Wednesday 20 June 2018

Cancer service sends 're-check' tests back to lab that made error

Explanation: John Gleeson of CervicalCheck
Explanation: John Gleeson of CervicalCheck
Eilish O'Regan

Eilish O'Regan

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

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

It raises new concerns about deep-rooted issues around the mistaken reading potentially not being properly picked up.

The revelations come as it emerged CervicalCheck is due to carry out 49 more meetings about internal reports with the 209 women affected by the scandal and the relatives of those who died.

The HSE said 21 'initial meetings' have been held. Two women have yet to be traced.

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

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

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

"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 or otherwise.

"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 had to be accredited to an international standard so that 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 and return," he said.

The slides are scored and they "pass or fail".

Monitoring

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

"There is a lot in there and this is external quality assurance," he added.

"We are constantly monitoring those and if they fall out of those, then we go to work to correct it immediately."

The issue of safety in the labs used by CervicalCheck is to be discussed at the Oireachtas Health Committee today.

The programme currently uses three laboratories to process cervical screening: Quest Diagnostics Inc, Teterboro, New Jersey, USA; MedLab Pathology Ltd, Dublin; and Coombe Women and Infants' University Hospital, Dublin.

All three laboratories are certified by the relevant national authorities.

Meanwhile, CervicalCheck has received more than 20,000 calls to its helpline.

Irish Independent

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