Revealed: 90,000 smear tests from Ireland were sent to a UK lab which was not accredited
More than 90,000 smear tests from women in Ireland were sent to a lab in the UK which had not been accredited and given an independent all clear.
The disclosure emerged in the second report of Dr Gabriel Scally today who said the lab operated by Med Lab in Dublin was in Salford in Manchester.
However, he said the lab was later accredited and he found no evidence of poor standards.
Dr Scally revealed that tests were outsourced to sixteen labs mostly around the United States without informing CervicalCheck.
He said he could find no evidence that there were deficiencies in the screening.
But the revelations were described as disturbing by CervicalCheck campaigner Lorraine Walsh and Stephen Teap today.
The report revealed:
- The number of laboratories involved in CervicalCheck work was greater than was originally thought, 16 in total, and that the use of many of these laboratories was not approved in advance by CervicalCheck, nor was it known to it. Two additional recommendations are included in the report relating to contract specifications and quality assurance, which Government has accepted and which will be implemented along with Dr Scally’s existing recommendations.
- Nevertheless, and crucially, on the basis of the information available to the Inquiry, the use of these additional laboratories did not result in a reduction in the quality of the screening provided to Irish women and there is no evidence to suggest deficiencies in screening quality in any laboratory.
- The report references an important safeguard in screening in Ireland and Britain, which is that double reading of all Irish slides takes place, including on slides screened in the US, unlike the general US practice where slides are examined by a single screener.
- The two major accreditation standards in use (ISO and CAP) are comparable, and do not create any cause for concern in terms of the quality of laboratory services provided.
- A laboratory in Salford, UK, which is ancillary to and part of the main MedLab facility in Dublin, and which continues to provide screening for the Irish programme as part of MedLab, in Dr Scally’s view poses questions about governance and quality assurance arrangements.
- The performance data of this ancillary lab was included in that reviewed by the Inquiry in mid-2018, when it concluded that there was no reason, on quality grounds, why existing contracts for laboratory services should not continue. The Inquiry notes this lab has also been subject to a quality assurance visit by HSE staff. The provision of screening by this laboratory will be phased out at the earliest opportunity, noting that MedLab is now focused on clearing its backlog of slides, and all new slides being read by either Quest Diagnostics or the Coombe.
- Dr Scally expresses a view in the report that the system in place for responding to errors in screening is inadequate, and that public health programmes, such as screening and immunisation, would be suitable for the introduction of a No-Fault Compensation Scheme. The Minister for Health intends to consider this issue further once the Expert Group on Tort Reform has completed its work.