Scally Review team to return to US to investigate smear test outsourcing

Members of the Scally Review team will return to the US shortly to try and establish how many smear samples were outsourced to laboratories with whom CervicalCheck had no contract.

However, Dr Karin Denton, a cytologist, cautioned that they would not be able do a full review as “some no longer exist”.

Dr Denton was addressing the Oireachtas Health Committee where concerns were raised around the behaviour of one of the laboratories contracted by the HSE to read the smears of women who take part in the national cervical cancer screening programme.

It emerged previously that one lab, CPL, had sent slides for examination to other labs — in Texas, Hawaii, and Florida. The HSE stopped using CPL in 2013.

Dr Gabriel Scally arriving at Leinster House ahead of the Oireachtas Health Committee hearing. Dr Scally is tasked with reviewing the implementation plan recommended in his report. Picture: Leah Farrell

Dr Scally informed the committee that as part of his continuing investigation into the laboratories, it had emerged the original tender documents were shredded “in an unusual exhibition of efficiency” by the HSE. HSE policy permits this shredding after 10 years have elapsed.

Dr Scally said they were looking at all laboratory contracting issues. The laboratories are currently in negotiation with the HSE about renewing their contracts which are due to expire imminently.

Dr Scally agreed with Labour TD Alan Kelly that CervicalCheck’s approach to quality assurance was more or less “non-existent”.

Mr Kelly pointed out that when work is outsourced, quality assurance inspections should be par for the course, yet the last such inspection had taken place in 2014.

Dr Denton outlined how HSE staff had travelled to a lab in Austin, Texas, in 2014 and had failed to notice that it was outsourcing smears to another lab which was not part of their contract.

“It wasn’t picked up,” she said.

She travelled to the laboratory herself and got “a partial answer — that they may have sent some smears to Florida and Honolulu”.

“It subsequently turned out they had the exact number. There is accurate data there, but sometimes it’s quite difficult to get,” she said.

Dr Scally said there had been a rumour that a laboratory in Mexico was used but it was more likely to be San Antonio which is close to the Mexican border.

Mr Kelly asked why no-one had drilled down into the lab errors that led to 221 women being told earlier smears were misread, potentially affecting the timing and type of intervention that could have benefited them.

He asked why no-one had gone into the laboratories to investigate the detail of individual cases.

“The laboratories appear to be statistically in line with international norms, but how do we know this is corroborated in each of the 221 cases?” he asked.

Sinn Féin health spokesperson Louise O’Reilly raised concerns in relation to the level of accreditation of the American laboratories which was not the level specified in contracts with the HSE.

She asked if it was “written down anywhere that anyone in the HSE thought the standards were equivalent”.

Dr Scally said: “I’ve seen no evidence anywhere that questions that should have been asked were asked.”

Mr Kelly questioned what the consequences were for stopping the audit process in CervicalCheck.

“How are we going to deal with the issue of slides now going out of date and the fact that women have to wait so long for smears?” he asked.

Dr Denton said at the moment the existing providers were unable to deal with the volume of smears which had resulted from additional uptake, that it was in excess of what they were contracted to do.

“This is resulting in backlogs... and those backlogs will continue to increase as long as the number of samples continues at the current levels. I think there is very little they can do to mitigate that because one thing they have learned is it’s not a good idea to send them off elsewhere.

“So I think this problem will continue,” she said.

Dr Denton said women due for routine smears were also getting stuck in the backlog “so it’s disproportionately affecting people due for a test, the ones we really want to engage in screening”, she said.

The Scally Review was set up to examine, inter alia, how 221 women with cervical cancer were not told smears were misread or that they were part of a HSE audit. It published its report last month and made 50 recommendations.

Dr Scally is tasked with independently reviewing the implementation plan recommended in his report. He met with Health Minister Simon Harris yesterday to discuss progress.

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