Abstract
Total testing process in a clinical laboratory is designed to produce useful information for patients and clinicians. The changing landscape of healthcare industry forces clinical laboratory leaders to meet the needs of their stakeholders, maximize operational efficiency and improve overall quality of patient care at the same time. The increasing number of data produced force healthcare services industry to digital transformation.
Digital transformation is a process of change which includes finding solutions to novel and unmet requirements of an industry by integrating information, computing, communication and connectivity technologies to minimize the number of low-value tasks and focus on high-value tasks. As the process of digital transformation includes not only the modernization of IT infrastructure but also a paradigm shift in perception of value creation and delivery to improve the quality and cost-effectiveness of laboratory operations in the long run, financial, managerial, and educational issues have been blocking the widespread implementation.
Clinical laboratories are at the crossroads on the road to the future. Laboratories that fail to align themselves with data-driven practices will risk losing a competitive advantage. In this review, strategies for a successful digital transformation will be overviewed in the context of clinical laboratory settings.
Introduction
Clinical laboratories are knowledge and service-based enterprises that can be also considered as complex information systems and essential parts of healthcare networks. Clinical laboratory practice involves acquisition, creation, evaluation and dissemination of information [1].
The increasing number of data produced daily drives the clinical laboratory leaders to navigate their strategies. Digital transformation may sound like yet another fancy buzzword adopted from information and communication technologies industry. However, it becomes an imperative for healthcare, as well as for clinical laboratory services. Clinical laboratories are at the chasm of digital transformation. Those who cannot cross this chasm will lose their competitive advantage and have less chance to survive in the future – in the digital health era.
Practices and processes involved in clinical laboratory management have the potential to be improved by digital transformation. Not only the patient results, but also data produced during total testing process are very beneficial to give insight for managerial decision-making. However, there are some challenges like accessing, processing, sharing, real-time analysis and visualization of data in clinical laboratories. To overcome these challenges, clinical laboratories should take action to overview their existing processes and find out solutions and tools to re-design the system.
Digital transformation may seem like solely a technical issue and a part of information management. However, digital transformation is as much about organizational change as it is about change of technology. As digital transformation is at the intersection between business, people and information technology management, it comprises of laboratory and IT strategy alignment, technology adoption and change management whereas information management includes only technical responsibility of system continuity and maintenance. By digital transformation, enterprises aim to improve of business activities or solving specific industry-related issues using novel digital technologies whereas information management aims to manage information and data collected during business activities using designated, conventional tools.
The aim of this review is to summarize the concept of digital transformation and overview convenient strategies for implementation of digital transformation in the clinical laboratory context which was covered as an invited talk entitled “Crossing the chasm: Strategies for digital transformation in clinical laboratories” during the 3rd European Federation of Laboratory Medicine (EFLM) Strategic Conference held virtually on 25th–27th of May, 2022.
Digital transformation – a new tale of clinical laboratory management
Clinical laboratories deliver knowledge-based services including the acquisition, creation, evaluation and dissemination of information which can be considered as the main product [1]. The success of the service delivery mainly depends on three objectives which can be adapted from project management: Time, cost and quality (Figure 1) [2]. The daily practice of clinical laboratory management involves balanced trade-offs between these components.
Triangle of objectives in clinical laboratory services (adapted from Barnes, 1988).
Clinical laboratory practice comprises of execution of total testing process which can be considered as a cycle of information and information management is an essential task of clinical laboratory leadership [1]. Objective decision-making based on data and information gathered and/or produced throughout the total testing process is required to sustain a successful clinical laboratory. The changing landscape of healthcare industry forces clinical laboratory leaders to do more with less. Clinical laboratories struggle to meet the expectations of their stakeholders, maximize operational efficiency and improve overall quality of patient care at the same time under increasing pressures of workload, costs, and threats of commoditization [3].
