Standardizing Standards in Digital Pathology

During the last year, I (Martin Kristensson- learn about me here) have spent more and more time on the deployment of our clinical diagnostic solutions, working closely with the European hospitals. When we began, I was surprised to discover how little standardization there is within pathology. I am not expecting, or necessarily recommending, that every hospital in the world follow the same set of guidelines; it is more an observation that everyone has their own way of staining, sectioning, imaging, storing and even scoring the slides. Even when it comes to imaging and data management, which is a method of standardization, there are huge differences. Compared to other fields, such as radiology, image formats have already been standardized with a DICOM format and are archived with a PACS system. So why are the same imaging and data management standards not applied in digital pathology?

Pathology Glass SlidesOn a recent visit to a hospital in Switzerland, I met some very visionary pathologists who have been struggling with digitization and standardization for some time now. Yet, their vision sounds very simple. They want one PC, with one screen, running one software package, where they can perform all the necessary work to sign out a patient case. Essentially everything should be tied together by the LIS system or some other software package. A small part of this large-scale project, which is far from finished yet, is to convert digital images to a DICOM format and have barcodes identify samples all the way from accession, to whole slide image creation, and case sign out. Sounds reasonable, right?

Unfortunately it’s not simple. Even though NEMA’s WG-26 worked extensively on solving difficulties and the issues with converting whole slide formats into the DICOM format, the work and results were diluted when the methods were patented, by one of the participants in the working group, limiting the availability of the DICOM storage methods. In this case, the advance of standardization for digital pathology was limited by the industry – not the pathologists. Another barrier is that commercial solution providers often create their own proprietary methods, making it impossible to combine technology, equipment, or software from different companies. For example, many built-in barcode readers do not support barcodes created in other systems, and various PACS only supporting a limited number of image formats.

In my opinion, a truly effective standardization of the digital pathology market cannot take place until the industry supports it! This requires open discussion, technology which can be made available to all solution providers to support interoperability, and a willingness of solution providers to follow those standards. When we as solution providers remove the barriers for change, change is a lot more likely to occur.

At Visiopharm, we have more or less dedicated the past couple of years to standardization. This has led to a very close collaboration with the NordiQC, a Scandinavian based standardization organization, aiding hospitals in optimizing their staining and tissue preparation protocols. Our goal is to deliver a plug-and-play solution that will support medical professionals in making the best diagnosis possible, based on standardized methods. A cornerstone in our goal is that the entire solution has to be compatible with all major whole slide formats, limiting the need for file format standardization, and fit into any existing workflow. Today, we are very close to our goal in Scandinavia. Even though we still have a lot of hard work ahead of us, we have a strong commitment from the involved hospitals and some very impressive results so far. One of the main reasons for the recent advances is that we, as a solution provider, have come to realize that it is not just about the solution, the image analysis workflow and tools, but also about making people and organizations ready to accept the change we create for them. Regardless of how good we are at developing software or setting up standardized workflows, it will all be worthless if it does not fulfill the expectations of the users who will be working with the system every day.