LAST UPDATE | 12 Jun 2019

TAOISEACH LEO VARADKAR has criticised the outsourcing of Irish cervical smear tests to other labs, saying that it might be “a breach of contract”.

Yesterday, Dr Gabriel Scally released his second report in response to the CervicalCheck inquiry, and found that the number of laboratories examining cervical smears was 16.

When he first began the Scoping Inquiry in 2018, he was told that there were six labs involved in Cervical Check screening; it’s understood that the National Cancer Screening Service were unaware that the laboratories were outsourcing smears.

In one case, a laboratory in Salford was granted retrospective accreditation by the irish National Accreditation Board (INAB).

HSE reaction

The HSE said that while it recognises Dr Scally’s concerns in relation to the accreditation of MedLab Pathology’s Salford facility, it noted that he confirms that “ …on the basis of the information available to the Scoping Inquiry, the use of these additional laboratories did not in fact result in a reduction in the quality of the screening provided to Irish women and it is important to acknowledge this”.

The HSE said this concurs with its ongoing performance monitoring in regard to Medlab Pathology. 

“The performance of MedLab, including the Salford facility, has always been within acceptable standards for cytology. Since we were made aware, in October 2018, of the existence of the Salford facility, we have reviewed the data from this laboratory separately and, over the last two quarters, have found that it remains within acceptable standards,” the HSE said in its statement today. 

Dr Lorraine Doherty, Clinical Director CervicalCheck said: “We welcome that Dr Scally has upheld the quality of cervical screening in Ireland, notwithstanding the issues raised in relation to the use of additional laboratories.”

Dr Doherty said CervicalCheck is “fully committed to implementing Dr Scally’s recommendations and rebuilding confidence” in its screening programme.

“We are committed to delivering the best possible cervical screening service for the people in our care and their families,” she said. 

‘Unacceptable’

Speaking in the Dáil today, Varadkar said that “the revelations that some of the labs outsourced slides to other labs is serious, it is unacceptable, it wasn’t approved and it may well have been a breach of contract”.

It shouldn’t have happened and it should have been picked up by CervicalCheck’s own quality assurance and management scheme and clearly was not.

“I do think it is reassuring however that the labs were accredited, albeit one retrospectively, and that Dr Scally says that there no reason to believe that the labs were sub standards in any way.”

In terms of the 105 actions assigned to the HSE, 42 have been completed, 52 are in progress and 7 due to start later in 2019. Most actions will be completely implemented by the end of 2019, the HSE said.

“Further recommendations arising from this supplementary report will be progressed similarly. This will hopefully over time help restore women’s confidence in our cervical screening programme, which plays a key role in reducing cervical cancer in Ireland,” the HSE’s statement said.

Although governance and disclosure issues with the CervicalCheck programme have been highlighted in recent years, medical professionals and advocates including Vicky Phelan have been eager to highlight the importance of the screening programme, and have repeatedly said that it does save lives.

The screening programme offers a free cervical smear test to women aged between 25 and 60 every three to five years (depending on age and other factors).

The waiting list for results to these tests have been dramatically delayed in recent months after the Minister for Health Simon Harris announced extra, or out-of-cycle free repeat smears in the wake of CervicalCheck controversy in order to restore public confidence.

The waiting time has increased from 2-4 weeks, or a maximum of 6 weeks, to up to 30 weeks at the height of the backlog. Harris has said that he expects the backlog to reduce significantly by the summertime. 

- with reporting by Rónán Duffy and Hayley Halpin