Irish women’s cervical cancer screening may now have to be outsourced to a laboratory in Sydney, Australia.
It follows revelations that slides have been sent from Ireland to US labs in Texas, New Jersey, Honolulu, Las Vegas, and Orlando, as well as to London, in recent years.
The testing is currently done in Medlab and the Coombe Hospital in Dublin. It is also outsourced to a lab in New Jersey, USA. However, the report by Dr Gabriel Scally reveals that Medlab, which is coping with a large volume of tests to process following the CervicalCheck scandal, may also have to send extra screening to be carried out at its lab in Sydney, Australia.
Dr Scally’s report said that Medlab and the HSE were in discussions on the matter.
The surge in the uptake of tests by thousands of worried women has put Medlab under pressure.
Women are now having to wait two months for the results of their tests.
Meanwhile, although Dr Scally has said that, based on his evidence, CervicalCheck can continue to use existing labs, he is to conduct a number of further investigations.
He is to examine further the standard of accreditation used by the labs in the United States.
Accreditation – which is essentially a certificate of high standards based on external inspection – differs in Ireland and the US.
Dr Scally discovered that the labs used by CervicalCheck in Texas up to 2013, and now in New Jersey, do not follow a system of accreditation known as ISO/CAP 15189, despite this being demanded in their tender contract.
Last May, Health Minister Simon Harris told People before Profit TD Bríd Smith in the Dáil that all the labs used by CervicalCheck have this form of accreditation.
“All labs contracted by CervicalCheck meet the programme’s standards and have ISO accreditation,” he said.
But this has now been found to be incorrect.
The US labs are compliant with their national form of accreditation as set out by the College of American Pathologists.
However, Dr Scally said that it would appear the accreditation system used in Ireland “may be at a higher standard” as it involves full-time assessors.
He is now going to carry out a comparative analysis of the systems.
The inadequate oversight by CervicalCheck of laboratories used for cancer screening has also emerged.
The five labs used at various stages since CervicalCheck was set up a decade ago were only each visited once by inspectors hired by CervicalCheck to get its own report, independent of regulators.
The last visit was in 2014, and no inspection has been made by CervicalCheck since.
The fact that one of the labs had in each of the five years between 2012 and 2016 picked up between twice and three times as many high grade changes in test readings was not properly probed.
The HSE said yesterday it is still in talks with labs about extending their services from October. Two are demanding to break free from an indemnity agreement.
Mr Harris said yesterday he will meet the Medical Council to discuss the disrespectful attitude of some doctors to several CervicalCheck victims and families.