Digital transformation towards the clinical laboratory of the future. Perspectives for the next decade

Introduction

Digital transformation of clinical laboratories, the process also known as “digitalization”, involves the use of digital technology to collect data, automate processes, establish trends, and mark better business decisions. It is the drive force of the 4th Industrial revolution – Industry 4.0, the application of which in laboratories is referred as Lab 4.0. The transformation to Lab 4.0 requires processes that improve digital maturity [1].

Clinical laboratories are major data sources of healthcare. Often laboratories are seen as a factories – you send a request and get a report back with some numbers and figures. Laboratories are receiving a huge amount of data, which in fact is the treasure of healthcare organizations and by extracting insights from it, it is possible to shift from being a manufactory site to a decision engine, driving action across healthcare. To successfully take advantage of this new environment and respond to the new kind of expectations, clinical laboratories need to evolve by undertaking digital transformation.

COVID-19 pandemics was a major disruption for clinical laboratories that highlighted the necessity of digital transformation and its acceleration. The Forrester’s report showed that those that were more advanced in this field more easily adapted to the “new normal” [2]. This so-called digital maturity requires establishing connectivity, end-to-end workflow, and advanced analytical technologies and techniques. The key role in all these steps have digital technologies – the Internet of Things (IoT), artificial intelligence (AI) and machine learning (ML). However, the role of laboratory personnel and scientists needs to change, focusing from routine to more complex and meaningful work. This requires their empowerment in working with new instruments and software, as the most important part of the whole transformation process [1, 2].

In this transformation process, with orientation towards implementation of high-level technology and digital health, clinical laboratories cannot lose focus on quality. Quite the opposite, reducing laboratory errors, eliminating unnecessary testing and challenges of global harmonization will dominate the laboratory medicine professionals’ activities. On the other side, clinical laboratory services will expand to demand management and to consultations regarding laboratory test results [3]. Also, laboratory medicine professionals will need to collaborate closely with AI experts who are working on algorithms that should use big data obtained through different diagnostic processes, among which laboratory medicine has an important and sometimes a key role, for improvement in patients’ care [4].

Strategies for digital transformation

Current global aspirations in healthcare are directed towards improving patient outcomes without financial repercussions. The key drivers that enable them are technological developments and patient empowerment [5]. Laboratory medicine has been a playground of intensive implementation of technological innovations since it already relies in great extent on technology. These innovations, named disruptive innovations, are enabled by intensive digitalization. Some examples are the implementation of next generation sequencing, turning towards primary care pathology, using dry chemistry reagents and point-of-care testing (POCT), use of AI and integration of different fields of medicine, but also the use of social media in clinical practice, education, and publication. There are several challenges for this process, starting from resistance of IVD industry, regulatory issues, lack of trust from patients and medical professionals, limited availability of the new technologies, to the demand for the new business model that would support it, along with moral and licit doubts. These need to be overcome with a series of actions that include, first, composing an adequate business model that involves multidisciplinary collaboration, appropriate accreditation, and regulatory control, but then also commercialization, modernization, enhancing knowledge translation, and promoting disruptive innovation [6, 7]. Also, in order to work in digital environment, medical professionals would need knowledge about data management and structure and quality of digital data. These should be received through an adequate education, both through undergraduate curricula and postgraduate training [8].

Virtual and mobile learning experiences

Healthcare technologies have developed rapidly to support healthcare professionals and increasing need of monitoring, screening and diagnostics tools which affects the decision making. Sustainable learning schemes through continuous collaboration between technology manufacturers and medical experts make it possible.

The patient outcome has been considered as a sum of clinical effectiveness, patient experience and safety. Quality of the outcome surely depends on advanced technologies and human factor in terms of medical and technical expertise, thus making need for continuous learning and professional development crucial.

Due to pandemic face-to-face events have been very limited and moved to virtual environment. However, diversity has not always been achieved in terms of delivery. The teaching methods could not always keep up with the pace of technology development. New reality caused by pandemic and changing environment towards digitalization in general clearly shows us the need to develop different virtual and mobile learning opportunities that would prepare us for future needs and ensure the best outcome for patients.

Interoperability

Interoperability is basically synonym for communication [9] between different information systems, devices, and applications [10]. It is defined as “the ability to access, exchange, integrate and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally” [10]. It is obvious that the digital transformation is crucial for interoperability, but also the digital transformation depends on interoperability. Consequently, interoperability will help deliver better care at a lower cost, leading to patient outcomes of higher quality. Achieving these goals requires all relevant data to be accessible without barriers and uniformly interpretable. However, sharing data makes them more vulnerable to cybersecurity threats and privacy breaches [11]. To prevent this, but also to provide an undisturbed communication between systems and/or devices, implementation of a set of standards is required enabling users (clinicians, laboratories, hospitals, pharmacies, and patients) to easily share relevant information. The standards are related to vocabulary/terminology, content, transport, privacy and security, and identifiers [10]. They are also capable of delivering audit and measures for access and control [11].

Thanks to interoperability and digitalization, there will be no borders between central laboratory and POCT, and results from both sources will be implemented into the electronic medical records and thus be available equally. This will facilitate fast and accurate diagnosis at the hospital admission, but also guarantee the adequate monitoring at home, after leaving the hospital [12].

Conclusions

In the era of the Lab 4.0 clinical laboratories will move from a mere data production to directing decision making. Digital transformation is essential for this process. However, to implement it, many challenges need to be overcome. This process requires, most of all, education of laboratory medicine professionals on the new environment, which needs to be continuous. To keep up the pace, the very education is also changing, moving from traditional to virtual environment. And finally, the critical point in enabling digital transformation to achieve better patient care is developing interoperability. These topics were elaborated during the session “Digital transformation towards the laboratory of the future. Perspectives for the next decade” at the 3rd EFLM Strategic Conference, and the lectures will be presented in this special issue of CCLM by the speakers.