A scandal in plain sight
An Oireachtas Committee meeting last week heard who knew what as some health chiefs passed the buck, writes Maeve Sheehan
Within 48 hours of terminally ill cancer patient Vicky Phelan settling the court action for her misread smear test, the clinical director of CervicalCheck cut short a trip abroad to come home and face the storm.
Professor Grainne Flannelly had been interviewed overseas via Skype the night before and the story goes that she went from the airport directly to RTE's radio studios the next morning to bat for the cervical screening programme that she has championed for years. She apologised and explained "best practice". But she fell at the killer question: there were 206 (now 209) women with cervical cancer whose abnormalities were missed when they were screened - did these women know? Dr Flannelly faltered. Pressed, she admitted that she could not say.
Her answer went to the heart of the crisis caused by the cancer audit scandal. We now know that 209 women with cervical cancer had missed scans. But CervicalCheck kept no central register of women who got false negative smears. In the frenzy of damage limitation, a Health Service Executive SWAT team spent last weekend pulling files and ringing doctors to ask them if had they had informed their patients.
This weekend it is clear that at least a dozen senior doctors, health managers in the HSE, and gynaecologists all around the country knew that women with cervical cancer were not being told their smears had been missed.
They knew because they argued for 15 months about who would tell these women. All the while, no one thought to ensure the women had indeed received the information they were entitled to. Some died during that period.
It was, in many ways, a scandal in plain sight.
At an Oireachtas Health Committee meeting last Thursday, Tony O'Brien, the director general of the Health Service Executive, and a panel of mostly male executives struggled to explain why they didn't see it.
The committee heard much important background; how CervicalCheck was set up in 2008 to screen women for cancer. When women developed cervical cancer, CervicalCheck had their slides reviewed in a cancer audit - but for educational purposes only. The women were not told - even if it turned out that their cancer was missed.
Then, in 2013, the Health Service Executive introduced a policy of open disclosure, promising honest and open communication to patients throughout their care, "especially when something goes wrong".
A year later, CervicalCheck decided women should be told of their audit results.
In 2015, CervicalCheck decided that women's "treating clinicians" should be the ones to tell the women. In 2016, CervicalCheck began sending the audit results to women's doctors with guidelines that advised that women should be told "as a general rule of thumb". But doctors should "use their judgment in selected cases where it is clear that discussion of the outcomes of the review could do more harm than good".
That was how the row began.
In July 2016, Vicky Phelan's audit results were sent to her consultant, Kevin Hickey. Vicky had been diagnosed and treated for cervical cancer by then, and in fact, was cancer- free. Her audit showed a squamous cell carcinoma had been missed. He believed it was not his place to tell his patient about a serious issue that had arisen on CervicalCheck's end.
By last summer, Kevin Hickey had informed Colette Cowen, the chief executive of UL group of hospitals, and Professor Paul Burke, chief clinical director, as well as the management of the local maternity hospital. He had also consulted with numerous gynaecologists around the country.
Dr Colm Henry, the national clinical advisor and programme lead for acute hospitals at the HSE, and Dr Peter McKenna, the former Master of the Rotunda and now head of the women and infants programme in the HSE, had also been informed.
The Sunday Independent understands that other senior figures in the HSE were also aware of the dispute that ultimately stopped 162 women with cancer from receiving the information they are entitled to. The HSE did not confirm this at the time of going to press.
Dr Henry received a letter on July 11 from Professor Paul Burke, the clinical director of the University Hospital Limerick, outlining the concerns of consultants over CervicalCheck's insistence that they pass on the audit results
After he got the letter, Dr Henry said he wrote to CervicalCheck and consulted another senior HSE official, Dr Peter McKenna.
Pressed by Stephen Donnelly, the Fianna Fail health spokesman, on what action he took on his "very serious breach of open disclosure", Dr Henry insisted he dealt with it.
Dr Henry said he was told there would be a meeting of clinicians on September 1 and, some days later, he said, he got a letter from CervicalCheck telling him agreement had been reached.
Dr Henry accepted the assurances and never followed up. "If I had known the patients were not going to be informed, I would not have been happy," he said.