Clinical laboratories are major data sources of healthcare. The increasing number of data produced daily drives the clinical laboratory leaders to navigate their strategies. Not only the patient results, but also data produced during total testing process are very beneficial to give insight for managerial decision-making. However, there are still some challenges like accessing, processing, sharing, real-time analysis and visualization of data in clinical laboratories.
The changing environment of clinical laboratory services and data produced force clinical laboratories to undergo digital transformation. Digital transformation can be described as a process of change which includes finding solutions to novel and unmet requirements of an industry by integrating information, computing, communication and connectivity technologies to minimize the number of low-value tasks and focus on high-value tasks and empower clinical laboratories for the future of healthcare services [4]. As contemporary goals of clinical laboratory management comprise of improving quality of care, health-related outcomes, patient safety and optimizing costs, the strategic goals of digital transformation in clinical laboratories is to optimize and re-design elements of total testing process through implementation of novel digital tools to improve the laboratory’s operational efficiency, allocate resources to improve the value and quality of services, improve overall patient experience, optimize patient outcomes, apply data-driven innovations and implement evidence-based decision making within the daily practice.
Drivers of digital transformation
Health care delivery is rapidly changing with the rise of new technologies. Traditional processes are becoming increasingly outdated and healthcare providers are struggling to keep up with the changing landscape. Key drivers of Digital Transformation in clinical laboratories are the needs and expectations of clinical laboratory and its stakeholders (Figure 2).
Key drivers of digital transformation.
The future of healthcare services is expected to be shaped by digital transformation. Digital transformation can bring the opportunities of improving diagnostic procedures, optimizing processes, advancing access of patients to healthcare services and data, creating and delivering more value. Digital transformation can be at enterprise level, as well as at regional system level. The process of digital transformation of a national health system can be a convenient solution to enable achievement of predetermined health goals at national level; for instance, preempting diseases, preventing staff shortages, improving public health by population health data management and analytics, etc.
The rising demand for cutting-edge healthcare solutions is putting a strain on healthcare providers as they struggle to leverage new technologies while maintaining patient safety and security. With an ever-evolving digital ecosystem, it has become more difficult to keep up with the latest trends and developments in healthcare. By leveraging trends in healthcare – from telemedicine to wearables and IoT, from Blockchain to Big Data Analytics platforms – healthcare providers can stay ahead of the curve and ensure that their organizations are able to leverage the latest technologies for enhanced patient care [5].
Benefits of digital transformation in clinical laboratories – unlocking new opportunities
One of the major tasks in clinical laboratory practice is managing data created within the total testing process. However, conventional ICT tools are not sufficient enough to extract information from data. As laboratories have been transformed into production plants with volume-based approach, data-driven process management is required not to omit patient safety despite increasing workload. In the current environment of laboratory medicine, novel needs have emerged that are unmet by existing laboratory information systems (LISs). Increases in workload, expectations on service quality, pressure to decrease the operational costs force laboratory professionals to monitor workflow and data created by operations more meticulously. Every log related to processes or errors belonging to daily workflow is considered as essential data. In cases of proper entry of data and storage in accessible forms, datasets can be investigated to extract new information for management.
Digital transformation can bring the opportunity of implementation of data-driven management approach to clinical laboratories. Data-driven clinical laboratory management depends mainly on real-time collection analysis of process data. Recent systems lack some features such as access to data, processing of data, sharing of data, real-time data analysis and presentation. As managerial decisions have to rely on information extracted from laboratory data, one of the most important skills for laboratory management is data-centric mindset.
By adopting digital transformation strategy, clinical laboratories can gain managerial insights from existing data, identify areas for internal performance improvement (utilization management, quality control practices, turnaround time, cost, errors, etc.), track quality indicators continuously, improve health-related outcomes of patients. These opportunities to change the value creation and delivery can be realized by the implementation of informatics tools like business intelligence, expert systems, decision support systems, data analytics platforms, AI/ML applications; adoption of state-of-the-art IT infrastructure, full connectivity, seamless reporting, real-time data collection and analysis [6, 7].
