Accreditation board unaware of lab’s existence until inquiry

The Irish National Accreditation Board (INAB) has defended its decision to retrospectively accredit a laboratory that it did not even know existed was operational for an extended period of time.

The INAB was criticised by Gabriel Scally in his supplementary report to the CervicalCheck scoping inquiry for accrediting the facility which he said did “not appear to have been considered actively by the accreditation assessors in 2016, 2017 or 2018”.

It emerged this week that Medlab Pathology Ltd in Sandyford, which was contracted to do CervicalCheck work, had set up a satellite operation in Salford, Manchester, to also read CervicalCheck smears, without the approval or knowledge of the national screening service.

Dr Scally said in his report that on the basis of information supplied to his inquiry, “it is clear that INAB considered that the cytology screening carried out in the Salford ancillary laboratory was automatically included in MedLab’s accreditation”.

I find this both surprising and disturbing, particularly given that INAB does not appear to have been conscious that this facility was operational.

He said if accreditation systems were to be relied upon “as one of the planks of safe laboratory services, it is important that the operation of those services is thorough, expert and credible”.

“The accreditation must also be specific about the facilities so accredited. It is stretching credibility that a laboratory facility can reasonably be accredited retrospectively for periods of time during which its existence was unknown to the accrediting body,” he said.

When the Irish Examiner asked the Department of Business, Innovation and Enterprise to clarify how the INAB could retrospectively accredit a facility, it said it had been informed by the Health and Safety Authority that while INAB was approached in 2016 by MedLab about the possibility of setting up an operation in Manchester, INAB “only became aware through the Scally inquiry process that Medlab had proceeded to set up this satellite operation in Manchester”.

The statement said: “However, it is important to stress that, even though the establishment of the MedLab operation in Manchester was not specifically surveyed by INAB in 2016, the accreditation standards being applied to the work of cytoscreeners in the Manchester laboratory were being reviewed by INAB in the context of its overall regular surveillance of MedLab’s Dublin facility.

This is because Medlab Dublin included the relevant data in material that it presented to INAB.

The statement said during the 2019 INAB surveillance visit of Medlab Pathology Ltd on April 17 and 18, 2019, it was confirmed that the laboratory continues to comply with INAB accreditation requirements.

The Salford facility was visited directly in April 2019 “and is now specifically identified in the accreditation details”.

The department said it should be noted that neither the Minister [Heather Humphreys] nor the Department has any supervisory or oversight role in relation to INAB’s accreditation activities.“INAB conducts its accreditation services independently of the Department,” the statement said.