Middleware and Cloud-based systems drive efficiency in the clinical laboratory
By Jason Booth, MBA(HCM), MLS(ASCP)CM
Clinical laboratories play a critical role in patient care. Today, however, labs are under increasing pressure to produce fast, accurate results amid increasing test volumes and diminishing resources. Among the factors increasing demands on laboratories are the ever-growing need for testing, expanded diagnostic markers developed out of scientific advances in molecular and genetic medicine, and a shift to outcomes-focused, value-based care.
Increases in test volume have rarely been met with corresponding increases in lab resources. In fact, many labs are experiencing reductions in resources. Cost pressures, staffing shortages, space limitations, and time constraints are leaving many laboratories looking for solutions that can create operational efficiencies and ensure effectiveness of care.
Information technology (IT) offers many benefits to overburdened laboratories. IT solutions can help standardize processes to promote consistency, accuracy, and productivity. A laboratory information system (LIS), for example, stores and tracks patient data related to a lab visit, including test orders, processing, and results. At its core, it is a repository of information. A laboratory information management system (LIMS) is similar to an LIS, in that it houses information. But while an LIS is patient-focused, a LIMS is dedicated to sample management and associated data.
Both LIS and LIMS are designed to reduce manual and administrative functions, and allow faster, easier data processing. Middleware systems form the bridge between instrumentation and LISs, providing the tools that connect all aspects of laboratory operations to strengthen the utility of information.
Limitations exist with traditional IT solutions, though. System costs, IT infrastructure, and cumbersome implementation processes preclude some laboratories—particularly low-volume laboratories—from taking full advantage of all that IT has to offer. Smaller laboratories may not have the budget or laboratory space to purchase and house onsite data centers, or the personnel to manage and maintain them.
Cloud-based technology is changing that. The Cloud essentially refers to digital information that is remotely stored in large data centers and linked via an Internet connection. This is in contrast to data that are stored using products such as disks, thumb drives, hard drives, and local servers that require physical possession or proximity for access to information. Cloud technology lowers storage requirements, and offers the expanded bandwidth available on the Internet. Information in the Cloud is accessible on demand from any connected device, which means that it is attainable at any time from multiple locations and can be shared among those with the proper connections and credentials. Newer IT systems, with Cloud-based technology, are creating opportunities for a broader group of laboratories to streamline operations and elevate patient care through fast and easy access to data, data-sharing capabilities, and systems that enhance usability. With Cloud-based technology, there is no longer a need to purchase, install, and manage traditional software; and the reduction in hardware footprint saves space and IT resources.
Laboratories are also tasked with securing sensitive patient information while adhering to strict data management requirements. Cloud-based technology may help improve security, as information may be better preserved in the Cloud than when tied to a dedicated, onsite computer system that could be vulnerable to malware and system failures.
Now more than ever, the clinical laboratory is at the forefront of patient care. In the United States alone, clinical laboratories perform seven billion tests a year.1 Clinicians rely on laboratories for vital information to support patient care decisions, prevent disease, and mitigate disease progression. The aim is to help improve outcomes and reduce the healthcare cost burden while meeting the organization’s operational goals.
Advancing technology is one factor leading to the rise in testing requests, including instrumentation with greater precision and capabilities to identify, define, and manage diseases. Increased knowledge in the areas of molecular and genetic medicine, as well as growth in recent years in the number of disease-state markers that help to diagnose and manage such diseases as cancer, diabetes, and heart-related conditions, are among the factors leading to a rise in testing requests. These factors place high demand on laboratories to increase workload, but resources are not keeping pace. Talent gaps, network consolidations, and cost pressures have compelled laboratories to do more with less.
Laboratories are driven to positively affect patient care by delivering accurate results with fast turnaround times, so they continuously seek solutions that help create efficiencies in workflow. Utilizing Cloud-based IT solutions has helped laboratories streamline workflow and improve both processes and services.
This was the case for Jefferson Hospital, a 37-bed general acute hospital in Louisville, Ga. The hospital was looking to create greater efficiency and consistency in its processes through automation. It found its solution in the DxOne Workflow Manager from Beckman Coulter, Brea, Calif, the first Cloud-based middleware solution offered by a major in vitro diagnostics (IVD) vendor (Figure 1). With this new technology, Jefferson Hospital was able not only to decrease the amount of time spent on system implementation, it also lowered turnaround times by reducing the number of test results needing manual verification.