Today, data-driven management approach requires adoption and integration of novel digital technologies into complex infrastructure of health information systems to improve clinical decision-making. In this context, clinical laboratories are trying to move from testing the technology to implementing it at scale to maximize impact and develop integrated IT solutions to improve clinical laboratory management.
Recently, IT companies and even some of the IVD companies have come up with IT solutions for operations management. These IT solutions are specifically developed for medical laboratories. From basic QC follow-up to clinical decision support, these software are mainly designed to facilitate laboratory management with many functions and increase laboratory’s efficiency by data-driven approach (Figure 3). Starting new services with implementing data analytics into real-time process monitoring can create opportunities for predictive reporting or cumulative risk analysis for patients whereas Business Intelligence (BI) systems can be established to route the workflow and gain operational and financial insight.
Possible functions to be achieved by digital transformation in clinical laboratories.
Business intelligence (BI) can be defined as solutions providing/facilitating to reach strategic targets, increase efficiency, improve patient-clinician satisfaction and full compliance to legal regulations. New decision-making mechanisms can be plotted with business intelligence software. BI systems can impact on the design of processes and accelerate decision making processes and may induce reduction of costs, improvement of patient outcomes, reaching quality goals, monitoring functional/dynamic structure of organization and determining required changes for the future [8]. Features of business intelligence software such as specificity to laboratory, user-friendliness, convenience of establishment and maintenance, adaptability, cost-efficiency has to be evaluated by laboratory specialists thoroughly for functional/useful business intelligence.
Data collection and processing improves managerial insight of laboratory specialists. Data-driven managerial approach can be realized with technological innovations. Production of test results in medical laboratories is not a service that only includes the test analysis step. Services like counseling about accurate test selection before analysis, interpretation of results, and recommendations for further investigations are also included in diagnostic services provided by medical laboratories. Accurate testing and accurate assessment of outcomes are important extra-analytical steps required to make more efficient use of the laboratory. The extreme overspecialization in medicine and rapid development of new diagnostic tests highlight the role of the laboratory in interpreting diagnostic test results. Test utilization management and test interpretation can be streamlined by the help of novel digital technologies to deliver more value to patients and physicians. To support utilization management, decision support systems can be implemented.
Conventional quality control (QC) practice includes analysis of QC materials within predetermined periods of time which may overlook systematic errors. Patient-based QC practice by monitoring real-time patient results can be adopted with new generation laboratory informatics tools.
Digital transformation in clinical laboratories can also occur through the creation of a rich health data foundation, integration of technologies like Internet of Things (IoT), advanced analytics, machine learning (ML), artificial intelligence (AI) [5].
Key challenges
The delivery of healthcare services on digital level mainly depends on connectivity and interoperability through integration of health information systems and merging data sources. Novel digital solutions will focus on patients’ expectations from healthcare services and help to re-design the processes. Through the power of connectivity, patients and physicians will benefit from the health data maximally.
Most of the clinical laboratories still have traditional IT artifacts consisting of laboratory information systems which are mainly client/server or desktop applications with no to very basic components like middleware, business intelligence/analytics, decision support system and monolithic software architecture, on-premise data storage facilities and limited computing abilities.
In order to cross the digital transformation chasm, clinical laboratories need to assess the depth of the technical debt which is the overall cost of course correction from existing systems to scalable, flexible, resilient IT infrastructure. Technical debt of an enterprise comprises of incorrect managerial decisions that ended up investing in legacy information systems that are based on outdated technologies, short-term programming and systems-architecture decisions.
Legacy information systems are user-hostile software incompatible with diverse operating systems. Legacy systems can have security and/or compliance issues, the technical support can be discontinued.
