CervicalCheck Scandal and Open Disclosure
As a woman who has participated in the CervicalCheck programme and as a mother of two teenage daughters, I was shocked by Dr. Scally’s report. As a medical negligence lawyer, I was not.
For anyone who has not yet read the report, I recommend you do. It is a well written, no punches pulled report, containing throughout direct quotes from the many women affected by the CervicalCheck scandal and with whom Dr. Scally had met as part of his Scoping Inquiry. These quotes have been well publicised in the media and rightly so.
Dr. Scally recounts the experience of the family of a deceased woman who were told of the smear test audit:
“They said they went into their disclosure meeting and the consultant said several times about the late woman’s smoking habit and also told them that “nuns don’t get cervical cancer”. Now if that isn’t paternalism, what is? It’s verging on misogyny”.
He recounts another woman’s interaction with her Consultant as follows:
Woman: “Why didn’t you tell me? Why didn’t you tell my clinicians?”
Consultant: “What difference does it make?”
Woman: “How will I be informed from now on?”
Consultant: “Watch the news”.
Dr Scally’s report explains that cervical cancer can take a long time to progress from pre-invasive to invasive stage – up to ten to fifteen years. This means a test performed regularly, typically every three years will stand a good chance of detecting early signs.
He also explains that no screening test yet developed can deliver 100% sensitivity. For every thousand women screened, around twenty women will have pre-cancerous changes. The traditional cervical test (largely used by the CervicalCheck programme for the past ten years) will identify fifteen of the women and the HPV Test (the test that will now be used for the CervicalCheck programme) will identify eighteen of these women.
The CervicalCheck programme therefore, is an extremely valuable one to us women.
However, the following line in Dr. Scally’s report makes for stark reading:
“There was a period when women’s health was taken very seriously.”
The period Dr. Scally was referring to was 1997. Twenty-one years since our health was taken very seriously. Shocking indeed. What is also shocking is that since 2010, CervicalCheck, two years after it was set up, has not had a single accountable senior person responsible for the delivery of the programme on a full time basis. It was an accident waiting to happen.
Whilst Dr. Scally has found that all of the laboratories involved in the programme are meeting their regulatory requirements in their own country “and as far as can be ascertained, all of the laboratories have performance which is acceptable in their country” it was not of course within Dr. Scally’s remit to review the screening slides of the women affected by the CervicalCheck scandal. That task is presently being carried out by the Royal College of Obstetrics and Gynaecology. This makes me wonder if Dr. Scally has missed the big point. Sure, the criticisms he makes of the failures in quality assurance, management and governance of the CervicalCheck programme are well made and entirely merited, but there would be no issue whatsoever, if the slides were not wrongly interpreted by the laboratories in the first instance. Yet Dr. Scally has voted confidence in these laboratories. Indeed, we in Cantillons have instructed an independent expert to review and report on slides of clients we have managed to get from the HSE. This expert has in fact found that there was negligence in the reporting of those slides that he has reviewed to date.
For a number of our clients, records are still outstanding from the HSE since we first requested them in May 2018, since they were contacted by the HSE. Dr. Scally has said in this report “there can be no good reason for the delays in giving women access to their clinical notes”. We are now facing having to bring the HSE to court to compel the release of the records. So much for lessons being learned.
In respect of the auditing of cervical screening, Dr. Scally states that the principle of audit, in general terms, is to monitor the effectiveness of a health intervention, to identify areas of good practice and to make recommendations for improvements.
In respect of the CervicalCheck audit, he reports that the implementation of it has been difficult to follow. Throughout, there was minimal consultation with clinicians in designing the audit. Significant changes to the audit process were made at times. For example at the start, if results of review slides came back and there was a changed interpretation to a low grade abnormality, that was accepted. If, on the other hand, the review result was that there was a high grade abnormality, the slide was sent for external review. In 2013 the process followed was reversed. The first cases were logged in 2011 and the earliest case which underwent cytology review was sent to the laboratory in 2012. There were minimal instructions to the laboratories on how to undertake the review of slides. Governance of the audit was weak. Notes of a CervicalCheck Cancer Review Process meeting held on the 25th August 2015, revealed that over 1,000,000 women had been screened in the seven years since September 2008 and 1,067 cases of cervical cancers had come to the attention of CervicalCheck by March 2015. The internal team of three CervicalCheck staff reviewed each individual cervical cancer case and decided that of the 1,067 cases reported, a review was not appropriate in 767. (I am not entirely sure from Dr. Scally’s report how this decision came to be taken). Of the 300 that were to be reviewed, 234 required review of cytology (the microscopic review of cells), either alone or in combination with other aspects of the programme. There was a discussion at the time noting that actions to be taken in the event of abnormalities being missed had not been specified and there was a lack of certainty about whether this constituted an “incident”. This is relevant to the question of open disclosure referred to below.