The Role of IT in the Clinical Laboratory
Laboratories produce vast amounts of data. As the healthcare industry has moved its way through the Information Age, technology offerings have expanded the amount of information that can be collected. This is particularly true in the past couple of decades. The idea has been to gather as much information as feasible to create a complete picture of the patient in order to more quickly diagnose diseases and determine treatments.
Laboratory professionals also rely on data to better understand operations and evaluate laboratory performance. Recently, with the shift from a service- to a value-based healthcare model, there is increased desire not just for data quantity, but also for data quality. Laboratories want information that is not only plentiful, but also readily accessible and actionable. In this new landscape, IT is necessary to transform this data and information into actionable solutions that help laboratories address their most urgent needs. These include:
- Faster turnaround time.
- Improved workflow efficiency.
- Reduced workload burden.
- More consistent uptime.
- Lower cost of ownership.
While great strides have been made in these areas, traditional IT systems have some limitations. Installation requires instrumentation to be offline for periods of time, which can affect laboratory productivity and delay critical results delivery. Existing IT infrastructure must be in place, along with IT personnel who can support the systems from an organizational standpoint. Furthermore, system capital expenditure may make implementation too costly for some facilities, especially low-volume laboratories. Ongoing management and maintenance, software purchases, and upgrades may not only bring added expense but increased staff burden.
Middleware and Cloud-Based Technology
Two fast-growing segments of the clinical diagnostics industry that are delivering on a number of fronts to improve laboratory operations are middleware and Cloud-based systems. Independently, each helps to improve data utilization and interoperability to target areas of laboratory concern. Combined, they are broadening the scope of what has been achieved with middleware systems to date.
Middleware. Today, the healthcare middleware market stands at $1.9 billion. It is growing at an annual rate of 10% and is expected to reach $3.07 billion by 2023.2 Of the four middleware market segments—clinical, financial, operational, and administrative—the area of clinical middleware is growing the fastest.
Middleware brings a number of advantages to the laboratory. By connecting instrumentation and automation, middleware consolidates and arranges data into a usable manner that touches almost every aspect of laboratory workflow. The interconnectivity of such systems delivers high levels of standardization for process and results consistency. Added to this are autoverification rules and quality control management, which can result in improved resource allocation and efficiency. Autoverification enables exception-based sample management, allowing technologists to verify only results that fall outside of laboratory-defined rules, which can help to reduce labor requirements, improve turnaround time, and ensure consistent results.
Using autoverification, Jefferson Hospital was able to save time by focusing only on outliers. After implementation, the hospital laboratory achieved an 82% autoverification rate, which resulted in a decreased need for manual verification of results (Figure 2). In turn, these results decreased turnaround time by 27%.3 The laboratory, in essence, gained the equivalent of three-quarters of an employee, which helped it to deal with resource constraints (Figure 3).4
Cloud-Based IT Solutions. In addition to managing more information, it is crucial for laboratories to protect the security and integrity of the data to ensure laboratory operational success. Housing information in the Cloud can protect against data losses caused by system crashes, help drive efficiency, reduce workloads associated with uploading and managing software on dedicated computer systems, lower costs, and expand usability of data on mobile platforms.
According to West Monroe Partners, the healthcare industry appears to be leading the way in adopting Cloud-based systems. A study of 300 technology leaders in three industries revealed that 35% of healthcare companies use the Cloud to house more than 50% of their data or infrastructure, compared to 31% of those in the energy and utilities sector, and 18% of organizations in the financial services industry.5 Moreover, study respondents believed that using the Cloud for information helped to lower risk and reduce costs. Other research indicates that a reported 84% of healthcare organizations store sensitive information in the Cloud.6
Product providers are supporting the move to Cloud-based systems, giving careful consideration to privacy and cybersecurity factors. For example, Beckman Coulter is committed to ensuring secure, proprietary connections to data in adherence to multiple regulatory frameworks and standards on how protected health information (PHI) and personal and sensitive data are accessed, transferred, and stored. Beckman Coulter has formed a global product team that has implemented privacy and security as an integral part of the company’s product development processes. Safeguards have been implemented to protect the confidentiality, integrity, and availability of PHI as well as other personal and sensitive data. Some of these protections include encryption at rest and in transit, virtual private networks and access controls, and dedicated regional private Clouds.
