Harris needs to give assurance regarding Manchester Lab’s work and what actions HSE will now take

11 June 2019

Responding the second Scally Report, Labour Health spokesperson, Alan Kelly TD, has said there are serious questions to be answered by the HSE and the Department of Health.

Deputy Kelly said:

“Finally after a significant delay, we have been provided with the second report of Dr.Gabriel Scally’s inquiry into the Cervical Check controversy. This report due to be published in mid February but was subsequently delayed and was to look into the quality assurances in place regarding the laboratories being used by the Cervical Check Screening Programme. 

“Dr.Scally’s report has found that more outsourcing of smears took place than the HSE were previously made aware of. It is obviously worrying that women’s smears were being shipped off to labs that we did not know existed nine months ago.

“One startling piece of information is that one of these labs was not accredited while carrying out smear tests. This lab based in Manchester was not something Dr Scally was even aware of. Dr Scally himself has acknowledged in his report that the circumstances around the lab in Manchester are “surprising, and disturbing, in terms of the level of governance expected in a public health programme.”

“The lab carried out over 91,000 smears between 2016 and 2018, yet it had no accreditation to do so. It was visited by INAB on April 17th, this year, and it was retrospectively provided with accreditation. How can the HSE stand over a testing facility that analysed thousands of smears while not actually being accredited? Should INAB not have accredited this lab before this?

“While it is welcome that this lab is now finally accredited by INAB, it is baffling that smears were being analysed in a lab that was not accredited to Irish professional standards. When were INAB made aware of the Manchester lab and how?

“Can Minister Harris assure Irish women today that their smears which were carried out at a previously unaccredited lab were performed to accredited standards? Also we need to know how many smears were analysed at this lab while it was unaccredited between 2018 and 2019? Currently, we only have the figures for 2016 to 2018.

“There are serious questions arising from this report for the HSE. Questions as to the quality assurance programme of inspections that was in place? Who was carrying out such inspections? What records were kept? How contracts were negotiated with labs and made legally robust? Were contracts breached? How was procurement and tenders were carried out?

“Can the Minister now also ask the new CEO of the HSE what actions he is going to take as a result of this report? His predecessor committed to looking inwardly at performance of the HSE once Scally had concluded. This has now happened.

“The Department of Health also needs to account for why this report was delayed from mid February until now. The Secretary General of the Department told me in the Health Committee on Feb 13th that this report was imminent, that it would be out in days and now we have it four months later. Dr Scally was in Dublin and met with Minister Harris a day later on Feb 14th. I understand this report is now much more substantial than the report prepared in February and I welcome that but what changed on Feb 13/14th? 

“So what is the difference between what Scally was reporting in February and now? Would we have ever found out the detail we know now about the lack of quality assurances; the existence of more outsourcing to labs and the fact that the lab in Manchester which was unaccredited even existed if questions were not asked at that Health Committee meeting in February and Scally didn’t go and do a more substantial report?

“When reports like this are released, it is important to remember that there are real women at the centre of this scandal who have been impacted because of outsourcing who will probably never get total answers.

“We still need to do much more to restore confidence in this programme and make lives easier for women at the centre of the CervicalCheck controversy. We need proper clarity on quality assurance in the labs and timelines on when the backlog will be cleared’.


Note: See attached link to Oireachtas Health Committee meeting on 13/2/19 https://www.oireachtas.ie/en/debates/debate/joint_committee_on_health/2019-02-13/2/

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