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Relief rather than surprise was my dominant feeling after reading the new Scally report
“Nothing would surprise me,” Dr Gabriel Scally said, “I’m absolutely amazed at some of the things that I’ve found.”
In forthright language, Dr Scally explained that both Quest Diagnostics and CPL/MedLab had outsourced slides from Irish women, without informing the HSE. So far, 16 laboratories have been identified, some “terribly small”. In the case of Quest, the team had to ask “direct questions” at a “face-to-face” meeting in January to find out.
I wasn’t surprised. I was relieved. When the first Scally report was launched, I found it odd that non-disclosure took up so much airtime. This report puts the focus back on labs and lab quality. After all, the cases of Vicky Phelan and the late Emma Mhic Mhathúna were settled for large sums because of serious lab errors.
Ten years ago, there was shock when a US corporation, Quest Diagnostics, won the tender for the national screening programme. The Minister for Health at the time Mary Harney said that the price was “one-third” of the price of some Irish labs. I thought that was bizarre – how could it be so cheap?
Since the first Scally report, they’ve been marginalised by the constant message that screening saves lives, and ‘false negatives’ are an unfortunate part of the programme
A friend working in quality control said it would be a difficult contract: The volumes were large and varying and the turnaround time was very tight. She said the lab would definitely outsource, unless forbidden by the contract. After that, the only question for me was where the smears were outsourced to.
I’m sure the affected women and their families are shocked, but perhaps they’re a little relieved also. Since the first Scally Report, they’ve been marginalised by the constant message that screening saves lives, and “false negatives” are an unfortunate part of the programme.
But on RTÉ, Dr Scally confirmed that we won’t know if there are quality issues until the slides are reviewed, in the UK, by the Royal College of Obstetricians and Gynaecologists (RCOG). Yes, all 16 labs were accredited in their own countries, but that does not guarantee a quality outcome.
These issues were not articulated clearly after the first Scally report. Instead the focus was on non-disclosure. Remember, the doctors didn’t tell their patients that CervicalCheck did an audit and found the laboratories had made mistakes.
The RCOG review will help to distinguish false negatives from avoidable error. We’ll finally have a “heatmap” of the severity of errors and which of the 16 labs they came from. Dr Scally was not asked to do this.
In the meantime, CervicalCheck don’t seem to have a record of their audit. The US laboratories don’t issue revised reports when an error is found. The only evidence comes from harrowing court cases. Oddly enough, the person who knows the most right now is Cian O’Carroll, solicitor for many of the affected women, because he sees the expert reports on individual cases.
Like Dr Scally, I’m also amazed – I’m in the report! Footnote 5 references my November 2018 Medical Independent article, ‘The time for restraint is now over’, which mentions that I wrote to Dr Scally. Last December, I met with a member of his team and we had a wide-ranging discussion, about laboratory outsourcing, but also about Ireland in 2008.
We’re in a different era now, because the entire economy was brought down by private sector banks. Back then, the message was ‘private is better than public’. Minister Harney welcomed US corporations into Irish healthcare. Co-located private hospitals were planned for public hospital sites. There was concern that the NIMIS computer system could be used to outsource radiology reporting to the US or India. Quest Diagnostics was a possible candidate to run ‘cold’ laboratories, outsourced from public hospitals.
It was a time when health professionals were dismissed as ‘vested interests’. Doctors were not needed for the design of the tender for Irish cervical smears because accreditation was proof of quality.
I went back to the Dáil debate of 29 May 2008. Quest had won the tender, but the contract was not yet signed. Many TDs were worried.
Jan O’Sullivan wondered if the short turnaround time was chosen “to specifically exclude Irish labs”. Former Health Minister James Reilly said that accreditation “is not a guarantee of quality outcomes”. Emmet Stagg, a former lab scientist, referred to the diagnostic problems with slides sent to Quest in 2007, from the Mid-West. He warned of “a decreased accuracy in the pick-up rate for high grade smears”. And Michael D Higgins referred to “a murky level of corporate ethics”.
Minister Harney repeated that the price from Quest was “one-third” of the Irish labs. And so the high quality cytology service in Ireland was wiped out.
Screening saves lives. Better screening by better laboratories saves more lives.
When the RCOG review is done, an apology may need to be made for how the State was blinded by shiny US corporations. That apology would be to Vicky, Stephen, Lorraine, the family of Emma Mhic Mhathúna and to the women of Ireland.