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The addition of the Quest Diagnostics (QD) Chantilly Laboratory as a CervicalCheck (CC) Test facility took place “without proper operational due diligence, risk assessment of the downstream implementation and, therefore, risk mitigation”, according to a rapid review published examining the issue.
On 11 July 2019 HSE CEO Paul Reid commissioned Prof 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.
According to the review, which has now been published, “however well motivated, and although taken in the context of a major backlog of samples, the decision to proceed with Chantilly without first testing and validating that it could be seamlessly integrated into well established operating processes led to system failure with consequent impact on women and GPs.”
“The early introduction of ‘manual workarounds’ should have triggered serious concerns, proactive risk management and escalation. There was a gross underestimation of the scale and implications of the problem.”
The report states that while manual intervention for generating results reports “worked for most of the time”, there was a significant failure when a batch of approximately 800 results reports was not transmitted for printing and delivery in Ireland, due to human error.
“Throughout this review there was a constant theme of women frustrated by poor service and lack of information, their information,” according to the document.
“This was most evident in the decision not to communicate with women, whose samples were in Chantilly, about the IT problems and its implications for a full six months in 2019.”
The rapid review has made a series of recommendations.
The first of the recommendations states 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.
Also, a strengthened CervicalCheck needs to adopt a ‘Women First’ approach as a matter of priority, according to another recommendation.
“The HSE needs to ensure that QD delivers on its commitment to appoint a ‘Dedicated Project Manager’ for Ireland. A matching Programme Manager at CC [CervicalCheck] needs to be appointed as a matter of urgency,” the rapid review recommends.
Although the clinical risk is deemed to be low for the patients in the cohort covered by this review for complete assurance it is recommended more detailed evaluation of the referred history and subsequent findings should be carried out for this group
Also, 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,” according to the report.
In a statement, following the report’s publication, Mr Reid stated: 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.”