Tuesday 19 March 2019

Mis-read smear tests are sent back to same lab, reveals boss

Vicky Phelan with her family. Vicky was given incorrect smear test results in 2011
Vicky Phelan with her family. Vicky was given incorrect smear test results in 2011

CervicalCheck is sending smear tests for a "re-check" to the same laboratory where the mistake was made, the Herald has learned.

This self-audit procedure takes place after the screening service is notified that a woman who had an erroneous smear test through CervicalCheck has since developed cancer.

It raises new concerns about wider issues around the mistaken readings not being properly picked up.

John Gleeson, programme manager for CervicalCheck, confirmed that after it is notified a woman develops cancer, the original reporting laboratory involved in testing her smear is asked to retrieve her slide from the archive.

He said the laboratory "puts a team on it" to review the slide.

Victim Emma Mhic Mhathuna.
Victim Emma Mhic Mhathuna.

"If they see more than two grade changes of difference that is reported to us.


"If they say it is still the same as the original interpretation, then it is sent to an external laboratory to see if that can be confirmed.

"If there is a difference of opinion it goes to a second external laboratory to see the final interpretation on review of that slide, compared with the original," he told the Public Accounts Committee.

In some cases where they report a significant difference when comparing the original reading with the new analysis, that is sufficient.

The area of policing the three laboratories involved in doing tests for CervicalCheck will be part of the issues looked at by the scoping inquiry, which will have to determine if there is sufficient surveillance.

Mr Gleeson said laboratories have to be accredited to an international standard, which must be independently certified.

"That is the first thing, to be able to have and maintain registration. The second is that they must participate in external quality assurance schemes.

"These schemes, which are independent, receive a number of slides which they grade."

The slides are scored and the labs then "pass or fail".

They also return quarterly metrics of "detail and depth" about individual screeners and workloads.

"There is a lot in there and this is external quality assurance. We are constantly monitoring those and if they fall out of those, then we work to correct it immediately," he added.

Lab safety will be discussed at the Oireachtas health committee today.

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