Dr Gabriel Scally published his report into the CervicalCheck screening programme in September and is still engaged in finding out the truth. What were the main findings of his report and what lessons should be learned to stop such a tragedy happening again?
It made sorry reading – and even more tragic experience. Slides misread, abnormalities not picked up… 221+ women receiving incorrect smear test results. Nineteen women have already died. Most didn’t know that CervicalCheck had carried out internal audits that showed they had cancer but they hadn’t been told until whistleblower Vicky Phelan, a mother from Limerick, took a High Court case this April.
In May the country discovered that the results of the majority of the audits had not been sent on to the women involved, so they were unaware all that time that their cancer was progressing. Outrage – and fatalities – ensued.
What had gone wrong with the CervicalCheck screening programme? Why were the slides misread? Why wasn’t there more monitoring of the screening process? Why did such major mistakes happen?
Dublin mother of five, Emma Mhic Mhathuna was told her cancer was terminal in May. She sued the State and Quest laboratories to secure her children’s financial future and received a €7.5m settlement in June. She died on Sunday, 7 October.
Irene Teap was diagnosed with cancer in 2015 and died in 2017 after two undisclosed false tests. Her husband Stephen campaigned for an inquiry. Many more women chose not to go public about what they were or are going through.
National anger was compounded even further when it was reported that attempts were made to buy the silence of women who sought compensation from the State Claims Agency. Vicky Phelan didn’t sign any such clause. Instead she sued.
“They’ve fecked with the wrong woman this time,” she said in a memorable interview. “By God am I going to take these guys on!”
Dr Gabriel Scally was the man given the task of chairing a scoping inquiry into what happened with the CervicalCheck screening programme. He published his report on 12 September in order to bring clarity and find answers for the women affected – and for their families.
His work still continues and addressing the Oireachtas Health Committee on 20 October, he said that he still has many questions.
Dr Gabriel Scally
He wants more information around accreditation of laboratories, for example, and where and why slides were sent by a laboratory previously involved, and around why HSE tendering documents related to the labs that he needed to examine were shredded. He is still pursuing them...
Disturbingly, he is also not sure that the number of 221 women involved put forward by the HSE is correct. That’s because he has concerns around the protocols used to identify this original group. He believes the 18-month cut-off point used by the HSE between the original cervical smear test and the time a woman was diagnosed with cancer was flawed. No doubt there will be more truth digging to be done.
WHOLE SYSTEM FAILURE
So what did his scoping inquiry come up with in terms of answers about why this scandal happened?
It was a “whole system failure”, he said in his report. He found problems “everywhere he looked”. Not being told when the truth about their test results was uncovered was “felt very intensely”, he said.
In his 170-page report, Dr Scally examined 12,000 documents, visited the labs concerned and carried out hundreds of interviews.
“(Women affected) have expressed very clearly their anger at not being told at the time when the information from the audit became available and they are equally as angry about how they were eventually told,” he stated.
“It varied from unsatisfactory and inappropriate to damaging, hurtful and offensive.’
He particularly criticised the culture among senior doctors to “protect, deny and silence” and mentioned one upsetting case where a bereaved family who sought answers was told that “nuns don’t get cervical cancer”.
(Women affected) have expressed very clearly their anger at not being told at the time when the information from the audit became available and they are equally as angry about how they were eventually told
WHY THE SCREENING SYSTEM FAILED
These are the mistakes that led to tragedies:
Serious gaps in the governance structures and reporting lines between CervicalCheck, the National Screening Service and higher management structures in the HSE led to the system failing, he found. This confusion complicated the reporting of issues and multiplied the risks for women.Gaps in the range of expertise of professional and managerial staff directly engaged in the operation of CervicalCheck.Substantial weaknesses – and absences – of proper professional advisory structures. The current policy and practice in relation to open disclosure in the health service was “deeply contradictory and unsatisfactory”. No compelling requirement on clinicians to disclose – left up to their personal and professional judgment. WHAT IS NEEDED FROM NOW ON
There are three tasks that the State has to take on board to reassure women and their families affected by delayed diagnosis, the report states:
Ensure that the group of women affected and the relatives of the deceased are given the maximum amount of support in dealing with the difficulties that they face from these complex and distressing events.Implement the recommendations of this scoping inquiry.An independent review of implementation plans within three months and published progress reports at six-monthly intervals.WHAT THE SCALLY REPORT RECOMMENDED
Immediate ex-gratia payment of €2,000 to each woman involved or next of kin to the deceasedThat structured conversations be held with each of the women affected, or their families, who wish to have their story documented. A more comprehensive guide to the CervicalCheck screening programme be available online.That information statements be more explicit about why screening might miss abnormalitiesThat women should have full and open access to their cervical screening record on requestThat if there is a problem or error that open disclosure takes place in a “timely, considerate and accurate manner”.A system for compensating people harmed in screening and immunisation programmes should be established so that the need for people to enter into adversarial court proceeding would be removed. Addressing the Oireachtas Health Committee on 10 October, Dr Gabriel Scally said that we have come a long way to explain what went wrong but now the clinicians who failed to disclose information need to say sorry.
