MP: SpecBase - An innovative software tool for automated and efficient quality assurance for clinical mass spectrometry analysis

Liquid chromatography-mass spectrometry (LC-MS) is a gold standard analytical technology that is increasingly used in clinical laboratories. One important factor, which delays its adoption in clinical laboratories, is the lack of tools for an automation and integration of this highly complex technology into the clinical analytical workflow. Moreover, LC-MS specific guidelines for quality assurance were missing until recently. The Hormone Laboratory at Haukeland University Hospital has used LC-MS since 2009 to analyse vitamins, steroid hormones and other hormonal tumour markers. Research carried out by Dr. Ralf Kellmann at the Hormone Laboratory has identified critical instrument parameters and algorithms for the quality assurance of clinical LC-MS data. The parameters and algorithms formed the basis for the development of the software solution SpecBase in 2011, which was implement at the Hormone Laboratory in 2012. SpecBase provides a unified and vendor-independent interface, which delivers complete control over the clinical LC-MS analysis process, including sample chain of custody, automated quality assurance and control, audit trail, and result reporting. An important part of SpecBase is the traceability of results to the reagents, calibrators and quality controls, as well as to the operator(s). Finally, SpecBase gives an instantaneous overview over the entire instrument park, which makes it easier to detect and troubleshoot instrument errors, and to optimise maintenance procedures. SpecBase has been tested at the Dept. of Clinical Biochemistry, University Hospital of Southern Manchester (UHSM). In spite of the COVID-19 pandemic, we successfully provided local software installation and updates, user training, and technical support via virtual solutions. SpecBase was deemed a unique and superior tool compared to existing data management and quality assurance solutions for clinical LC-MS.

In this project SpecBase is validated to market fit at a clinical laboratory, and was deemed superior to existing solutions, as the latter are not designed for clinical LC-MS technology. SpecBase was evaluated, when implemented in full routine operation, to potentially save time and resources in the analytical process, reduce risk of human error, and to increase quality of analytical results through automated quality assurance. Important areas for further development are identified to improve SpecBase, and a clear commercial strategy for the national private- and international markets is formed. Additionally, we probed the Norwegian public health sector through a webinar for clinical laboratories in all Norwegian public health regions with strong interest. Follow-up interviews were carried out with 4 laboratories to discuss user needs and possible implementations of SpecBase, and further labs will be interviewed. A cost-model for the public sector is also under development.