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DIGITAL PATH0LOGY A Utrecht medical centre now operates a fully digital workflow for primary diagnostics Strategies and demands for digital pathology workflow integration The digital age in diagnostics dawns Three-step process for digital pathology of pathology, the analysis of tissue slides from different labs is difficult, the specialist regrets. There are no unified standards regarding histo- logical colourings. ‘Each laboratory produces slightly different depths of colours, so the sections differ from one another. Pathologists are not normally worried by a stronger pink or blue – a computer, however, then may have problems with the clas- sification. The objective is the devel- opment of procedures which are independent of colour,’ he empha- sises. Although previously not an important topic in pathology, these types of standardisation are works in progress, having gained impor- tance only with the introduction of digitisation. Klauschen sees a further difficulty in the practical implementation of digitisation in day-to-day pathology. ‘Although we have the technology available, scans of sections are only compiled for special studies, confer- ences, or for research projects. The actual pathology workflow is not digitised.’ One reason for this is the vast number of tissue sections pro- duced at the Institute every day and the related expenditure of time for the digitisation of each section. The data volume of the images still represents a big problem as patho- logical images have much larger file sizes than those in radiology, for instance. ‘We have amounts of data which simply represent big challeng- es for the IT infrastructure. There is room for development here, particu- larly regarding the archiving of all this data.’ Klauschen is aware of only two institutes where the workflow is completely digitised – one in the Netherlands, the other in Sweden. Despite the numerous challenges the pathologist believes that digital pathology means progress, which, in future, will also play an important part in the integration of conven- tional-morphological and molecu- lar pathology. ‘Fluorescence-in-situ hybridisation visualises genetic changes in the tissue. Digitisation and computer-assisted evaluation can be of enormous benefit here. ‘I also believe that digital pathol- ogy will become important for the interpretation of molecular profiles in the tissue context.’ ‘The whole world wants to stop by and see the show,’ said Paul van Diest MD, who leads the Department of Pathology at the Utrecht University Medical Centre. Why? In March 2016 the centre began to run a fully digi- tal workflow for primary diagnos- tics. The centre is now overwhelmed with requests for visits. flow system, so that we can now do the diagnostics in a different way,’ he said. ‘For primary diagnosis we no longer use the microscope, we are looking at a digital image on a screen.’ ‘I can not give you a precise per- centage because, during this transi- tion period, we haven’t logged any numbers, but my gut sense is that at least 90%, possibly as much as 95% of the diagnostic work, is now done in a completely digital way, which I think is pretty good for the first month.’ In May 2016, a highlight of the European Congress of Digital Pathology in Berlin will be a Roundtable Session on ‘Digital Pathology Workflow Integration,’ where van Diest will share with fellow pathologists his pioneer- ing experience and some lessons learned. ‘Change management will be my first bullet point,’ he said during our interview. ‘Stepping away from the microscope is a revolution for the average pathologist, so you have to make sure you have everyone on board to do something this radical. This means influence and involve- ment, the key terms.’ It’s about the people you need on-board to help with project management ‘My second point will be to make sure you get the right stuff, because it’s difficult to make an optimal sys- tem with the wrong stuff,’ he said with a laugh, adding that ‘It’s not just about the hardware, it’s also about the people from the company, who you will need to have on-board to help with project management, because it is very complicated to bang this down. ‘Then it becomes important to design upfront exactly what you want,’ van Diest advises. ‘This sounds obvious, but you need to get the design really right – the architecture for the system. To know what you want to have in the end becomes critical at the beginning.’ Following a pan-European tender, the Utrecht pathologists selected a line of scanners from Hamamatsu Photonics of Japan and a workflow informatics system from Sweden’s Sectra. The conversion, over five months, to digital for diagnostics was less a revolution than an evolution for the pathology group in Utrecht, which has been regularly handling digital images with an archiving system set up in 2007 for the retrieval of old cases, whether for comparative study, for research or education. Thanks to this early experience with archiving, the Utrecht group was also prepared for the mas- sive storage challenge the new Frederick Klauschen MD is a pathologist, physicist, lecturer and consultant as well as Head of the Molecular and Systems Pathology Group in the Institute for Pathology at the Charité University Clinic in Berlin. Up to 2009 he worked at the National Institutes of Health in Bethesda, USA and he is currently a Junior Fellow at the Einstein Foundation in Berlin. Paul J van Diest MD, took charge of the Department of Pathology at the Utrecht University Medical Centre in 2003. He is a full professor at the university’s medical school where, to date, he has personally supervised 57 PhD theses. He is also an Adjunct Professor of Oncology at the Sidney Kimmel Oncology Centre at Johns Hopkins in Baltimore, Maryland, USA, and serves on the editorial board of 23 international journals. Professor van Diest has also served as president of several international societies and published more than 600 papers in peer-reviewed journals. Pathologists in Utrecht step away from the microscope as the first fully digital workflow goes live for primary diagnostics, John Brosky reports As laboratories in Europe shift to systems for digital pathology, they must ensure the technology not only works, but works for them, says Dr Liron Pantanowitz, director of pathology informatics at University of Pittsburgh Medical Center (UPMC). Lisa Chamoff reports On 27 May, at the 13th European Congress on Digital Pathology in Berlin, pathologist Dr Liron Pantanowitz, from the Pittsburgh Medical Center will give the keynote address ‘Strategies and demands for digital pathology workflow integra- tion’, discussing how to bring digital technologies into a laboratory with- out disrupting the processes already set up. ‘Just because you’re bringing in new technology doesn’t mean you’re going to do a better job,’ Pantanowitz confirms. ‘The people have to be willing to work with the technology and be efficient.’ Later in that 3rd day of the con- gress, Pantanowitz will also par- ticipate in a roundtable discussion on Digital Pathology Workflow Integration. In his keynote address, the pathologist will go over the three- step process for digital patholo- gy: pre-imaging, imaging and post imaging, providing strategies for incorporating scanning of slides into a lab’s workflow, and discussing the importance of training people to do high-quality imaging to create the best slides and how laboratories can make decisions about saving immense amounts of data. Going digital could have a nega- tive affect on a laboratory’s work- flow if, for example, employees batch all the work of scanning slides, or if there’s downtime, Pantanowitz points out. If laboratories follow the right integration strategies, he adds, they can take advantage of the many benefits of a digital system -- using computer-aided diagnostic tools and conducting image-based searches, Pantanowitz will also touch on his work with Onyx, a company that provides digital pathology technol- ogy and is a joint venture between GE Healthcare and UPMC Digital pathology is gaining ground in Europe faster than in the USA, Pantanowitz points out, with less stringent regulations governing its use. The country’s Food and Drug Administration (FDA), which regu- lates medical devices, states that digital pathology cannot be used for primary diagnosis. While the USA’s laboratories can use digi- tal pathology technology ‘off label’, they risk being held liable if there should be a malpractice case. As a result, three laboratories in Europe have gone fully digital, according to Pantanowitz, while he is not aware of any fully digital laboratories in the USA. UPMC runs a digital pathology consultation service, providing sec- ond opinions to pathologists, clini- cians and patients around the world, which provides the facility with an additional revenue stream. The Pittsburg Medical centre is in the process of collecting data regarding the use of digital meth- ods for primary diagnosis to help make the case for using digital technologies for primary diagnosis, Pantanowitz adds. It was a bold move into the digital age where van Diest convinced the University Medical Center to roll forward the next five years of capital spending for the pathology depart- ment to pay for the new system in the first year. ‘We replaced the old scanners, we set up a completely new server architecture and a work- Dr Liron Pantanowitz is Director of Cytopathology at UPMC Shadyside. He is also Director of the Pathology Informatics Fellowship Programme and Associate Director of the Pathology Informatics Division. S P E C I A L : D I G I T A L P A T H O LOGY Continued on page 13 11 www.healthcare-in-europe.com

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