The government privatised the cervical screening service, outsourced it to cheaper US labs, ran down the public provision of the service In Ireland and now tell us that failures to detect cancers in some women’s slides has nothing to do with outsourcing.
Since the Scally report, various Government Ministers and commentators have insisted the report shows there was no problem with the decision to privatise the service and outsource it to US labs since 2008.
They claim there is no evidence that US labs ran a poorer or cheaper service for Irish women than the Irish based public labs.
Here are the facts:
- US LABS WERE NOT ISO Accredited.**
Minister Harris and the HSE repeatedly told Deputy Brid Smith TD that all US labs had ISO accreditation. This is the international standard expected of medical laboratories. It turns out the US labs did not have that accreditation at all.
- US LABS STANDARDS ARE NOT THE SAME AS IRISH LABS
The US accreditation standard called CLIA, means a screener examining slides can look at up to 100 slides a day. In Ireland a screener would be expected to spend at least six minutes on each slide before making a decision, meaning the time spent on each woman’s slides would be much greater and that they would look at a maximum of 60 a day.
- SCALLY REPORT FOUND THAT THE PROCUREMENT PROCESS HAD “AN OVEREMPHASIS ON LOWER COSTS”.
Scally examined the procurement process from 2008 onwards, and stated that costs were “overemphasised” as criteria for selecting the winning bidder. US labs had lower costs and quicker turnarounds for tests results. The first contracts awarded 20% of the criteria for costs, while later contracts awarded 80% of the criteria to those Labs with lower costs.
Irish labs that tendered for the contracts in 2007 and 2008 scored highly in all areas, except cost. The US labs were cheaper.
- DOCUMENTS ON THE TENDERS AND CONTRACTS AWARDED UNDER THIS PROCESS WHERE DESTROYED IN 2017.
Scally found that “as a consequence some of the key material relating to the CervicalCheck tender competitions was not available to the Scoping Inquiry”
Therefore we can’t say why contracts were awarded to Labs that were not ISO accredited, with lower standards in screening and in the qualifications and expertise of screeners, or why Cervicalcheck continued to award contracts to CPL after site visits there found significant problems with them.
- ONE US LAB HAD SCREENERS WORKING PART TIME ON IRISH TESTS WHILE THEY WORKED ELSEWHERE ON NON-CYTOLOGY WORK.**
This makes it difficult to make sure the screeners were reaching the standards and targets expected of them. In Ireland, screeners are dedicated to cytology work and must examine a minimum number of slides per year to remain qualified to work in their laboratory. They are trained specifically for this work.
Each smear should be examined independently by two medical scientists specialising in cervical cytology with a clinical pathologist overseeing the results.
Screeners in Irish public labs will have taken a four year degree course, complete clinical laboratory placement training in all disciplines and then train for a year and half specifically on cervical cytology.
- SITE VISITS TO US LABS WERE INFREQUENT AND INADEQUATE.
Site visits should have made sure that the Labs were working at the standards required. In the ten years of the screening there were only 2 site visits to these US labs. There should be site visits at least every three years.
When the visit to CPL in Texas in 2011 found a number of problems with the service, Scally found that “no assurance was given by CPL on a number of standards” Despite this, Cervicalcheck awarded another contract to CLP in 2012
WHAT SCALLY DIDN’T TELL US:
Despite repeatedly asking Harris and the HSE, we have not been told where the 200 plus false negative slides came from.
Scally makes clear that the HSE and Minister could find this information out very easily.
Professional bodies representing pathologists and medical scientist have repeatedly said this information must be readily available.
But we still haven’t been told what Labs these false negatives came from.
The HSE know what labs are at the centre of this scandal but won’t reveal it.
They instead want us to believe that outsourcing and privatisation has nothing to do with this tragedy because that decision to outsource was taken by the Fianna Fail/ Green Government, and continued by Fine Gael/Labour and the present government.
Recent court cases in which US based Labs settled for multi- million awards suggest that the problem of false negatives that led to this tragedy comes overwhelmingly from US labs or their affiliates.
It’s time we put an end to privatisation and brought vital services back into public control.