The rapid review into IT issues in the CervicalCheck screening programme has uncovered "an absence of clear lines of authority and clarity of role responsibilities".
It has recommended that the HSE moves quickly to ensure that the programme becomes a "well-structured, strongly led organisation with good management practice and an active culture of risk management".
The review was commissioned by the HSE last month after it emerged that over 800 women who had undergone CervicalCheck screening were never issued with their results.
Prof Brian MacCraith, who is president of Dublin City University, was appointed as independent external chairperson. His completed review was published on August 6. It found that the number of women who had not received their smear test results was significantly higher than the 800 or so first suggested. The figure is over 4,000.
These results had been sent to the Quest Diagnostics (QD) Chantilly Laboratory in the US for testing. However, the report highlighted that the addition of this laboratory as a CervicalCheck test facility took place "without proper operational due diligence" and risk assessment.
"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...There was a gross underestimation of the scale and implications of the problem," the review stated.
It pointed out that when a system that is designed to be fully automated relies on a range of manual interventions over an extended period of time, as was the case here, "system failure is almost inevitable".
In this case, a decision was made not to tell women about the IT problem for six months.
Not surprisingly, women were very frustrated by the lack of information provided to them.
Meanwhile, the review also highlighted that within the screening programme, there are "too few people managing too many significant projects simultaneously".
"Senior staff in the National Screening Service (NSS) and CervicalCheck have essentially been dealing with rolling crises over the period encompassed by this review. It is very difficult, if not impossible, to effect operational best practice in that context, especially when human resources are very stretched and below optimal capacity," it stated.
The review makes a number of recommendations. It states that CervicalCheck needs to adopt a "women first" approach as a matter of priority, and that all recruitment for the screening programme "needs to be given the highest priority and facilitated with an accelerated process".
Speaking after the review's publication, HSE chief executive, Paul Reid, thanked Prof MacCraith for his work and said that the HSE "accepts entirely" his findings.
"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 organisationof CervicalCheck; developing a culture of putting women first; establishing a clinical evaluation and assessment of the women impacted; and establishing an audit of Quest's IT processes and interfaces," he said.
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