Nottingham Genomics and Molecular Medicine Service ISO 15189 UKAS Accreditation: Suspension
Dear Colleague
Following a recent unannounced UKAS assessment in January 2025, we are writing to inform you that the assessment team has recommended the suspension of the Nottingham Genomics and Molecular Medicine Service’s accreditation. This affects both accreditation numbers 8031 and 8044.
The UKAS assessment was triggered by incidents reported to UKAS by the Genomics service in December 2024 and additional information received from an external source.
The key finding from this assessment and cause for suspension included:
- Identification of gaps in the laboratory’s incident management and corrective action processes.
Positive improvements identified during the assessment included:
- Improved timely reporting of incidents to UKAS
- Evidence of good practice relating to the investigation of non-conformances
- Staffing levels had improved since the assessment in December 2024
This suspension is for a period of up to 6 months with a review, anticipated in April 2025. Reinstatement of accreditation is contingent upon a successful full follow-up assessment and the submission of evidence demonstrating improvement and implementation of findings raised at this assessment.
To ensure that the service can evidence the required improvements and continue to issue accurate results with sufficient resource to manage service and patient requirements, the following risk mitigation measures are planned:
- Review current procedures for timely management of Quality Management System activities.
- Work with other local Nottingham University Hospitals Pathology services and Wider East Genomics Laboratory Hub to learn from good practices.
- Update Quality Management System training to include changes to the ISO 15189:2022 standard.
- Additional business meetings with UKAS to support active schedule management.
We want to reassure you that despite this suspension, the Nottingham University Hospitals’ Genomics and Molecular Medicine Service will continue to provide a competent and accurate Cytogenetic and Molecular testing service. For further information regarding turnaround times please see Service turnaround times | East Genomics
If you have any specific concerns or queries relating to the content of this letter, please contact the laboratory directly.