The Minister for Health, Simon Harris TD, has today published the Supplementary Report of the Scoping Inquiry into the CervicalCheck Programme, following a Government decision earlier today. The Inquiry was led by Dr Gabriel Scally.
Following the publication on 12 September last of the Final Report of the Scoping Inquiry, Dr Scally committed to providing this supplementary report into certain further aspects of the laboratories, such as procurement, quality and accreditation arrangements, and governance structures.
The report identifies that the number of laboratories involved in CervicalCheck work was greater than originally thought. Crucially, however, it finds that, on the basis of the information available to the Inquiry, the use of additional laboratories did not result in a reduction of the quality of the screening provided to Irish women and there is no evidence to suggest deficiencies in screening quality in any laboratory. The Supplementary Report thus provides further welcome reassurance to Irish women about cervical screening quality.
Minister Harris said:
I welcome the publication of this Supplementary Report of the Scoping Inquiry into CervicalCheck and I thank Dr Scally and his team for the comprehensive work they have done. The Inquiry has identified that the number of laboratories involved in CervicalCheck work was greater than originally thought or, indeed, than was known to CervicalCheck. Dr Scally’s recommendations in this regard have been accepted by Government and will be implemented.
Crucially, however, Dr Scally is clear that use of the additional labs did not impact on the quality of the screening which was provided to Irish women and that the Inquiry has found no evidence to suggest deficiencies in screening quality in any lab. I hope that this will reassure Irish women that they can trust the results they receive from the CervicalCheck programme and that they should continue to attend for their scheduled screenings.
The Minister also welcomed Dr Scally’s acknowledgement in the report that substantial and important progress has been made to date in implementing the recommendations of his First and Final Reports. This progress is outlined in the Q1 Progress Report on Implementation of the Recommendations of the Scoping Inquiry, which is available on the website of the Department of Health.
Given the public health importance of a cervical screening programme that inspires trust and confidence by providing a world class service to the women of Ireland, Government’s focus will continue to be on working towards full implementation of all of Dr Scally’s recommendations
, he said.
Notes to the Editor
Supplementary Report of the Scoping Inquiry - Terms of Reference
Following the publication of the Report of the Scoping Inquiry into the CervicalCheck Screening Programme on 12 September, Dr Gabriel Scally committed to providing a supplementary report into certain further aspects of the laboratories, such as procurement, quality and accreditation arrangements, and governance structures. The Minister wrote to Dr Scally outlining the Terms of Reference for his supplementary report on 25 October and the Terms of Reference were published on the Department's website on 26 October as follows:
Further to the issues reported on by the Scoping Inquiry;
A. Examine further the facts and details of:
i) The additional laboratories involved in CervicalCheck work which came to light during the work of the Scoping Inquiry – their nature, ownership, extent of activity, quality and accreditation arrangements, governance structures, and other relevant matters;
ii) The circumstances which led to these laboratories undertaking work for CervicalCheck;
iii) The extent to which CervicalCheck / the NSS / the HSE were aware of, and approved, workload being transferred to other sites;
iv) The effectiveness and operation of procurement and contracting of laboratory-based cervical cytology services;
v) The use of Schedule 13 of the 2010 contract under the heading ‘Storage and Disaster Recovery Plan’;
vi) The respective and comparative merits and limitations of the standards achieved by each of the laboratories, and whether there is equivalence between the standards reached and ISO 15189;
vii) The intent and understanding of parties to the laboratory contracts in respect of ISO 15189.
B. Incorporate further relevant elements if identified during the the course of the supplementary analysis.
C. Consider the implications of the above issues for quality and safety.
D. Report to the Minister of Health on the matters above and making recommendations to address the issues arising.
These Terms of Reference, along with the previous reports of the Scoping Inquiry, can be found at the following link:
- The number of laboratories involved in CervicalCheck work was greater than was originally thought, 16 in total, and that the use of many of these laboratories was not approved in advance by CervicalCheck, nor was it known to it. Two additional recommendations are included in the report relating to contract specifications and quality assurance, which Government has accepted and which will be implemented along with Dr Scally’s existing recommendations.
- Nevertheless, and crucially, on the basis of the information available to the Inquiry, the use of these additional laboratories did not result in a reduction in the quality of the screening provided to Irish women and there is no evidence to suggest deficiencies in screening quality in any laboratory.
- The report references an important safeguard in screening in Ireland and Britain, which is that double reading of all Irish slides takes place, including on slides screened in the US, unlike the general US practice where slides are examined by a single screener.
