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:
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.
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;
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.
These Terms of Reference, along with the previous reports of the Scoping Inquiry, can be found at the following link:
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. These were received in February 2019 and incorporated into a revised Implementation Plan.
The HSE has committed resources and efforts to make a reality of a major goal of the report, which is to help build a stronger and more effective cervical screening service for the women of Ireland.Download
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. 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:
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.
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.