A culture of “putting women first” will be developed by the HSE, as an immediate step, following the publication of the latest CervicalCheck report - a 74-page document into an IT error which led to more than 4,080 women failing to receive their result of a test for HPV.
For nearly 900 of them it meant their results were not issued to them, or their GP in many cases. For around 3,200 women, their doctors got the letters, but the women did not.
This matter was only made public on July 11, when a woman ‘Sharon’ contacted the Department of Health to find out about her delayed test results.
A major finding in today’s report was that the use of an additional lab in the US, Quest Diagnostics Chantilly Laboratory, to test Irish samples, did not undergo operational due diligence.
“The addition of the QD Chantilly Laboratory as a CervicalCheck test facility took place without proper operational due diligence, risk assessment of the downstream implementation and, therefore, risk mitigation,” reads today’s report.
This led to a “systems failure,” said Professor Brian MacCraith who was appointed to conduct the independent rapid review following Sharon making her story public last month.
He also found that there was a “constant theme of women frustrated by poor service and lack of information, their information.”
This was most evident in the decision not to communicate with women, whose samples were sent to Chantilly, about IT problems and its implications for a full six months.
Prof MacCraith said the fact women were not communicated to was "significant".
He also found that there are “too few people managing too many significant projects simultaneously".
There are currently 3,025 tests at risk of expiry while in a backlog after a delay in reporting results, the review also found.
Aside from the findings of the report and the development of a culture that puts women first, other steps will be made as a result of this rapid review.
The selection process for a new CEO for the Screening Programme (in line with an earlier CervicalCheck report) will now be commenced.
1. The HSE needs to move quickly to ensure that CervicalCheck becomes a well-structured, strongly-led organisation with good management practice and an active culture of risk management.
2. A strengthened CervicalCheck needs to adopt a ‘Women First’ approach as a matter of priority. This initiative will have a primary focus on the continuous flow of information to women, customer relationship management and trust-building measures. The feasibility of sample tracking at every stage of the process from woman to result should be pursued actively. Human resource needs to be dedicated solely to this ‘Women First’ approach.
3. The HSE needs to ensure that Quest Diagnostics delivers on its commitment to appoint a ‘Dedicated Project Manager’ for Ireland. A matching Programme Manager at CervicalCheck needs to be appointed as a matter of urgency. (This position is currently vacant).
4. All recruitment for a strengthened CervicalCheck needs to be given the highest priority and facilitated with an accelerated process.
5. In order to ensure the efficient implementation of these recommendations, it would be prudent to integrate them into the remit of the existing Oversight Group for Scally Report Implementation.
6. Although the clinical risk is deemed to be low for the patients in the cohort covered by this review, for complete assurance more detailed evaluation of the referred history and subsequent findings should be carried out for this cohort.
7. The HSE, with the support of Government, needs to accelerate progress towards the establishment of a National Laboratory for Cervical Testing, encompassing state of the art informatics, analytics and sample / result tracking. This will remove Ireland’s current high risk dependence on a single outsourced supplier.
8. The issue of recognising the important role of patient representatives should be addressed with a view to placing it on a more stable footing and enhancing relationships with all relevant elements of the healthcare system.
9. The HSE should appoint an International Advisory Group for CervicalCheck to ensure that it is adopting and implementing best international practice.
Updated with further information at 4:35pm.