A System Doomed To Fail At Some Point

The major cervical screening crisis emerged into the public domain because of a failed attempt to disclose the results of a retrospective audit to a large group of women who had, unfortunately, developed cervical cancer, Prof. Gabriel Scally told Health Minister, Simon Harris in his scoping inquiry report. Maureen Browne reports.

He said it emerged because of the extraordinary determination of Vicky Phelan not be silenced. But there were many indications that this was a system that was doomed to fail at some point. Screening services are sometimes finely balanced in terms of benefit and harm and could act as an early warning sign of wider systemic problems.

“Unlike many similar problems in healthcare delivery, and screening in particular, it was impossible to narrow the focus to a few or even a small number of areas. The problems uncovered are redolent of a whole-system failure. The recognition of the problem as a whole-system failure meant that the Scoping Inquiry had to delve into the full range of issues that have impinged upon the cervical screening programme and this increased the complexity of my task. But it has also placed me in a good position to identify the changes which are needed to renew and strengthen the screening service,” Prof. Scally told the Minister.

“The current policy and practice in relation to open disclosure is deeply contradictory and unsatisfactory. In essence, there is no compelling requirement on clinicians to disclose. It is left up to their personal and professional judgement. I know, very well, from very many of the women themselves and the families, that the issue of non-disclosure is felt very intensely. They 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. In my view, the manner in which they were eventually told of their situation in many cases varied from unsatisfactory and inappropriate, to damaging, hurtful and offensive.

“It is apparent that there are serious gaps in the governance structures of the screening services. In the specific case of CervicalCheck, there was a demonstrable deficit of clear governance and reporting lines between it, the National Screening Service and the higher management structures of the HSE. This confusion complicated the reporting of issues and multiplied the risks. It is clear that there are also serious gaps in the range of expertise of professional and managerial staff directly engaged in the operation of CervicalCheck. There are, in addition, substantial weaknesses, indeed absences, of proper professional advisory structures. These deficiencies played no little role in the serious issues that concern this Scoping Inquiry.”

Prof. Scally said he was satisfied with the quality management processes in the current laboratory sites i.e. CWIUH, Quest, and the Sonic Healthcare Laboratories, namely MLP and TDL. He was also satisfied that the quality management processes were adequate in the former provider, CPL in Austin, Texas, part of Sonic Healthcare.

He continued, “In August 2018, as a result of probing by the Scoping Inquiry, information was provided which indicated that slides from Ireland had been distributed by CPL to other laboratories to carry out at least part of the screening process. As detailed in the report, the Scoping Inquiry is now aware that slides were dealt with by laboratories in San Antonio and Victoria (both Texas), Honolulu (Hawaii), and Orlando (Florida). This information has only come to my attention in recent weeks. It clearly needs further and detailed examination, along with some closely associated issues of procurement and accreditation. I am happy to provide you with a supplementary report on these matters in due course.
But I want to be clear that CPL is not a current provider, and has not been since 2013, nor are any of the other laboratories to which they distributed slides. All of the laboratories visited by the Scoping Inquiry team are meeting the regulatory requirements current in their own country. There is abundant research evidence that screening sensitivity varies in different countries. As far as can be ascertained, all the laboratories have performance which is acceptable in their country.

“There are many dedicated and experienced staff working in the screening services, including in CervicalCheck. Their skills and expertise should not be lost. With significant system change, effective leadership, improved clinical and public health medicine engagement, plus new and powerful patient advocacy, there is no reason why CervicalCheck should not deliver an outstanding service for the women of Ireland.

“The continuation of cervical screening in the coming months is of crucial importance. My Scoping Inquiry team has found no reason why the existing contracts for laboratory services should not continue until the new HPV regime is introduced. This new approach of HPV testing will significantly improve the accuracy of the screening process, increasing the chances of more cancers being prevented due to the detection of early changes.”

In the specific case of CervicalCheck, there was a demonstrable deficit of clear governance and reporting lines between it, the National Screening Service and the higher management structures of the HSE.

Prof. Scally said the challenging but exciting prospect of turning cervical cancer into a rare disease in Ireland would require a strengthened focus and skilled leadership. The CervicalCheck programme must take full advantage of the new testing process by working more effectively to reach out to the 20% of Irish women who did not yet take advantage of cervical screening. This, plus the welcome extension of the ever developing HPV vaccine to boys, created a realistic prospect of the virtual elimination of cervical cancer in Ireland in the coming decades. This was a goal that he commended to the Minister.

He said public health programmes, like screening, vaccination, tobacco control or infectious disease surveillance, required a skilled and valued public health workforce. There was, unfortunately, limited public health medicine input into CervicalCheck and he firmly believed that was to its detriment. The time had surely come where public health physicians were accorded the same recognition as clinical colleagues and their skills deployed at the core of all public health programmes. He hoped that movement on this matter could take place in the near future.

He went on, “I am conscious that there are several important pieces of work taking place or in immediate prospect: The important task of Justice Meenan in making recommendations in relation to redress, the Royal College of Obstetrics and Gynaecology-led review of the screening slides, the commitment of the Acting Director General of the HSE to conduct an internal

investigation following the publication of this report, and the limited amount of additional investigation that you have asked me to carry out into the use of additional laboratories.

“Having considered the matter carefully, and reviewing the degree to which the Scoping Inquiry has managed to explore and clarify the key elements of the issues surrounding CervicalCheck, I have reached the view that a Commission of Investigation would not be the best way to proceed. In my personal view, there are two tasks that should now be given priority.

“One is ensuring 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 now face arising from these complex and distressing events.

there are many dedicated and experienced staff working in the screening services, including in CervicalCheck. Their skills and expertise should not be lost.

“The second key task is in implementing the recommendations of this Scoping Inquiry. I am impressed by how your Department is carrying forward the recommendations of my first report and has included representatives of the women and relatives at the centre of its activities. There is a danger that a prolonged investigation, whilst it might further elucidate the matters that I have considered and correct any inexactitudes in this report, would consume valuable energy and resources that would be better devoted to the implementation of recommendations and achieving progress.

“I would invite you to consider instead the commissioning of a review of progress, involving two specific elements:

• Within three months of the publication of the Scoping Inquiry report, there should be an independent review of implementation plans to be produced by each State body named in this report, in respect of the recommendations contained herein. The findings of this independent review of implementation plans should be submitted to the Minister and published.
• Thereafter, there should be a further review of progress reported to the Minister at six-monthly intervals and published.

“I would suggest that the women and relatives affected should play a prominent part in the oversight of these reviews.”

The scoping inquiry reviewed a total of 12,839 documents of which – 6,958 were provided by the Department of Health, 5,494 by the HSE, 380 by the State Claims Agency and five by the National Cancer Registry of Ireland .
Prof. Scally said there were significant and frustrating difficulties in the early stages of the Scoping Inquiry in respect of the timely receipt of all requested documentation in the appropriate format. Following a series of communications with the key stakeholder organisations, the Scoping Inquiry was given access to an electronic document management platform which was used both to supply key documentation to the Scoping Inquiry and to support the review and management of this documentation to enable the Scoping Inquiry to utilise the information within.