mr Donnelly “requesting that any such amendment in relation to interval cancers is not progressed”.

The debate about whether the cases highlighted by the CervicalCheck scandal are considered patient safety incidents comes after the Government was told in 2018 that Ms Phelan’s case was not considered to be a patient safety issue.

A redacted version of a briefing note about Ms Phelan’s High Court case sent to then minister for health Simon Harris on April 16th, said “The National Screening Service and Jerome Coffey, Head of the National Cancer Control Programme, have advised the Department in writing that they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test.”

The settlement of Ms Phelan’s court action later led to the revelation that more than 200 women diagnosed with cervical cancer had also received incorrect smear test results from CervicalCheck and that they had been kept in the dark about a screening programme audit showing that the tests had been incorrect.

In the Dáil on Tuesday, the Taoiseach committed to bringing the relevant amendments to the legislation forward to allow for mandatory disclosure.

“I want the legislation concluded by the end of the year, and we will work with might and main to make sure that happens,” he said.

Mr Martin also said there “have been many different perspectives among health professionals for a long time although many would support the duty of candour and the spirit and the idea in principle of candour in respect of full disclosure to patients”.

Questioned on Tuesday evening about its board’s statements, the HSE said: “We wrote to the Minister at the end of June 2022 and are continuing to engage with the Minister and the Department on aspects of the Patient Safety (Notifiable Patient Safety Incidents) Bill.”

A spokesman for Mr Donnelly said: “As the Minister stated at the Committee in March he intends to bring an amendment related to screening at report stage of the Bill. His position hasn’t changed.”