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Let's talk about certification... Arnoud Loof

August 24, 2020

Arnoud Loof, ICT coordinator
Arnoud Loof, ICT coordinator

‍Inthis special edition of Let's Talk About Test, we talk to Arnoud Loof, ICT coordinator at Radboudumc. In this interview, he talks about how Testersuite was given an important role in the ISO certification of the laboratory information system. Let's Talk About Certification!

"You know that ISO is going to take you to task".

Just a heads up: Who is Arnoud?

I am Arnoud Loof and I work in Laboratory Medicine at the Radboudumc. In our organisation we have four laboratories. Within one of these laboratories I have been team leader.

What is your role now?

There is a lot of talk about IT in laboratories. Patient diagnostics is about something. So it's not surprising that IT is very important there. Especially that it works well and continues to do so. We regularly ask ourselves 'what if that or that fails'. The impact on patients is very great when applications fail.

We then proposed to create a position for someone to make the link between the laboratories and IT. Eventually, I started doing this myself. It is mainly a coordinating role. I was also assigned the AVG part. It is now a broad function.

How do you handle this?

You map out processes by means of process diagrams. You look at how things run and which IT components play a role in them. When a problem needs to be tackled, we tackle it together with the IT service managers. This is where Testersuite also plays a role.

What certification process did you use Testersuite for?

That was NEN-EN-ISO 15189:2012. The CCKL used to issue certificates to laboratories for this. Nowadays, it is the ISO certification.

The certification process had a great impact when we replaced our laboratory information system GLIMS-8 with GLIMS-9. The new version had a completely different architecture. That meant a lot for all links with diagnostic equipment middleware and links with our Epic EPD. How are you going to arrange and secure this? You have to be able to show this to ISO.

What caused you to commit Testersuite to this track?

You know that ISO is going to put you through your paces. I had to be able to show how Glims-8 had been validated in the past. In some cases, this was not possible. It took me a lot of effort to demonstrate this.

For the new certification, things had to be documented again. Application managers were not used to documenting much.

Eventually, I learned about Testersuite in our organization through Sander Hassert.

"I was a little less popular for a while but now everyone sees the value in it..."

And so everyone got to work on it enthusiastically...

Now Testersuite is embraced by everyone. But in the beginning there was some resistance. People were not used to running and capturing tests through a tool.

When setting up Testersuite , you need to think carefully about how you are going to put things down. What terminology do you use and what conventions do you agree on. There was some resistance in the beginning. Now everyone is glad we did it.

I can find things now. Everything is archived in Testersuite . I was a little unpopular for a while but now everyone sees the value and knows what Testersuite is.

What benefits did this bring?

A system can never be 100% tested. At most, you can get 95%. The question is whether that is enough to go live. If you want to convince the steering committee to go live, you need arguments. For example, before going live I was able to point out to the steering committee that 200 remaining defects were not blocking issues. That helped me enormously. After going live, we continued to work on defects .

ISO also welcomes this evidence. They are impressed. Even after going live, we continue to test and record in Testersuite. Auditors regularly invite us to demonstrate things. That's easy to do now.

Are there functionalities specific to certification pathways that you would like to see reflected in Testersuite ?

When working with external parties, it would be nice if screenshots could be exported in addition to results. I can't imagine working without Testersuite anymore. Testersuite is ideal for me as an audit trail. No idea how other hospitals do this without Testersuite.

What is your advice to other organisations facing a certification process?

Make sure you have clearly agreed on how to call things within Testersuite. This convention is very important for retrieving test results. How big do you make a test cycle. When do you use a chain test, when do you use a record test, and what is the naming convention. You need to be able to find things easily for the ISO. Also for your successors in the future. For a certification process, this is very important.

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