For Clinical Labs
In today’s diagnostic landscape, laboratories must deliver fast, reliable, and cost-effective results despite staffing shortages, tighter regulations, and rising technical complexity
Bedfordshire Hospitals NHS Foundation Trust navigated a major restructure within tight schedules
About Bedfordshire Hospitals NHS Foundation Trust lab
Bedfordshire Hospitals NHS Foundation Trust was established in April 2020 through the merger of Luton & Dunstable University Hospital and Bedford Hospital. This merger led to the integration of the pathology departments of both hospitals, forming a unified NHS pathology service across the two sites.
1 The objective
Large-scale analyzer replacement due to department restructure
The laboratory has been using Validation Manager for three years as their most important tool for the validation and verification of new assays and instruments. Previously, their verifications were very time-consuming and most of the statistics were done by clinical scientists, using informal Excel sheets and plug-ins. Data was spread over numerous files and involved transcription of values — an overall error-prone process. Validation Manager centralises data and works as a storage unit where all projects and data are securely stored and only accessible to relevant people.
In the past year, as part of the restructure, their biochemistry department went through a total replacement of their Roche modular analyzers with over 100 assays involved.
2 The solution
Streamlining over 100 verifications with Validation Manager
The analyzer replacement was only possible by using Validation Manager software, which allowed the laboratory to import data from analyzer result files and to replicate projects.
The timeframes were very tight; approximately 7 weeks for the first Roche line and then reduced to 3 weeks for the subsequent two lines. Each line had 3 modules: ISE, Chemistry and Immunology, involving over 100 tests. For each test, they did three types of studies including comparison and precision.
The entire process was completed by laboratory staff, only requiring approval from the clinical team, who had access to the studies and could monitor progress and add their notes and conclusions.
3 The result
Project completed against tight schedules
The three analyzer lines were verified within the required timeframes, thanks to the efficiency boost and the remarkable support provided by the Validation Manager team. The reports Validation Manager generates are standardised and of high quality, enabling faster clinical approval. Projects are now better managed and considerably easier to accomplish. Validation Manager also operates according to all regulatory and accreditation requirements. It is now used across all pathology services within the Trust.
