ORGANIZATION TYPE
Medical laboratory
How Sørlandet Hospital accelerates instrument implementation with Validation Manager
Read their story
LOCATION
Norway (Arendal, Kristiansand, Flekkefjord)
DEPARTMENTS
Medical biochemistry, Biomedical chemistry
PRODUCT USED
Validation Manager
About
Sørlandet laboratory operates across three hospitals: Arendal, Flekkefjord, and Kristiansand. Each location has its own lab, covering various fields of medical science, including medical biochemistry, blood banking, microbiology, and pathology.
About
Sørlandet laboratory operates across three hospitals: Arendal, Flekkefjord, and Kristiansand. Each location has its own lab, covering various fields of medical science, including medical biochemistry, blood banking, microbiology, and pathology.
“Validation Manager improved our calculation and presentation of the project of implementing and verifying all analytes on cobas® pro.”
Inger Anne Tveit, Quality Manager of Biomedical Chemistry Lab, Sørlandet Hospital, Lab of Arendal
1CHALLENGE
Major verification project arising from new instrument implementation
The laboratory needed to implement a new cobas® system, which comprised four cobas® pro and two cobas® pure devices across three locations. As a result, they needed to verify all their immunology and clinical chemistry analytes.
Upon learning about Validation Manager as a potential solution and receiving positive recommendations from other Norwegian labs, they decided to implement Validation Manager to tackle this challenge more effectively, shifting away from legacy systems and traditional, Excel-based approaches.
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2SOLUTION
Transforming the verification workflow with Validation Manager
The laboratory began using Validation Manager shortly after the introductory session. Faced with a tight verification deadline and challenges retrieving middleware data from their instruments, they initially relied on manually prepared Excel files for data import. Validation Manager’s flexibility in supporting Excel uploads allowed them to get started immediately and meet their deadline. Since then, their process has evolved. They now import data directly from the middleware into Validation Manager, streamlining their workflow and notably improving efficiency.
Since implementing Validation Manager, the accuracy of verification results has improved. Previously, the laboratory calculated the average difference between series, but with Validation Manager they can now use a more detailed bias calculation. This has also lead them to reconsider some of their goals.
The verification of a large number of analytes has simplified the result review process, saving considerable time. The laboratory can effortlessly obtain an overview of the data and easily track which analytes require additional samples or which do not meet the established goals.
Additionally, traceability has improved as raw data can now be quickly located and traced back from the results directly within Validation Manager. The standardized, automated reports Validation Manager produces make accreditation easy and have received approval from Norwegian accreditation based on ISO 15189.
2SOLUTION
Transforming the verification workflow with Validation Manager
The laboratory began using Validation Manager shortly after the introductory session. Faced with a tight verification deadline and challenges retrieving middleware data from their instruments, they initially relied on manually prepared Excel files for data import. Validation Manager’s flexibility in supporting Excel uploads allowed them to get started immediately and meet their deadline. Since then, their process has evolved. They now import data directly from the middleware into Validation Manager, streamlining their workflow and notably improving efficiency.
Since implementing Validation Manager, the accuracy of verification results has improved. Previously, the laboratory calculated the average difference between series, but with Validation Manager they can now use a more detailed bias calculation. This has also lead them to reconsider some of their goals.
The verification of a large number of analytes has simplified the result review process, saving considerable time. The laboratory can effortlessly obtain an overview of the data and easily track which analytes require additional samples or which do not meet the established goals.
Additionally, traceability has improved as raw data can now be quickly located and traced back from the results directly within Validation Manager. The standardized, automated reports Validation Manager produces make accreditation easy and have received approval from Norwegian accreditation based on ISO 15189.
“It is easy to get support from Validation Manager’s staff, and they follow up all issues making sure the problem gets solved.”
Inger Anne Tveit, Quality Manager of Biomedical Chemistry Lab, Sørlandet Hospital, Lab of Arendal
3RESULT
A more productive way of working
Thanks to Validation Manager, the laboratory successfully met the project deadline. “Validation Manager improves our result overview and standardizes the reports, making it easier to read and understand the work that has been done,” says Inger Anne Tveit, Quality Manager of Biomedical Chemistry Lab. “People in the medical labs lack the time for quality improvements, so we really need easy programs to help us out.” Looking forward, the laboratory plans to continue using Validation Manager for quantitative verifications.
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