Costs and IT infrastructure are often barriers to adoption for low-volume laboratories seeking middleware solutions. The Beckman Coulter next-generation Cloud-based middleware solution, DxOne Workflow Manager, offers unique advantages, especially for low-volume laboratories.
With DxOne Workflow Manager, laboratories use existing IT hardware, mitigating the cost of additional hardware and requiring less support from hospital IT personnel. This helps to lower costs and eases the pathway to implementation. Much of the work for implementation can be performed remotely, meaning that there is little disruption to laboratory operations. With DxOne Workflow Manager, laboratories of all sizes can gain the benefits of improved information interoperability and utilization.
For Jefferson Hospital, DxOne Workflow Manager meant that the system could be installed with minimal disruption to its daily operations as much of the setup was performed remotely, offsite. This reduced onsite implementation time.
Quality control is another area positively affected by Cloud-based middleware. Consolidation of quality control creates added efficiency and helps elevate the quality of care. Integrating quality control into middleware solutions means laboratories can extend monitoring beyond commercial controls to enhance reliability. They can use rules and alerts to warn technologists of exceptions and stop requests for a particular instrument or test.
The clinical diagnostics industry is ever-evolving. Clinical laboratories provide results that are foundational to patient care and disease state management. Laboratory decisionmakers want solutions that address the challenges they are facing: rising costs, increasing staff efficiency, lack of IT and laboratory infrastructure, and managing data integrity and security.
In vitro diagnostic product providers seek to offset risks by developing innovative and secure solutions that can link systems across networks to deliver actionable analytics related to instrumentation performance, patient results, costs, quality control, and more. Cloud-based technology reduces hardware requirements, preserves laboratory space, reduces the need for IT infrastructure and support, and lessens the operational impact of implementation. Moreover, Cloud-based middleware solutions can elevate system performance, with such features as autoverification and quality control management.
Together, these enhancements can help laboratories reduce turnaround time, address resource constraints, streamline workflows, and ensure precise results for optimal patient care.
Jason Booth, MBA(HCM), MLS(ASCP)CM, is global clinical informatics product manager at Beckman Coulter Diagnostics. For further information, contact CLP chief editor Steve Halasey via [email protected].
- Clinical laboratory personnel shortage [online]. McClean, Va: American Society for Clinical Laboratory Science, 2019. Available at: https://www.ascls.org/advocacy-issues/workforce.
- Value of lab testing [online]. Washington, DC: American Clinical Laboratory Association, 2019. Available at: www.acla.com/value-of-lab-testing. Accessed January 16, 2019.
- Healthcare Middleware Market by Type: Communication (RPC, Message Oriented Middleware), Platform (Web, Portal, Database), Integration (ESB, BPM, BAM), Application (Clinical), Deployments Model (On-premise, Cloud), End User: Global Forecast to 2023. Northbrook, Ill: Markets and Markets, 2018. Available at: researchandmarkets.com/research/mrngdr/healthcare?w=4. Accessed January 17, 2019.
- Jefferson Hospital: Cloud-Based Middleware Solution Opens the Door to Greater Efficiency and Faster Turnaround Times for Low-Volume Laboratories [white paper, online]. Brea, Calif: Beckman Coulter, 2019. Available at: www.beckmancoulter.com/en/learning-and-events/case-studies/cloud-based-middleware-jefferson. Accessed February 15, 2019.
- Signature Research: Technology is Transforming Everything: Businesses Struggle to Change with It [white paper, online]. Chicago: West Monroe Partners, 2018. Available at: www.westmonroepartners.com/insights/white-papers/technology-is-transforming-everything. Accessed January 28, 2019.
- Top cloud security risks for healthcare [online]. Irvine, Calif: Netwrix, 2018. Available at: https://blog.netwrix.com/2018/04/02/infographics-top-cloud-security-risks-for-healthcare. Accessed January 28, 2019.