A laboratory is perhaps Valhalla when we talk about testing. Maybe yes, because it is not completely perfect. When it comes to testing Laboratory Information Systems (LIS), we see a completely different picture. Experience shows that there appears to be little priority for testing LIS. It is mainly seen as ‘waste’. We see that IT is being outsourced and there is little feeling about it. The lab often forms a small group in the hospital and priorities are elsewhere. But if the lab is not running then this can cause major problems. Add the fact that next year all laboratories must be ISO 15189 certified. The question then arises how to deal with these challenges.
ISO certification in 2020
How are you going to meet the certification as a laboratory if you don’t have a thorough test process or test environment? Let alone that sufficient time and resources are available. The ISO standard 15189 sets requirements for the information system of the laboratory. This asks you whether you are introducing a completely new system or whether you are doing an (extensive) upgrade. In both cases this has consequences for the requirements of the test process. The entire system must be demonstrably tested and approved. The clinical support must continue. Complex processes must remain under control and compliance with laws and regulations must be guaranteed.
Case lab system Radboud UMC
How do you successfully test a lab system? The Radboud UMC recently did an implementation of a new LIS, called GLIMS from software developer MIPS. The product risks and ISO standards have been taken as the starting point for the test process to be set up. Validating the test results was an important component, in particular for ISO standards. Given the size of the Radboud UMC, this meant an equally extensive test process. To control this properly, Radboud UMC uses the Testersuite tool under the supervision of Salves. Radboud UMC has been working with Testersuite for several years in various projects. Since this tool platform is independent, this choice was therefore made easily.
The LIS has since been successfully taken into production at Radboud UMC. However, testing continues to play an important role from the management. The test cases and test approach as implemented in the implementation phase are now being continued integrally in the management situation. Quality control remains guaranteed.
Based on the case described above, MIPS, Salves and Testersuite introduce the webinar ‘Implementation of a lab system; crisis or controlled process? ” This 45-minute webinar will be held on 5 September 14:00. Use the button below to register (webinar will be in Dutch).