Screening service didn't know that lab outsourced its tests to Hawaii
CervicalCheck only found out weeks ago that hundreds of Irish women's smear tests were outsourced to Hawaii, Las Vegas and Florida.
The revelation was uncovered during the investigation of the CervicalCheck scandal by Dr Gabriel Scally.
The tests were sent to far-flung cities by the CPL lab in Austin, Texas, which was contracted to carry out cervical screening for CervicalCheck until 2013. Dr Scally is now to carry out a further probe to determine if this gave rise to safety issues.
Dr Scally said the outsourcing happened in 2010 after the Texas lab experienced a surge in tests.
Sonic Healthcare, which controls the lab, told the inquiry that there was "no breach of contract". Some 300 tests were sent to Orlando and 250 to Honolulu. The labs involved were fully accredited and of the "highest quality".
It acknowledged it should have informed CervicalCheck - but was unable to find evidence that it did because of the departure of key personnel.
Commenting on whether CervicalCheck should continue using the three labs which currently carry out screening in the United States and in Dublin, Dr Scally said he was satisfied there was "no reason" the existing contracts should not continue.
A new tender will be issued next year for labs to provide enhanced screening using a HPV test which should reduce the risk of errors.
"My scoping inquiry team has found no reason why the existing contracts for laboratory services should not continue until the new HPV regime is introduced.
"This new approach of HPV testing will significantly improve the accuracy of the screening process, increasing the chances of more cancers being prevented due to the detection of early changes."
Referring to the original decision to outsource testing to the United States in 2008, when CervicalCheck was set up, he said there appeared to be an over-emphasis on obtaining the lowest cost from suppliers without equivalent emphasis on other quality and service-level measures.
CervicalCheck has been over-reliant over the years on extending contracts and there was no evidence that attempts were made to test the wider market of labs since 2012.
The report found that a risk assessment conducted in 2012 put "false negative" test results at 18th in a list of 28 more severe risks to CervicalCheck.
It placed more emphasis on meeting targets for the percentage of eligible women availing of cervical screening.
He found that there was a "serious gap" in the arrangements for the proper governance of screening in general.
"There is a need for an expert body to support the Department of Health in the development of policy on both new and existing screening programmes," he said.
No quality assurance visits to laboratories used by CervicalCheck have taken place since 2014 and this is not in line with best practice. Visits should be done every three years.