Families want to know labs where mistakes were made: Stephen Teap on Scally Report

Families want to know labs where mistakes were made: Stephen Teap on Scally Report
Stephen Teap, Dr Gabriel Scally and Lorraine Walsh

Update 6.30pm: A second report by Dr Gabriel Scally into the testing controversy has found further outsourcing of slides, which neither the HSE nor the national cancer screening programme was aware of.

Dr Scally was originally informed of six laboratories when he began his scooping inquiry last May but it has since emerged that the number involved in CervicalCheck was 16 - two in Ireland, two in the UK, and 12 in the US.

The report states that there is no evidence to suggest deficiencies in screening quality in any of the laboratories.

However, Dr Scally says the system in place in Ireland for responding to errors in screening is inadequate to the task.

CervicalCheck campaigner Stephen Teap's wife, Irene, died of cancer after a test was misread.

He says families want to know the identity of labs where mistakes were made.

"I have Irene's result at home, it says Austin, Texas on it," said Mr Teap.

"As does every single other woman's results that got their slides done through CPL.

"But the problem is, we don't know where they were read.

"It's not going to be established by Dr Gabriel Scally because he hasn't been able to get that information.

I will be taking CPL to court. Can I get that answer when I'm in front of them? I will try.

Also speaking following the report was Lorraine Walsh of the 221+ cervical cancer support group and she said that today's report is concerning.

"We thought we had gotten all the labs last September and now to realise that there are 16 labs," said Ms Walsh.

"Gabriel has told us that the quality assurance systems were non-existent and if they were in place, very poor and I think if they were effectual quality assurance systems they would have known about the additional labs and we wouldn't be in the situation that we're in now."

Number of labs involved in CervicalCheck greater than originally thought

Update 5pm: A report examining the scale of outsourcing of smear tests by laboratories contracted to do the work by the HSE has been published.

Minister for Health Simon Harris published the Supplementary Report of the Scoping Inquiry into the CervicalCheck Programme following a government decision earlier today.

This supplementary report identifies that the number of laboratories involved in CervicalCheck work was greater than originally thought.

Families want to know labs where mistakes were made: Stephen Teap on Scally Report

Dr Scally was originally informed of six laboratories when he began his scooping inquiry last May but it has since emerged that the number involved in CervicalCheck was 16 - two in Ireland, two in the UK, and 12 in the US.

"It is profoundly disappointing that the Scoping Inquiry only learnt about the additional laboratories as a result of our extensive and intensive probing," said Dr Scally.

"There has been very limited evidence made available to the Scoping Inquiry to show that CervicalCheck was ever consulted actively and in writing about the potential or actual use of the 10 additional laboratories."

It also finds, on the basis of the information available to the Scoping Inquiry that the use of additional laboratories did not result in a reduction of the quality of the screening provided.

The report states that there is no evidence to suggest deficiencies in screening quality in any of the laboratories.

However, Dr Scally says the system in place in Ireland for responding to errors in screening is inadequate to the task.

"It is my view, based on the documentation and expert opinion available to the Scoping Inquiry, that the tendering process appeared to move over time to place an increasing emphasis on price rather than quality," he added.

The lack of transparency by the major private sector laboratory companies about the precise locations of their screening services provided to CervicalCheck, and therefore to Irish women, is entirely unsatisfactory.

Mr Harris welcomed the publication this afternoon and thanked Dr Scally for his work.

"The Inquiry has identified that the number of laboratories involved in CervicalCheck work was greater than originally thought or, indeed, than was known to CervicalCheck," said Mr Harris.

"Dr Scally’s recommendations in this regard have been accepted by Government and will be implemented.

"Crucially, however, Dr Scally is clear that use of the additional labs did not impact on the quality of the screening which was provided to Irish women and that the Inquiry has found no evidence to suggest deficiencies in screening quality in any lab.

"I hope that this will reassure Irish women that they can trust the results they receive from the CervicalCheck programme and that they should continue to attend for their scheduled screenings."

In the report, Dr Scally acknowledged that important progress had been made in implementing the recommendations of his First and Final Reports.

Mr Harris said that the Government will continue to work towards full implementation of all of the recommendations made by Dr Scally.

Families want to know labs where mistakes were made: Stephen Teap on Scally Report

The HSE has also welcomed the report saying that it provides further reassurance to Irish women about cervical screening quality.

Dr Lorraine Doherty, Clinical Director CervicalCheck reiterated the "crucial importance" of the continuation of cervical screening as mentioned by Dr Scally in the report.

"Like all screening tests, cervical screening is not perfect. Some women will still develop cervical cancer despite regular screening," said Dr Doherty.

"While the risk of cervical cancer can be reduced, it can't be eliminated by screening.

We recognise the many challenges faced by CervicalCheck and we are fully committed to addressing these and working to rebuild confidence in our screening programme.

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

In a statement released following the publication of the report, the HSE said: "we welcome Dr Scally’s view on the accreditation schemes used by laboratories, that there are no overall differences that may impact significantly on the quality of the final reports on cytology.

"Dr Scally has acknowledged in this report the substantial and important progress being made to date in implementing the recommendations of his First and Final Reports.

"Of Dr Scally’s 56 recommendations prior to today, including the 6 interim recommendations, the HSE has responsibility for implementing 32 and a further 8 recommendations which are jointly owned with the Department of Health.

Of the 154 actions against all of the recommendations, the HSE has responsibility for implementing 105 of them.

The HSE said that the following improvements have been made:

  • A National Laboratory Quality Assurance Lead has been appointed to Cervical Check – this is a new post that will provide significant expertise and assurance to monitoring quality of laboratory services in the programme. A Deputy Laboratory Coordinator has also been recruited to provide further support in the laboratory area.
  • A new pre-Quality Assurance inspection visit questionnaire was introduced to strengthen recent Quality Assurance visits in relation to additional capacity.
  • Quality assurance inspection visits to laboratory providers are in progress with a number already complete. All five of Quest Diagnostic’s laboratories have had an initial quality assurance visit, with a follow up planned in Q3.
  • Progress is continuing in relation to developing improvements in programme standards, quality assurance and the implementation of a single agreed terminology for recording results at the next Clinical Advisory Group.
  • The National Screening Service has developed, tested and validated the cervical screening report specifications in order to obtain comparable data excluding samples taken from colposcopy and will publish all performance statistics on samples taken in primary care or equivalent.
  • Updated standards for laboratories will also be implemented in line with the introduction of HPV primary screening.
  • National Screening Service has collated data for the next annual report (for 2018) on all categories broken down by providers. A review of the data is currently taking place prior to its publication.
  • The newly appointed Director of Public Health in the National Screening Service is establishing a quality improvement project across all programmes in order to adopt a formal quality assurance risk management approach.
  • You can read the full report below:

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