Dr. Scally concludes that the CervicalCheck audit was established with laudable aims but planning, governance and documentation appear to have been inadequate. (My emphasis). There was little or no anticipation of the challenges which would arise when cytology (or other results) were reviewed. Participating laboratories were not given a specification of how to undertake cytology reviews and did not do so consistently. Analysis of the results was sporadic and informal.
Dr. Scally then considered CervicalCheck and open disclosure.
Open disclosure simply means telling the patient and/or next of kin the truth about an adverse event/incident.
This writer has long since been a strong advocate for making open disclosure mandatory. The HSE has had a national open disclosure policy since November 2013, but we here in Cantillons Solicitors have seen it ignored time and time again in our patients’ cases.
Dr. Scally is highly critical of the HSE policies and guidelines in respect of open disclosure. He notes that they are explicit in leaving a decision on whether to disclose or not to the unfettered judgments of the clinicians involved. Furthermore, if the doctor decides not to disclose the occurrence and details of an adverse event to a patient, that decision is not subject to any further scrutiny. He also notes that in the HSE/SCA guidelines for communicating with patients about adverse events there is a clause which states that non-disclosure may be appropriate if there is no evidence that the patient would benefit from such disclosure. He goes on to say that the overall message is contradictory. On the one hand, HSE policies support open disclosure and say it “must” happen; on the other it makes non-disclosure a distinct option.
This is the crux of the CervicalCheck scandal. Firstly, there was little knowledge in CervicalCheck of the policy of open disclosure. It seems it filtered down to CervicalCheck in 2014, possibly because a member of CervicalCheck staff was emailed a notice of a training event in 2014 on open disclosure in a local hospital and this only occurred because the person was formally on the staff of the hospital and was still on the hospital’s email distribution list several years later.
Ultimately a decision was made by CervicalCheck that open disclosure should apply to the audit findings in CervicalCheck and that it should be retrospective. It was decided that disclosure of the outcome of the review to the treating health professional would be the best option. We all know what happened next. Letters were dispatched to the treating clinicians with regards to 207 women and a game of pass the parcel ensued as to who would tell the women that their cancer had been missed. With 204 of those women the doctor notified was a hospital clinician. Of those 204 women, disclosure to the women or relatives occurred in 43 cases which represents one in five. Of those 43 women a record of the disclosure meeting was made in 42 incidences. An apology was given in 27 of the 43 cases and a record made of the apology in 6 of the 27 cases.
For the three women whose disclosure letter was sent to their GP, information is only available for two of them. Disclosure happened in one case, but there was no apology or record kept. No disclosure happened in the other case and no record was kept.
By any standard, this is proof that voluntary open disclosure does not work. The Taoiseach Leo Varadkar has denied in recent media reports that he and the Government performed a u-turn last year on whether to introduce mandatory open disclosure in the health service. In fact, this is not Leo Varadkar’s first u-turn. This writer highlighted a previous u-turn in an op-ed for the Irish Examiner on the 4th January 2016.
In a nutshell, if open disclosure had been made mandatory by Mr. Varadkar when he promised it, the CervicalCheck scandal would never have occurred.
On Saturday the 23rd September 2018, provisions governing voluntary open disclosure in the Civil Liability (Amendment) Act 2017 came into effect. According to the Department of Health website, the legislation is “designed to give legal protection for the information and apology make to a patient during open disclosure. The apology cannot be used in litigation against the provider. This approach is intended to create a positive voluntary climate to open disclosure”. (My emphasis).
I disagree. The reality is by making the apology protected, the Health Provider is protected from the consequences of their actions and an artificial screen is created around the apology so the patient may not rely on it. This does not create a positive voluntary climate for the patient, in my view.
The Patient Safety Bill which will make open disclosure mandatory has yet to be enacted. In its present format, it also provides that the apology, and indeed the information given to the patient, does not constitute an admission of liability or fault and is not admissible in litigation.
That is not an apology. That is a fudge. Yet another one.
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