You may be aware of the media coverage about delays to some women and their GPs receiving HPV retest results from Quest Diagnostics’ laboratories.
As a result of these issues emerging and particularly the concerns relating to how these matters were communicated to the women concerned, CEO, Paul Reid, has commissioned an immediate rapid review of this incident within CervicalCheck. The review will examine all aspects of this incident, with a particular focus on how these matters were communicated to the women using our service.

Paul Reid said today;
‘I have asked Professor Brian MacCraith, to act as independent external chairperson for this review, which I expect to be completed in a short number of weeks. Amongst the matters that will be considered will be how the communication process for providing results to women was planned and managed, and how this worked in practice.’

Background & context
On the 11th July 2019 it was reported in the media that the HSE and Cervical Check were responding to issues within the Cervical Screening programme. These issues related to one of Quest Diagnostics’ laboratories based at Chantilly in Virginia USA, who had delayed issuing cervical screening HPV retest results to some women and their GPs, due to IT problems that impacted on how result letters were electronically triggered.

Scope of the Review
The Review will examine the series of events within the Cervical Check programme that occurred following reported IT issues in Quest Diagnostics relating to the HPV test expiration for a number of women and the retesting process. The period of the Review will be from the time the IT issue first emerged, up to and including the public reporting of these issues on the 11th July 2019.
Areas to be covered by the Review
1. To determine the complete chronology of events from the time the IT issues first emerged up to the public reporting of these issues on the 11th July 2019.
2. To establish the agreed process for the communication of results to women and their GPs, how this was planned and managed and how this process worked in practice.
3. To determine the adequacy of the response put in place once these issues emerged and to determine where and what the learning is for the management and communication processes within and from the Screening Programmes.
4. To determine if the relevant procedures as set out in the HSE’s Incident Management Framework and Integrated Risk Management policy were followed and implemented.
5. To examine the appropriateness of the escalation and if, how and when the communication of the incident within the HSE’s governance structures and between the HSE and the Department of Health, and the relevant Cervical Check committee structures was managed.
6. To provide a report to the HSE’s CEO setting out the facts relating to the incident and to make recommendations for any appropriate further actions and future learning.
Leading the Review
The CEO as Commissioner of the Review has appointed an external expert, Professor Brian MacCraith, President of Dublin City University to undertake the Review.

Support for the Review
Professor MacCraith will be supported in his work by the HSE’s National Quality Assurance and Verification Team and will have access to any external expert advice he may require during the course of the Review.

Access to HSE personnel
Professor MacCraith will have access to any member of HSE staff where this is required to enable him to conduct the Review.

Reporting arrangements
Professor MacCraith will carry out his work independently and will provide a report to CEO, Paul Reid.
The Review will be carried out in line with the HSE’s Incident Management Framework.

Timeframe for completion of review
The Review Group will provide a report to the CEO by Friday 2nd August 2019.

Issues and risks identified during the Review
If during the course of the Review, Professor MacCraith identifies any immediate risks or safety concerns, he will escalate these to the HSE’s CEO.

HSE CEO, Paul Reid, added,
‘We have worked hard to try to rebuild confidence in the cervical screening programme in Ireland, and the delays identified in recent days in providing results to women are not acceptable. I want this work to commence quickly and be completed in a timely manner, and will ensure Brian and the team are aided in their work by the full cooperation of all involved in the HSE and in the National Screening Service.’

Biography of Prof Brian MacCraith:
Prof. Brian MacCraith is the President of Dublin City University (DCU).
Prof. MacCraith is a member of the Royal Irish Academy (RIA), a Fellow of the Institute of Physics, a Fellow of SPIE (the international Photonics Organisation), and a Fellow of the Irish Academy of Engineers. In 2014, he was awarded an Honorary Doctorate by the University of Massachusetts, Lowell. Prior to his appointment as President of DCU in July 2010, Prof. MacCraith was founding Director of the Biomedical Diagnostics Institute (BDI) a large-scale Research Centre focused on Point of Care Diagnostics. The BDI was established in 2005. Prof. MacCraith has chaired two important reviews on behalf of the Irish Government: the Strategic Review of Medical Training and Career Structures (‘MacCraith Report’ published in June 2014) and the Review of STEM Education in the Irish School System (Report published in November 2016). He chairs the Board of Trustees of Genio. He is a Board member of Social Entrepreneurs Ireland (SEI) and the Irish Business and Employers’ Confederation (IBEC).