The age of epidemics is here with infectious diseases, especially zoonotic diseases expected to emerge and reemerge as globalization and growing population encroach into wild animal environments and habitats. Laboratory diagnosis is an essential element of communicable disease surveillance and epidemic management. Laboratory information systems (LIS), in this regard, helps in making labs more efficient and productive by automating sample handling; reducing time spent on processes; auto-authorization of reports; elimination of human error; reduced costs; and easy scalability of operations.
As demand for testing has soared during the pandemic, many labs with little experience in infectious disease or molecular testing have added such assays to their offerings.
And while instrument and reagent shortages are among the foremost challenges laboratories faced in ramping up COVID testing, lab information systems (LIS) have also proved a major chokepoint.
In a recent survey of healthcare systems by consulting and lab optimization firm Accumen, labs identified LIS resources as one of the major challenges they currently face, with more citing this as an issue than the supply chain problems that have hampered SARS-CoV-2 testing efforts.
A major source of lab LIS challenges is the fact that for many facilities, SARS-CoV-2 testing requires handling considerably higher test volumes than previously. This creates a strain at multiple points throughout the process, but especially so where the lab’s internal routines make contact with the outside world — taking in samples and reporting out results.
Due to the pandemic, labs are scrambling to implement fully electronic sample accessioning systems to help them handle the increased test volumes.
A small laboratory has maybe three to five people in accessioning, and if they crest anywhere over 600 samples per day, they feel overwhelmed. Technicians have been accessioning 12 to 18 hours a day at labs where COVID was high and the CIO, CEO, and COO all have been accessioning alongwith the regular staff because they were all manual.
The need to get accessioning to be 100 percent electronic and not have to relabel specimens when they come into the lab and let them go directly into the lab has never been more important.
Even labs that have fully electronic accessioning systems could run into problems if those systems weren’t tailored to the higher-throughput demands of SARS-CoV-2 testing.
The volume challenges were compounded by the fact that SARS-CoV-2 testing was also being done in a variety of environments outside traditional healthcare settings that labs don’t typically interact with, and with which their LISs may not be easily able to interface.
The other end of the process, reporting results, has also been difficult for labs not accustomed to dealing with this kind of testing. Many labs still rely on fax, couriers, manual processes for getting results back, and need something that can get them back to providers a lot faster.
COVID testing orders are coming in through the system. They are going to have to receive the samples and run them, manually, unless they have a solution there. And then on the back end, when they have to send the results back, that is also going to be a manual process. 50 samples a day can be handled manually. They can call the physicians, they can fax over the results. But when tests per day start scaling up into the hundreds and thousands, labs have to have an automated, IT solution.
The global laboratory information system market is expected to decline from USD 1.62 billion in 2019 to USD 1.58 billion in 2020 at a compound annual growth rate (CAGR) of -2.42 percent, estimates ResearchAndMarkets. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach USD 2.33 billion in 2023 at a CAGR of 13.8 percent.
A growing number of people are undergoing a series of tests, which in turn, increases the burden on the laboratories. The clinical laboratories are hiring more healthcare personnel to reduce the amount of workload on existing staff and minimize the number of errors associated with it in order to increase the efficiency and efficacy of the lab’s functioning for accurate results.
According to the Bureau of Labor Statistics, around 12,000 additional clinical laboratory professionals are required every year to meet the demand; however, only half the number is entering the field. Thus, laboratories opt for automation to ease the work. For instance, TriCore Reference Laboratories in Albuquerque, Mexico, introduced automation in 20 percent of its instrumentation, which performs almost 80 percent of the lab’s samples and displays helping the lab in managing and optimizing its functions for faster and accurate results.
Cloud computing is associated with the sharing of computer resources and services, including storage and servers over the internet for a reduced cost, increased speed, productivity, and security of the system in the network. The cloud system in laboratory information systems offers various advantages such as cost-efficiency, better results, and progress without space constrain. For instance, APEX laboratory information system by Apex HealthWare, LLC, Arxspan Laboratory Software by Bruker Software Solutions, Orchard laboratory information system by Orchard Software Corporation are cloud-based systems, which improve efficiency, reduce errors, and enhance patient care. Thus, a cloud-based laboratory information system is expected to gain significant traction in the laboratory information system market.
