Dr. Adrienne Duff:

In respect of the matters of interest to the committee, our role is specific. It is the accreditation of medical testing laboratories to ISO 15189 and assessing procedural and technical standards to demonstrate competence to perform cytology screening. The scoping inquiry’s report identified a procedural lapse that occurred within the INAB accreditation process, specifically relating to MedLab, and I will elaborate on how this took place. MedLab was first accredited by INAB in 2011 for cytology screening following an assessment by an independent team of technical assessors, and this has been verified annually. The company’s principal location for this operation has always been based in Dublin. In November 2016, MedLab contacted INAB by email, proposing to hire a cytology screening employee - a cytoscreener - and to locate that person at its laboratory in Manchester. At the time, INAB considered the information, consulted technical assessors, and was of the opinion that the activities, monitoring and controls that were understood for the cytoscreening in Manchester would be in line with ISO 15189. INAB informed MedLab by reply email that, in principle, such a proposal potentially would be acceptable.

The matter of cytoscreening at the Manchester laboratory was not subsequently raised directly again by MedLab with INAB. The procedural lapse that arose within INAB is that we did not subsequently and formally follow through on this information. From November 2016 onwards, INAB continued its usual annual assessments of MedLab in Dublin, which confirmed continued compliance to ISO 15189 each year. During the assessments of cytology screening, the INAB technical assessor, a consultant histopathologist, assessed the competency records of all MedLab screening staff. The lead assessor assessed the laboratory management system and no major findings for cytology screening were raised during these assessments.

It is worth noting that MedLab employees who were subsequently confirmed as based in the Manchester site were included in the INAB annual assessment. However, their exact location was not readily apparent to the INAB assessment team from the records examined. Following INAB’s engagement with the scoping inquiry earlier this year, it became apparent that cytology screening at the Manchester site - referred to in MedLab’s email to INAB in November 2016 - was in fact fully operational. We now understand from the scoping inquiry’s report that MedLab began cytology screening in the Manchester site in February 2016. We immediately conducted a review within INAB in conjunction with our technical assessors. The main outcomes of this were as follows.

The competence of all relevant MedLab staff to perform cytology screening was assessed in detail by our technical assessors each year since 2016. The Manchester site was under the direct control and management of MedLab. The staff at the Manchester site were employed by and under the direct supervision of MedLab. The Manchester site was using identical documentation, work instructions, information technology and reporting mechanisms issued and controlled from the Dublin site. Employees in the Manchester site were included in the overall MedLab quality system and were monitored exactly as employees based in Ireland. On completion of this review and based on the evidence, INAB confirmed to the scoping inquiry that the cytoscreening conducted at the Manchester site was within the scope of the accreditation of MedLab.

We followed up this review with a specific on-site visit to Manchester in April 2019 as part of our annual surveillance visit to MedLab in Dublin. The review satisfied us that the cytoscreening at the Manchester site was accredited under ISO 15189 and the management system of the MedLab Dublin office.

However, for the avoidance of any doubt, we do not think it acceptable to have been unaware of or not formally notified of, the specific external location of some of MedLab Pathology Limited’s cytoscreeners in the Manchester laboratory. Our review determined that a more specific, direct and robust level of communication should have taken place between INAB and MedLab Pathology Limited at the outset. It is clearly our responsibility to ensure that all applicants for accreditation and accredited bodies keep us fully and clearly informed about proposals to modify or extend their accredited activities in order that these proposals can be scrutinised as fully as is necessary before being implemented. We immediately put in place procedures to rule out any further such occurrence arising. This includes scrutiny of the exact locations of any personnel within organisations seeking accreditation, implementation of new technology to track all such matters through our system, and checks and balances to monitor our own systems and staff.

In summary, it is the case that MedLab continues to meet the requirements of ISO 15189. It is also very important to emphasise that nothing in our review and assessments or in the scoping inquiry report, suggests that the quality of cytoscreening conducted at the Manchester site was of a lower standard to that conducted at the Dublin site. I will now hand back to Dr. McGuinness to conclude our comments.