- The two major accreditation standards in use (ISO and CAP) are comparable, and do not create any cause for concern in terms of the quality of laboratory services provided.
- A laboratory in Salford, UK, which is ancillary to and part of the main MedLab facility in Dublin, and which continues to provide screening for the Irish programme as part of MedLab, in Dr Scally’s view poses questions about governance and quality assurance arrangements. The performance data of this ancillary lab was included in that reviewed by the Inquiry in mid-2018, when it concluded that there was no reason, on quality grounds, why existing contracts for laboratory services should not continue. The Inquiry notes this lab has also been subject to a quality assurance visit by HSE staff. The provision of screening by this laboratory will be phased out at the earliest opportunity, noting that MedLab is now focused on clearing its backlog of slides, and all new slides being read by either Quest Diagnostics or the Coombe.
- Dr Scally expresses a view in the report that the system in place for responding to errors in screening is inadequate, and that public health programmes, such as screening and immunisation, would be suitable for the introduction of a No-Fault Compensation Scheme. The Minister for Health intends to consider this issue further once the Expert Group on Tort Reform has completed its work.
- Dr Scally acknowledges in the report the substantial and important progress to date in implementing the recommendations of his First and Final Reports.
Implementation of the recommendations of the Scoping Inquiry to date
The Final Report of Dr Gabriel Scally’s Scoping Inquiry into CervicalCheck was published on 12 September 2018 following Government approval. Government accepted all 50 recommendations made in the Final Report. The development of an Implementation Plan for all recommendations was overseen by the CervicalCheck Steering Committee, chaired by the Department of Health, which includes patient representatives and advocates, clinicians and senior officials from the Department and the HSE. The implementation plan includes a wide range of actions relating to progress of key legislation, including the HSE Governance Bill and the forthcoming Patient Safety Bill, the establishment of new bodies including an Independent Patient Safety Council and a National Screening Committee, the review of open disclosure policies and screening audit, improvements in cancer registration and engagement between women and families and medical bodies.
The Implementation Plan was first published on 11 December on the website of the Department of Health, following Government approval. Work has been underway across the health system since then on the range of actions within the Plan.
At the Minister’s request, Dr Scally undertook an independent review of the Implementation Plan for his recommendations. On 30 November 2018, Dr Scally wrote to the Minister with a preliminary positive assessment of the planning underway and of the commitment to making progress. Dr Scally also committed to providing his formal observations at a later date (his assessment is published here). These were received in February 2019 and incorporated into a revised Implementation Plan, which is available here.
The Implementation Plan contains 161 actions, which are being led, as appropriate, by the Department of Health, the HSE, the National Cancer Registry of Ireland and the 221+ Patient Support Group. The Department of Health has overall responsibility for overseeing the Plan. A summary Progress Report for Q12019 is available here. A detailed Q1 Progress Report, which shows progress action by action, is available here. The next Progress Report, for Q2 2019, will be published in July.
Recommendations of the Supplementary Report
The Report states that the 50 recommendations of the Final Report were comprehensive and remain valid. Two further recommendations are made:
- Future CervicalCheck contracts for the provision of cytology and other laboratory services should contain even more explicit provisions to ensure that no contracted cytology or other laboratory activity should be carried out anywhere other than in the precise locations, and by the precise company, identified in the written contract, without prior written permission from CervicalCheck.
This new recommendation is in addition to the seven recommendations of Dr Scally’s Final Report in relation to procurement, which are being implemented through 18 identified actions. Six of these were completed by the end of Q1 2019.
- The quality assurance (QA) process developed and operated by CervicalCheck must be based on a consistent and thorough approach to the quality of the laboratory services being provided to the cervical screening programme. This QA system must be designed and operated irrespective of the physical location of laboratories and the possession of external accreditation by the laboratory should not be viewed as in any way replacing or diminishing the need for CervicalCheck processes.
This recommendation is additional to recommendations relating to laboratory services and wider screening services included in the Final Report of the Scoping Inquiry. 36 actions in total were identified to implement those recommendations, seven of which were complete by the end of Q1 2019. This includes recruitment of a National Laboratory QA lead, and development of a project improvement plan for screening quality assurance programmes based on international best practice.
Actions to implement these additional recommendations will now be identified and incorporated into a revised Implementation Plan for all recommendations of the Scoping Inquiry, which will be published on the website of the Department of Health. Progress will be reported on quarterly, along with the existing recommendations.