Tuesday, 15 May 2018

Questions (381, 382)

Bríd Smith

Question:

381. Deputy Bríd Smith asked the Minister for Health the quality assurance site visits to laboratory providers since outsourcing in 2008 of the cervical screening programme. [20946/18]

View answer

Bríd Smith

Question:

382. Deputy Bríd Smith asked the Minister for Health the monitoring and reviews that took place of the operational activity and performance of the cytopathology service providers since 2010. [20947/18]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 381 and 382 together.

The clinical advice from the HSE and my Department is clear that there is no evidence that the clinical and technical aspects of CervicalCheckhave performed outside or below the quality guidelines set for the programme, or below international standards.

All laboratories contracted by CervicalCheck meet the programme’s standards and have ISO accreditation, certified by the relevant national authorities. The laboratories undergo annual certification or surveillance audits from the relevant national certification body for their continuing accreditation.

Monitoring and review of operational activity and performance of cytopathology service providers is carried out on a continuous basis. The laboratories provide quarterly quality metrics for monitoring and review. These include outcomes of the external quality

assurance schemes in which they are required to participate.

CervicalCheck monitors and reviews a number of criteria in relation to laboratory performance including volumes, sources of tests, turnaround times, recommendations assigned to results, screener sensitivity and workload metrics, external quality assurance and

positive predictive value.

CervicalCheck carried out site visits in 2011 and 2014 to the laboratory facilities involved in those years.