THE WAY FORWARD
However, Dr Scally believes that there is no reason why CervicalCheck should not deliver outstanding service for the women of Ireland if the following happens:
Significant change.Effective leadership.Improved clinical and public health medicine engagement.Powerful patient advocacy.Addressing the Oireachtas Health Committee on 10 October, Dr Gabriel Scally said that we have come a long way to explain what went wrong but now the clinicians who failed to disclose information need to say sorry.
He said that there was “collegiality in the medical profession that works for the good and at other times it is not helpful.”
He also encouraged Irish women to continue to have their smear tests.
“A good cervical cancer screening programme should pick up 75% of cancers,” he said.
The good news was that while confidence had been shaken in the screening programme, 80% of women were still availing of the screening. However, this is not enough, he said. “This means that 20% are at risk.”
It is as yet undecided whether or not there should be a full Commission of Investigation – something that Dr Scally thinks may not now be necessary.
The Institute of Obstetricians and Gynaecologists has called for open disclosure (when mistakes happen) by doctors but “this needs to be legislated for”, they said.
See www.scallyreview.ie for more information.
CervicalCheck patient support group launch
The formal launch of 221+ CervicalCheck patient support group took place on 14 October last in Farmleigh.
It has been established to support the women and families affected by the recent issues which have emerged in relation to CervicalCheck.
Carrie Smith, the recently appointed coordinator of the 221+ CervicalCheck support group, made a presentation on the rollout and function of the support group and the launch also included presentations from group members, Vicky Phelan, Stephen Teap and Lorraine Walsh, as well as representatives from the Irish Cancer Society, Marie Keating Foundation and Irish Patients Association.
Dr Gabriel Scally published his report into the CervicalCheck screening programme in September and is still engaged in finding out the truth. What were the main findings of his report and what lessons should be learned to stop such a tragedy happening again?
It made sorry reading – and even more tragic experience. Slides misread, abnormalities not picked up… 221+ women receiving incorrect smear test results. Nineteen women have already died. Most didn’t know that CervicalCheck had carried out internal audits that showed they had cancer but they hadn’t been told until whistleblower Vicky Phelan, a mother from Limerick, took a High Court case this April.
In May the country discovered that the results of the majority of the audits had not been sent on to the women involved, so they were unaware all that time that their cancer was progressing. Outrage – and fatalities – ensued.
What had gone wrong with the CervicalCheck screening programme? Why were the slides misread? Why wasn’t there more monitoring of the screening process? Why did such major mistakes happen?
Dublin mother of five, Emma Mhic Mhathuna was told her cancer was terminal in May. She sued the State and Quest laboratories to secure her children’s financial future and received a €7.5m settlement in June. She died on Sunday, 7 October.
Irene Teap was diagnosed with cancer in 2015 and died in 2017 after two undisclosed false tests. Her husband Stephen campaigned for an inquiry. Many more women chose not to go public about what they were or are going through.
National anger was compounded even further when it was reported that attempts were made to buy the silence of women who sought compensation from the State Claims Agency. Vicky Phelan didn’t sign any such clause. Instead she sued.
“They’ve fecked with the wrong woman this time,” she said in a memorable interview. “By God am I going to take these guys on!”
Dr Gabriel Scally was the man given the task of chairing a scoping inquiry into what happened with the CervicalCheck screening programme. He published his report on 12 September in order to bring clarity and find answers for the women affected – and for their families.
His work still continues and addressing the Oireachtas Health Committee on 20 October, he said that he still has many questions.
Dr Gabriel Scally
He wants more information around accreditation of laboratories, for example, and where and why slides were sent by a laboratory previously involved, and around why HSE tendering documents related to the labs that he needed to examine were shredded. He is still pursuing them...
Disturbingly, he is also not sure that the number of 221 women involved put forward by the HSE is correct. That’s because he has concerns around the protocols used to identify this original group. He believes the 18-month cut-off point used by the HSE between the original cervical smear test and the time a woman was diagnosed with cancer was flawed. No doubt there will be more truth digging to be done.
