HSE Statement: 6th August 2019
On July 11th 2019 the CEO of the HSE - Paul Reid - commissioned Professor Brian MacCraith to conduct an independent and rapid review of delays in issuing cervical screening HPV retest results to a large cohort of women and their General Practitioners.
These delays related to one of Quest Diagnostics’ laboratories based at Chantilly in Virginia USA. Professor MacCraith was asked to examine the series of events within the CervicalCheck programme that occurred following the delays. His terms of reference were as follows:
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 CervicalCheck 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.
Professor MacCraith presented his report to Paul Reid, CEO of the HSE, at 22:00 on Friday, August 2nd.
CEO of the HSE, Paul Reid said;
“Firstly, I want to thank those women, particularly Sharon, whose persistence ensured that this matter was brought into the public domain. Their determination will ensure that we have a better screening service in the future.While much work and many improvements have taken place in the CervicalCheck service over the past 15 months, it is unacceptable that women should have to wait so long for important information about their health.I want to thank Professor MacCraith and his team for their diligence in completing this important work in a timely fashion. Brian’s recommendations will allow the cervical screening programme to address the failings that led to these issues quickly and definitively.The HSE accepts entirely the findings of the MacCraith Review. The HSE commits to a careful and expeditious implementation in full of each of his recommendations. The HSE wishes to reiterate its apology to all of the women impacted by the delays in issuing important information to them.On foot of Professor McCraith’s report, I have set out a number of immediate actIons including; Strengthening the management, leadership and organisation of CervicalCheck; developing a culture of putting women first; establishing a clinical evaluation and assessment of the women impacted; establish an audit of Quest’s IT processes and interfaces.”
Note to Editors
The National Cervical Screening Programme has made an enormous contribution to the health of women in Ireland since 2008. Over 100,000 cases of cervical abnormality have been detected and treated since 2008, leading to a 7% year-on-year decrease in the incidence of invasive cervical cancer. Every second day a woman in Ireland is diagnosed with cervical cancer through the CervicalCheck programme.
1. Developing a culture of “Putting Women First”
- Engagement with patient reps and our recently established patient panel for screening
- Ensure the Patient and Public Partnership strategy currently being developed under Dr Scally’s action plan incorporates putting “women first”
- Consideration by interim CEO of National Screening Service (NSS), and recommendations to CEO of the HSE and HSE Board.
2. Strengthening the management leadership, organisation, resourcing and capability of CervicalCheck
- Commencing selection process for new CEO for Screening Programmes in line with Scally Report
- Immediate appointment of Ms Celine Fitzgerald as an Interim CEO (Transition process)*
- Conclude our Organisation Governance review of screening in Scally action plan
- Continue to implement the NSS recruitment plan filling key positions while mitigating the recruitment & retention challenges :
- Director of Public Health
- Cervical Check Programme Manager
- Enhanced CervicalCheck Laboratory resource
- Quality Assurance Resource
- Risk and Incident Management
- Quest Operations Manager
- Wider assessment of accountability framework in the HSE.
3. Completion of a ‘pathway review’ for women with changed results.
- HPV testing is performed as a triage of low-grade cytological abnormalities identified on smear tests
- This is aimed at reducing over-investigation and over-treatment of low-grade abnormalities
- Women who have low grade cytological abnormalities and whose tests are HPV negative return to routine screening scheduling
- Women who have low grade cytological abnormalities, and whose tests are HPV positive, are referred to colposcopy. These women are still considered low risk referrals
- With regard to the cohort of women whose result changed from HPV negative on RNA testing to positive on the more sensitive DNA testing, there are unlikely to have been any clinical consequences for them given that they come from a low-risk group
- To provide a greater assurance – for the group of 55 where there were discordant results (i.e. where the test changed from HPV negative on RNA test to HPV positive on DNA test), we will carry out a review of the pathway of this group to examine their history following referral for colposcopy and to establish the outcome of this referral. This review will take 4 weeks and all women concerned will be contacted at the outset, and following completion of the exercise.
4. Audit & Assessment of Quest Processes & IT Solutions (incl. traceability)
- Internal Audit to undertake an independent assessment of;
- Quest, system interface
- End to end processes and interoperability of systems
- Assessment of potential to develop an IT solution to provide women with access to their test progress and results that will improve access to information
5. Strengthen the balance between public and private providers
- Continue accelerated programme to develop a national cervical screening laboratory at the Coombe
- Agreement in place with the Coombe for the NSS laboratory to be developed at the Coombe
- Capital project design complete and accelerated construction plan developed
- Workforce plan being finalised for national laboratory and recruitment commenced
- Continue to strengthen the Quality Assurance work with Quest
- Review long term laboratory procurement strategy for HPV to ensure it considers Prof MacCraith recommendations.
6. Strengthen risk management processes and culture in the National Screening Service
- Ensure full implementation of the HSE’s Scally report action plan on risk management
- Complete organisational review of risk management structures across the HSE as part of Dr Scally’s action plan
- Increase the resources available to the recently appointed National Screening Quality & Risk Manager to strengthen implementation and compliance with risk management processes
- Work with the new CEO to strengthen the risk culture.
7. Align these recommendations with the Scally implementation Process
- Listening to the voices of women is a key feature of the recommendations from Dr Scally’s reports
- The HSE has developed 116 actions from Dr Scally’s Report – 74 of these are complete. Further actions will be developed to support implementation of Prof MacCraith’s recommendations – inclusive of timelines for their completion
- Implementation of recommendations from Prof MacCraith will be monitored & reported via the HSE oversight group chaired by Chief Clinical Officer
- To date, progress has been made in strengthening governance & management structures & processes across CervicalCheck, NSS & the wider HSE in addition to enhancements in the professional & public health expertise within the NSS
- An organisational & governance review has been completed for NSS – an alignment with recommendations from the Prof McCraith report will be undertaken
- The CCO has commissioned an organisational review of risk management structures across the HSE. The NSS has established a Quality, Safety & Risk Committee & appointed key personnel in risk and incident management roles
- The NSS has developed revised quality assurance arrangements to standardise quality assurance processes within CervicalCheck – these will be reviewed and aligned with recommendations from the Prof McCraith Report
- A procurement strategy for laboratory services to support introduction of HPV primary screening for CervicalCheck has been developed – this will be reviewed and aligned with recommendations from the Prof McCraith Report
* Celine Fitzgerald
Since 2012 Celine Fitzgerald has worked as a management consultant with a variety of clients as well as serving as a director on the Boards of the VHI and Ervia.
In 2016 she took on the role of CEO of GOAL at a time of particular challenge for the organisation, and led a successful transformation which has restored it as a key player in international development.
Ms Fitzgerald spent over 25 years in the telecommunications industry working in Eircom initially and subsequently moving to Vodafone. She served as a director of Vodafone up until her departure to take up the role of CEO at Rigney Dolphin, an Irish owned Business Process Outsourcing company.
Last updated on: 06 / 08 / 2019