A laboratory is perhaps Valhalla when it comes to testing. Maybe, because it is not perfect. When it comes to testing Laboratory Information Systems (LIS), we see a completely different picture. Experience shows that there is little priority for testing LIS. It is mainly seen as 'waste'. We see that IT is outsourced and there is little feeling about it. The lab is often a small group in the hospital and priorities lie elsewhere. But if the lab is not running, this can cause major problems. Add to that the fact that next year all labs must be ISO 15189 certified. This raises the question of how best to deal with these challenges.
ISO Certification in 2020
How are you as a laboratory going to meet the certification if you do not have a sound test process or test environment? Let alone sufficient time and resources. The ISO 15189 standard sets requirements for the laboratory's information system. This confronts you with the question of whether to introduce an entirely new system or to perform an (extensive) upgrade. In both cases, this has consequences for the requirements of test cycle. The entire system must be demonstrably tested and approved. Clinical support must continue. Complex processes must remain under control and compliance with laws and regulations must be guaranteed.
Case lab system Radboud UMC
So how do you successfully test a lab system? Recently, Radboud UMC did an implementation of a new LIS called GLIMS from software developer MIPS. As a starting point for the test cycle to be set up, product risks and and ISO standardization were taken. Especially for the ISO standardization, validating the test results was an important part. Given the size of Radboud UMC, this meant an equally extensive test cycle. In order to manage this properly, Radboud UMC uses the tool Testersuite under the guidance of Salves. Radboud UMC has already been working with Testersuite within various projects. Since this tool is platform independent, this choice was easily made.
The LIS has been successfully taken into production at Radboud UMC. However, testing continues to play an important role from a management perspective. The test cases and test approach used in the implementation phase are now continued in the management situation. Quality control is therefore guaranteed.
Webinar
Based on the case described above, MIPS, Salves and Testersuite are introducing the webinar "Implementation of a lab system; crisis or controlled process? On September 5, 2:00 p.m., this 45-minute webinar will be held. This webinar has already taken place. Request a link to the recording of the webinar using the button below. Please include "link to webinar GLIMS" in the email.