WHOLE SYSTEM FAILURE
So what did his scoping inquiry come up with in terms of answers about why this scandal happened?
It was a “whole system failure”, he said in his report. He found problems “everywhere he looked”. Not being told when the truth about their test results was uncovered was “felt very intensely”, he said.
In his 170-page report, Dr Scally examined 12,000 documents, visited the labs concerned and carried out hundreds of interviews.
“(Women affected) have expressed very clearly their anger at not being told at the time when the information from the audit became available and they are equally as angry about how they were eventually told,” he stated.
“It varied from unsatisfactory and inappropriate to damaging, hurtful and offensive.’
He particularly criticised the culture among senior doctors to “protect, deny and silence” and mentioned one upsetting case where a bereaved family who sought answers was told that “nuns don’t get cervical cancer”.
(Women affected) have expressed very clearly their anger at not being told at the time when the information from the audit became available and they are equally as angry about how they were eventually told
WHY THE SCREENING SYSTEM FAILED
These are the mistakes that led to tragedies:
Serious gaps in the governance structures and reporting lines between CervicalCheck, the National Screening Service and higher management structures in the HSE led to the system failing, he found. This confusion complicated the reporting of issues and multiplied the risks for women.Gaps in the range of expertise of professional and managerial staff directly engaged in the operation of CervicalCheck.Substantial weaknesses – and absences – of proper professional advisory structures. The current policy and practice in relation to open disclosure in the health service was “deeply contradictory and unsatisfactory”. No compelling requirement on clinicians to disclose – left up to their personal and professional judgment. WHAT IS NEEDED FROM NOW ON
There are three tasks that the State has to take on board to reassure women and their families affected by delayed diagnosis, the report states:
Ensure that the group of women affected and the relatives of the deceased are given the maximum amount of support in dealing with the difficulties that they face from these complex and distressing events.Implement the recommendations of this scoping inquiry.An independent review of implementation plans within three months and published progress reports at six-monthly intervals.WHAT THE SCALLY REPORT RECOMMENDED
Immediate ex-gratia payment of €2,000 to each woman involved or next of kin to the deceasedThat structured conversations be held with each of the women affected, or their families, who wish to have their story documented. A more comprehensive guide to the CervicalCheck screening programme be available online.That information statements be more explicit about why screening might miss abnormalitiesThat women should have full and open access to their cervical screening record on requestThat if there is a problem or error that open disclosure takes place in a “timely, considerate and accurate manner”.A system for compensating people harmed in screening and immunisation programmes should be established so that the need for people to enter into adversarial court proceeding would be removed. Addressing the Oireachtas Health Committee on 10 October, Dr Gabriel Scally said that we have come a long way to explain what went wrong but now the clinicians who failed to disclose information need to say sorry.
THE WAY FORWARD
However, Dr Scally believes that there is no reason why CervicalCheck should not deliver outstanding service for the women of Ireland if the following happens:
Significant change.Effective leadership.Improved clinical and public health medicine engagement.Powerful patient advocacy.Addressing the Oireachtas Health Committee on 10 October, Dr Gabriel Scally said that we have come a long way to explain what went wrong but now the clinicians who failed to disclose information need to say sorry.
He said that there was “collegiality in the medical profession that works for the good and at other times it is not helpful.”
He also encouraged Irish women to continue to have their smear tests.
“A good cervical cancer screening programme should pick up 75% of cancers,” he said.
The good news was that while confidence had been shaken in the screening programme, 80% of women were still availing of the screening. However, this is not enough, he said. “This means that 20% are at risk.”
It is as yet undecided whether or not there should be a full Commission of Investigation – something that Dr Scally thinks may not now be necessary.
The Institute of Obstetricians and Gynaecologists has called for open disclosure (when mistakes happen) by doctors but “this needs to be legislated for”, they said.
See www.scallyreview.ie for more information.
CervicalCheck patient support group launch
The formal launch of 221+ CervicalCheck patient support group took place on 14 October last in Farmleigh.
It has been established to support the women and families affected by the recent issues which have emerged in relation to CervicalCheck.
Carrie Smith, the recently appointed coordinator of the 221+ CervicalCheck support group, made a presentation on the rollout and function of the support group and the launch also included presentations from group members, Vicky Phelan, Stephen Teap and Lorraine Walsh, as well as representatives from the Irish Cancer Society, Marie Keating Foundation and Irish Patients Association.
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