The independent Rapid Review into CervicalCheck has found that a key feature of all samples sent to the laboratory at the centre of the IT problem was the delayed reporting of results.
On 15 July, CEO of the Health Service Executive Paul Reid announced that he was commissioning an immediate and independent rapid review of the incident.
The aim of the review was 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 review, carried out by Professor Brian MacCraith, has found the addition of the Quest Diagnostics Chantilly Laboratory as a CervicalCheck test facility "took place without proper operational due diligence, risk assessment of the downstream implementation and, therefore, risk mitigation".
The primary casualty was communications with the women and GPs, with the breakdown in automated results generation, it concluded.
There are nine recommendations from the review:
- 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.
- 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.
- 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).
- All recruitment for a strengthened CervicalCheck needs to be given the highest priority and facilitated with an accelerated process.
- 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.
- Although the clinical risk is deemed to be low for the patients in the cohort covered by this review (see section 6.4), for complete assurance more detailed evaluation of the referred history and subsequent findings should be carried out for this cohort.
- 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.
- 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.
- The HSE should appoint an International Advisory Group for CervicalCheck to ensure that it is adopting and implementing best international practice.