Mr McKenna was similarly reassured. "I spoke to some of the clinicians and understood that a resolution as to who would inform the patient had been found at a meeting with the cytology service," he told the committee.
"I regret that I did not follow up to check on who that would be or, more importantly, that it was being done. I was led to believe that the matter had been resolved."
While consultants argued, Vicky Phelan was told for the first time by her consultant on September 17 that there had been a query around her original smear test.
Dr Kevin Hickey told her reluctantly: "It is because I feel the women deserve to know the results of the audit process, I have taken it on myself to go through the results of the audit with them as they return for their follow-up clinic," he had written to Dr Flannelly the previous month. Vicky Phelan had full-blown terminal cancer when she found out that squamous cell carcinoma was missed in her original smear test. If it hadn't been, she could have been treated much earlier and she might not be facing a death sentence.
When a letter from Vicky Phelan's solicitor landed on the desk of John Gleeson, programme manager at CervicalCheck, in January of this year, alarm bells didn't go off. The letter demanded disclosure of documents, Mr Gleeson told the committee, and letters like these don't always amount to anything either, he said.
When another letter landed on his desk in March, this time from the State Claims Agency, telling him a court date had been set for April, he was surprised at the speed of it.
Did the fact that a woman did not get disclosure set off alarm bells, asked Senator Colm Burke? Mr Gleeson corrected him: "The allegation was that the disclosure had been delayed, not that it had not been made."
His boss, Dr Jerome Coffey, the head of the National Cancer Control Programme, was also taken aback by the speed of the court case. Asked if he had reported the Vicky Phelan case up the chain, he replied: "It was happening day to day, it was that quick."
Vicky Phelan's case was against the HSE and the US laboratory, Clinical Pathology Laboratories. Attempts at mediation failed. The US lab had indemnified the HSE. John Gleeson told the committee that Vicky Phelan's legal team was asked to drop the case against the HSE, "and they said 'No'", said Mr Gleeson.
The legal team said it had an issue around the delay in informing the affected woman, he said.
"That element of the case was struck out; it was not that we did not tell the patient - it was noted that the information was late and took a long time."
Patrick Lynch, national director of Quality Assurance and Verification, who is heading the review, stressed that the HSE "objected" to the confidentiality clause that Vicky Phelan was being asked - but ultimately refused - to sign.
A briefing note on Vicky's case was prepared for Simon Harris, the Minister for Health, on April 16, but a few days passed before he read it.
Dr Tony Holohan, the chief medical officer, said they believed it was an isolated case: "The information we received gave us no reason to believe that there were concerns that went beyond the individual case. That has manifestly proved not to be the case and the public information that came out on the Thursday of that week made that very clear for everyone."
Tony O'Brien has acknowledged the abject failure of the HSE executives to spot the open disclosure scandal. The first he heard of Vicky Phelan's case was on an RTE news app - which made him "significantly unhappy".
CervicalCheck had missed the significance "of what was going on" and Mr O'Brien implied that he would have spotted the looming scandal, if only he had known about it.
Had the row been "escalated", he said, "we would clearly have intervened to make sure the objective, which was communication to patients, would have happened".
"It should have been escalated, if necessary, all the way to myself, although I would have hoped it would not have had to get that far. The fact that that escalation did not occur is a source of concern," he said.
Nevertheless, Mr O'Brien has refused to criticise his senior managers. They did what they could and were assured that an agreement had been reached in the dispute, he said. They were not accountable.
Mr O'Brien accepted that he was partially accountable: "As the head of the HSE, I must recognise that those who cocked up, to use the Taoiseach's phrase, were in the organisation but I did not personally make that cock-up so I cannot take full responsibility for it," he said.
Asked who should be made accountable, Mr O'Brien pointed the finger at CervicalCheck and doctors.
"Those who did not deliver the communication are accountable," he said. "Either the agreement was reached or it was not. If it was not, the person who told Dr Henry that it had been reached is at fault. If it was reached, the problem lies with the treating clinicians who were supposed to communicate the information but did not do so."
So the buck passed.
Expect more of the same by the time a non-statutory inquiry into the CervicalCheck controversy reports to the Government in June.