Letters reveal how medics argued about disclosing error
Health Minister Simon Harris has come out firmly on the side of open disclosure, saying patients have a right to know of errors on their medical files.
He has appointed a hit team to examine suspicious cases that will report to Colm Henry, a senior director in the Health Service Executive.
New records show that for more than 15 months, debate about open disclosure for patients - and who should deliver that open disclosure - batted back and forth between Ireland's most senior clinicians. By last August, the row had escalated up the chain to Dr Henry, to whom Mr Harris's hit team will report.
Letters detailing some of the issues were released to Vicky Phelan's legal team for her court action.
They start on July 21, 2016, when CervicalCheck contacted her consultant gynaecologist, Kevin Hickey, to tell him that his patient's smear test had been reviewed, abnormalities had been detected, and left it up to Mr Hickey to tell Mrs Phelan "if open disclosure is indicated".
However, Mr Hickey believed this was not his responsibility. In a letter to Dr Grainne Flannelly, CervicalCheck's clinical director, he mentioned several "ladies" who were diagnosed with either invasive disease or in situ carcinoma, who were all "thankfully" alive and well, and undergoing follow-up.
"We feel it is inappropriate to contact them at this point to tell them that original smears have now been re-reported as showing different findings. We think this would only heighten their anxiety levels and not confer any advantage to them now in their clinical course, as they have all been managed appropriately," Mr Hickey wrote.
He told Dr Flannelly that it was the "responsibility of CervicalCheck to judge for themselves as to whether they have a responsibility to these ladies and acknowledge the alteration of their original smears after review".
Dr Flannelly replied on August 5, 2016, writing: "There is a balance in terms of communicating the results of an audit, particularly where women are unaware of its existence." This balance was "best judged by the clinician, who knows the patients and has been looking after the women".
The dispute rumbled on until June 2017, when Mr Hickey escalated the issue to the group chief executive of UL Hospitals Group and copied in a number of senior medical staff there. He complained that he had passed the women's files to Dr Flannelly and "requested her to deal with the matter as I felt it was the responsibility of the Cervical Screening Programme". But that did not turn out to be the case.
The following month, Dr Flannelly selected just three women from those charts whose smear tests had been audited for review who she felt should have "disclosure".
Mr Hickey wrote back: "There were other ladies where the review process has altered the original findings on the smear audit review and it looks from your notes that you have felt that these should be filed in the patient's notes and that no review is necessary. I just wanted to confirm that you are happy with this whole process centrally."
She replied by email on July 7, writing: "Yes - a balance needs to be struck in deciding who needs a formal communication of the outcome of the audit. The possibility of resultant harm is crucial."
Mr Hickey again challenged Dr Flannelly, pointing out one woman whose initial smear was "atypical squamous cells of unknown significance" which changed to a high-grade lesion in an audit review. "Could you further review the other cases to ensure there is not any other discrepancy that arises?"
Dr Flannelly replied that she was going on limited information. "Any discrepancies you point out only underscore the value of local decision making in this regard."
By August last year, Dr Henry, national director and clinical lead for acute hospitals, was informed of the dispute. He wrote to Dr Flannelly. She replied by outlining how CervicalCheck had "engaged" with the HSE's open disclosure and patient safety, and how the process of communicating the outcome of reviews was updated.
"If doubt exists that her disease might have otherwise been detected at an earlier time" or that she might have required more intensive treatment, it was her view that women should be made aware of this. The treating clinician was best placed to make that judgement call on "possible harm", she wrote.
The following month, Mr Hickey told Mrs Phelan about the audit. "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 wrote to Dr Flannelly in August 2017.