The cost of a laboratory information system ranges from USD 4000 and USD 100,000 and also an additional annual operating cost of USD 1000 to USD 5000. The operating costs comprise cost related to the software license, training the healthcare personal, maintenance, and service cost. The laboratories may opt for the lower-cost version owing to the high cost of software even when the requirement is for a higher-cost version to reduce the burden of the laboratories, causing an operational instability. Therefore, the high cost of a laboratory information system is expected to hinder the market.
The Americas is likely to dominate the global LIS market owing to the increasing adoption of healthcare IT and favorable incentive programs. The region is estimated to dominate the global market over the next few years. The Americas is expected to reach USD 20,757.12 million by 2025 with a CAGR of 7.1 percent from 2019 to 2025 owing to many key players and technologically advanced healthcare infrastructure in this region. The factors that are leading the market in the Americas are technological advancements, the cost-effectiveness of LIS, increasing the use of cloud computing and web-based solutions, rising aging population, increasing demand for better healthcare systems, an increasing number of chronic diseases, consolidation of healthcare providers, and innovation and improved efficiency.
Europe is the second-largest market for LIS, owing to increasing incidences of diseases and growing awareness about new technologies related to various laboratories. The government agencies are supporting the laboratory information systems as it is advance management of the health-related laboratory studies and testing.
Asia-Pacific is predicted to be the fastest-growing market during 2020-2025. In the region, the laboratory information systems market in Japan is commanding the largest share, followed by China and India. In China, LIS market is influenced by the rising geriatric population and extensive use of healthcare IT. Emerging economies, such as Singapore, Australia, India, and China, are the most lucrative markets due to rising elderly population, increasing the patient pool, and improving healthcare facilities. The increasing awareness about electronic healthcare record systems and their growing importance coupled with the supportive government programs and policies are expected to boost the LIS market in the region during 2020-2025.
The Middle East & Africa has the least market share, due to the presence of middle-income countries, lack of healthcare awareness, and lack of advanced technology. The laboratory information systems market in the region is segmented into the Middle East and Africa. Saudi Arabia and the UAE dominate the region in terms of market shares owing to a good economy, skilled laboratory professionals, and accessibility to modern technology.
Key players operating in the global laboratory information system (LIS) market are Cerner Corporation, McKesson Corporation, Epic Corporation Inc., Medical Information Technology, Inc., SCC Soft Computer, Sunquest Information Systems, Inc., CompuGroup Medical AG, Computer Programs and Systems, Inc., Merge Healthcare, Inc., and Orchard Software Corporation.
The COVID-19 crisis has put tremendous administrative burden on staff due to initial shortcomings of LIS. The realization that digitalization, automation, and meaningful use of LIS could alleviate some of the most important administrative bottlenecks provided a sense of emergency, which accelerated the development, implementation, and adoption of new functionality. It would be beneficial to maintain such dynamics after the COVID-19 crisis to advance LIS functionality that may ultimately increase efficiency and quality and improve employee engagement by removing repetitive and administrative tasks. Applying the Kotter principles for consolidating a dynamic environment, or similar change management strategies, can significantly accelerate health IT implementation and adoption. Kotter proposed a 3-step change model. The first step, establishing a sense of urgency, is the most difficult, but is absolutely required to create an environment that stimulates the meaningful use of health IT.
The development of robust IT solutions typically requires several months to implement, which is not sufficiently fast for the acute phases of crisis management. However, it is important to immediately develop a near-term (days to weeks) plan for the implementation of IT tools that can alleviate the administrative burden on personnel and facilitate epidemiological and scientific research and reporting.
The COVID-19 pandemic is especially challenging for clinical laboratories that are tasked with rapid and reliable testing of a significantly increased number of samples. Demand above surge capacity readily clogs standard infrastructure. Alleviating personnel from repetitive and administrative tasks via digitalization and automation using ad hoc–developed LIS functionality and reporting tools significantly streamlines sample processing and reduces turnaround time, features that are also beneficial after the initial phases of the COVID-19 crisis.