CervicalCheck: Gabriel Scally says ‘serious work’ needed to create open disclosure policy

The Government-appointed investigator into the CervicalCheck screening controversy said there was “unfinished business” and “serious work” to be done in creating a policy of open disclosure in Irish healthcare.

Dr Gabriel Scally made his remarks on publication of his report on the implementation of recommendations from his 2018 scoping inquiry into the issue. He said that very substantial progress had been made in implementing the recommendations but described open disclosure as a “process in the making” and that there was “much more work to be done.”

[ CervicalCheck: Hostility towards campaign group ‘completely unacceptable’, says Scally ]

The public health specialist said he was “astounded” there is a prohibition in law against people making a complaint to the HSE about a clinical judgment made by a doctor working for the health service.

Assessing the progress made in the implementation of his 50 recommendations, Dr Scally said he found it “very puzzling” that there was a prohibition under the 2004 Health Act against making a complaint to the HSE against a doctor or other healthcare professional providing care funded by the HSE.

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Dr Scally said he had “never come across” this before. He urged the Medical Council, the regulatory body for the medical profession, to change its approach to the concept of duty and culture of candour in dealings between doctors and patients.

He said that, “unfortunately”, the council had not changed the wording in medical guidelines which say that doctors “should” be open and honest with patients. “For me, that is the wrong way around - it should be ‘must,’” he said.

Dr Scally paid tribute to the late cervical cancer campaigner Vicky Phelan, who died earlier this month, saying that the “best way” of honouring the Kilkenny woman was to implement the recommendations in his scoping report, both in the letter and spirit of his recommendations. He said that Ms Phelan like so many others “caught up in the CervicalCheck debacle” wanted to see change.

“There have been very many tributes to Vicky over the last weeks since she died. I share the great sense of loss felt by so many,” he said.

[ Vicky Phelan ‘inspired not only ourselves but an entire nation’, say family ]

Dr Scally said the Government’s proposed legislation on creating a policy of open disclosure, the 2019 Patent Safety Bill, dealt only with a “narrow element of what is involved in open disclosure” around the “more serious end” of medical errors relating to the deaths of patients.

“It is a good thing to do that, but it should only be a first step,” he said.

It was his understanding, he said, that the bill “opens the way to increasing the range of errors where there will be mandatory open disclosure and I hope that that happens.”

In response to media questions, Dr Scally declined to comment on opposition within the HSE about the application of mandatory disclosure or its concerns about all smear test slides being disclosed to women because the request for a test review might be a notifiable patient safety incident.

“It is an important issue to get right,” he said.

He referred to previous watering down of legislation around civil liability for health service providers to final legislation that changed the wording from “shall make” at the bill stage to “may make” disclosures around patient safety in final legislation.

“It’s not a great way to make legislation,” he said.

Introducing his final report, Dr Scally told reporters that what was revealed in the aftermath of Ms Phelan’s case was that Ireland had a cervical screening programme that was “deeply flawed.”

It emerged that the cervical cytology slides of Irish women were sent to “far, distant laboratories abroad” that were “entirely unknown” to the CervicalCheck programme.

There was a quality assurance system within the HSE that was “not fit for purpose.”

Some doctors working for CervicalCheck communicated to women and families “the findings of an ill-designed audit in ways that were at times obstructive and callous.”

Some things said to women and families was “extraordinarily hurtful and damaging,” he said.

“It is, in my view, entirely reprehensive to claim in the past that CervicalCheck was as good as any other cervical screening programme in the world,” he said.

“If you can’t bring yourself to acknowledge past failings, why can anyone trust you today?”

Dr Scally welcomed the fact that a small cytology laboratory for CervicalCheck smear tests was being set up at the Coombe Hospital in Dublin but recommended setting up “an adequate back-up” and a “fail-safe mechanism” in light of the cyberattack on the HSE last year.

Minister for Health Stephen Donnelly asked Dr Scally last January to conduct a final progress report into the implementation of the 50 recommendations he made in his 2018 report.

Among them were the recommendation that a statutory duty of candour be placed both on healthcare professionals and the organisations they work for. He said this duty should also be extended to the individual professional-patient relationship.

He advised that the decision not to disclose an error or mishap to a patient must only be available in a “very limited number of well-defined and explicit circumstances, such as incapacity.”

‘Handled badly’

Each and every proposed decision not to disclose must be subject to external scrutiny and that this process “must involve a minimum of two independent patient advocates,” he said.

The CervicalCheck controversy surfaced in 2018 after Ms Phelan, who had cervical cancer, settled her High Court case for €2.5 million after she was given incorrect smear test results. Ms Phelan died earlier this month, eight years after her cancer diagnosis.

Within days of the settlement, it emerged that hundreds of women diagnosed with cervical cancer were not told about an audit of past smear tests. The HSE said at the time that in the cases of more than 200 women, the audit found on look-back that their screening tests “could have provided a different result or a warning of increased risk or evidence of developing cancer.”

The HSE said that, for these women, the tests could have “recommended earlier follow-up.”

[ Dr Gabriel Scally to review CervicalCheck programme revisions ]

The audit was undertaken after the women were diagnosed with cancer and was undertaken in direct response to their diagnoses after their cancers were notified to CervicalCheck.

Dr Scally criticised governance issues at the screening service and the way women were treated and how, if information about the audit had been available to consultants in 2016 and 2017, why the women were not informed. He found that of 204 women whose clinicians were told about the audit, some 161 were not told and, for 148 women, no reason was recorded for the non-disclosure.

The public health specialist said that the disclosure of the audit was “handled badly in most cases and sometimes very badly indeed.”

He found that one consultant told an affected woman: “What difference does it make?” when she asked why she wasn’t told about the audit.

Asked how she would be informed of further information, he told her: “Watch the news.”

“All health professionals should have a duty when things go wrong to deal in an open, honest and frank manner with the people affected and with the grace and compassion that they deserve,” said Dr Scally.

Mr Donnelly said he acknowledged Dr Scally’s concerns around open disclosure. The Minister said the Patient Safety Bill “provides a legislative framework for a number of important patient safety issues, including mandatory open disclosure.”

“Honesty and transparency are vital in healthcare and should be embedded in the culture of the health service,” he said.

“Patients and carers have the right to know when mistakes are made, what the consequences are, or may be, and what action has been taken not only to correct mistakes but to prevent similar occurrences in the future.”

Mr Donnelly said Dr Scally’s scoping inquiry will be looked back on “as a seminal moment in the history of Irish healthcare and will rightly be credited with improving the lives of generations of women in the future.”

In response to the publication of Dr Scally’s report, the HSE said the national screening service was beginning a new process from January under patient requested reviews for any individual with cervical cancer which incorporates full and open disclosure of all findings.

“We are committed to ensuring women who are informed about discordant results in the future will have a better experience of receiving this news than the women who received this information in the past,” the HSE said.

It said that the review process provides an alternative process for women to get answers and that it was designed based on feedback from members of the 221+ support group.

The HSE said that between 2008 and 2020 there were almost 3.2 million cervical screening tests provided and that 1,786 cancers were diagnosed in women who had come for screening.

Fiona Murphy, chief executive of the National Screening Service, said that it would fully consider Dr Scally’s final report and “ensure we implement its findings.”

Prof Noirin Russell, clinical director of CervicalCheck, said that it had worked with patients, including the 221+ group, who have “told us how we can improve on the previous audit process.”

“We are listening to patients and embedding the patient voice in our processes ensuring women can have trust and confidence in our service now and into the future,” she said.