Digital transformation – an issue of strategic management
As known from the experiences of other industries, almost 70% of DT projects fail [9]. The most common features of these projects are being complex and large-scale. Here are possible reasons of DT project failure:
Insufficient or missing objectives
Insufficient strategy and roadmap
Lack of executive commitment and alignment
Lack of change management approach
Lack of project management approach
Insufficient governance and design of key performance indicators
Lack of technical vision
Looking for only internal solutions
Not focusing on the right issues in the workflow
Taking on too many things at one time – radical transformation [10]
Digital transformation is a process that aims to improve an entity by triggering significant changes to its properties through combinations of information, computing, communication and connectivity technologies. Even though the concept may sound like a technical issue, it is not only about modernization of IT infrastructure. To overcome key barriers of digital transformation (Table 1), the process involves mainly managerial responsibilities like alignment of business and IT strategies, planning of DT strategy, change management, transformational and learning-oriented leadership [11].
Key barriers of digital transformation in clinical laboratories.
| Complexity of clinical laboratory services |
| Lack of resources |
| Resistance to change – perception of threat |
| Inability to experiment quickly |
| Risk aversive culture |
| Reluctance to invest |
Digital transformation process consists of adoption of new IT artifact which is bundle of hardware infrastructure, software applications with relevant content and resources to achieve specific goals and/or serve unmet needs of an organization. Information technologies to be adopted via digital transformation are expected to be reliable, scalable, safe, affordable or worth investing and tailored to the digital maturity level of the organization.
Adoption of a new IT artifact depends on multiple factors. From technical to managerial and social aspects, there are some critical factors that can be classified in five main categories as technology, organization, environment, data/information and stakeholders [12].
Readiness of clinical laboratories for the digital transformation process can be assessed by the following critical factors of adoption:
Digital maturity level of the enterprise: Digital maturity is a learned characteristic of an entity that represents its ability to respond to the environment in an appropriate manner [13]. It is rather a relative and subjective concept with regard to both the surrounding working environment and time and a result of continuous and ongoing process of adoption to a changing digital landscape.
Digital competence level of employees: Digital competence of employees can be revealed by assessing their information and data literacy, their awareness on safety/security, their communication, collaboration and troubleshooting skills [14].
Laboratory – IT strategy alignment: The strategic goals and priorities of both IT department and clinical laboratory management should be consistent in order to achieve successful implementation of a digital transformation project [15].
Digital transformation roadmap
Start with the analysis to identify where in the value chain your laboratory waste time, money or effort
Determine the organizational issues and prioritize them:
Examples:
Need for process optimization
Data quality improvement
Disruptions in software development lifecycle management
Legacy software architecture and components
Need for more functions in the software
Choose your transformation strategy
Radical vs. incremental
Top-down vs. bottom-up
Strategy for implementation
Legacy system modernization
Adoption of new IT artifact
Make or Buy decision
Make decision – in-house or outsourcing
Buy decision – tools and vendors to choose
Design
Estimation of organizational impact
Transformation (implementation/operation/review): Utilization of proper tools to monitor DT roadmap (digital adoption platforms, feedback gathering tools, training materials, digital bullet journals, communication channels for employees, etc.)
The digital transformation roadmap of your organization has to be tailored for your specific features and needs such as size of the laboratory – number of admissions, number of samples, number of tests, variety of the test menu and methods/instruments, presence of bottlenecks in the workflow, pain points in value chain, predetermined goals, etc.
Conclusions
Questions to ask before starting a digital transformation project are:
How to disseminate the vision?
Key success factors of digital transformation?
What is successful leadership?
How to recognize a successful process of digital transformation?
Laboratories can implement successful digital transformation projects by “paying off” the technical debt, choosing solutions fit for the digital maturity level, choosing the right roadmap fit to your organization and adopting either radical or incremental approach – regarding the organizational culture and organizational readiness for digital transformation.
Digital transformation is an ongoing process and unique to each organization. There is no one-size-fits-all approach. In a learning, data-, patient-, and value-centric organization, a successful digital transformation project can be executed.
Digital transformation can empower clinical laboratories for the future of healthcare services. Clinical laboratories with a vision of intelligent enterprise, precise laboratory – IT alignment strategies, high-level digital maturity and no to minimal technical debt can cross the digital transformation chasm.
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Research funding: None declared.
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Author contributions: Single author contribution.
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Competing interests: Author states no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
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