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dc.contributor.authorHealth Service Executive (HSE)
dc.contributor.authorMacCraith, Brian
dc.descriptionBeginning on April 3rd, 2019, a woman, known as Sharon, sent a series of emails to the Department of Health (DoH) outlining her concerns regarding a significant delay in receiving results back from a smear test (taken on December 3rd 2018). Prior to this representation, Sharon had been in contact with CervicalCheck (CC) and, in her emails to the DoH, expressed her dissatisfaction with the response received, including the lack of clarity regarding the status of her results. As with other queries received regarding delays the DoH responded to Sharon on a number of occasions including by explaining the general situation regarding turnaround times for test results. On June 7th, in light of her further inquiries and the fact that she had not yet received her results as might have been anticipated at the stage based upon expected turnaround times, the DoH contacted the HSE’s National Screening Service (NSS) requesting individual patient level information to assist with their response to her. On June 25th, the NSS wrote to the DoH with information for a response to the representation made by Sharon. The letter stated that Sharon’s test had been processed, and reported on June 17th, but that "due to an IT issue in the laboratory”, Sharon was “not issued with a result letter from CervicalCheck”, although they did understand that her GP had received her result. The letter went on to state that they were “addressing this issue with the laboratory in question and are writing to all the women who have been affected”. Later on the same date (June 25th), the DoH contacted NSS by email, seeking clarification on the issue, its impact, if any, and how it had been resolved. The NSS provided a report on the matter to the DoH on July 10th). The report confirmed that the tests in question were HPV tests undertaken by a quality-assured Quest Diagnostics (QD) laboratory at Chantilly, Virginia, which the NSS agreed (in November 2018) could provide additional capacity for HPV testing in order “to assist Quest Diagnostics in processing an unprecedented increase in tests, caused by high demand for cervical screening in 2018, due to women’s understandable concerns during this period”. The report stated that the Chantilly laboratory was also used to re-test HPV (using a HPV DNA test) on a number of cervical screening samples on which HPV testing had been carried out initially outside of the manufacturer’s recommended timeframe of 30 days (the ‘Expiration issue’). The NSS report stated that the IT system used in Chantilly “required updates to ensure that it could generate result files that were compatible with CervicalCheck’s Cervical Screening Register (CSR) and thus ensure notifications were issued to GPs and results letters were issued to women”. The HSE became aware of the extent of this IT issue in June 2019, following their 5 investigations in response to queries arising from the representations made by Sharon to the DoH. In their July 10th report to the DoH, the NSS stated that IT updates had taken longer than anticipated to implement and outlined the following related impacts:  Results letters were not issued to approximately 800 women (number identified at that time)  A number (unspecified) of GPs did not receive hard-copy reports of results that the HSE had understood (from QD) to have been sent to the GPs. The HSE had already written to women to contact their respective GPs to receive these results. As a result of these issues emerging (followed by media coverage, beginning on RTE’s Six One News on July 11th), and particularly the concerns relating to how these matters were communicated to the women concerned, the CEO of the HSE Mr. Paul Reid announced on Monday, July 15th that he was commissioning an immediate and independent rapid review of the incident, to determine the facts that led to this situation and to identify how the communication of screening results to women and their GPs was planned and managed. The Terms of Reference (ToR) for the Review are 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 July 11th 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. I was pleased to accept the invitation of Mr Reid to conduct the review on an independent basis. The date for submission of the report to the Mr Reid was identified as Friday August 2nd, 2019. Professor Brian MacCraith, President, Dublin City Universityen_US
dc.publisherHealth Service Executive (HSE)en_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.titleIndependent Rapid Review of Specific Issues in the CervicalCheck Screening Programmeen_US

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