Avoid These Gaps: Six Benefits Your Laboratory Middleware Solution may be Missing

The Rise of Middleware Solutions

Healthcare organizations are keepers of information. Since the introduction of the spirometer and electrocardiogram in the 19th century, clinicians have based care decisions not only on subjective observation, but also on objective clinical evidence. As the quantity and quality of information has increased, so has the drive to manage and use it in a way that supports efficient, outcomes-based care.

Two prominent healthcare information management systems with distinct roles support this pursuit.

• The laboratory information system (LIS) – a solution for storing and tracking historical patient data related to laboratory visits, including physician test orders, analytical processing and results.
• The electronic medical record (EMR) – an electronic version of a patient’s medical chart, including a medical history, health conditions, test results, diagnoses and medications.

While these systems contribute to better, more streamlined patient care, opportunities to extract more from the data remain. Moreover, they are desired, especially in a value-based economy. Middleware is key to tapping into those opportunities.

Clinical middleware is the fastest growing segment of the middleware market, increasing by an estimated 10% a year. The market, which stood at 1.90 billion USD in 2018, is expected to reach 3.07 billion USD by 2023. In response to this rapid rise, a number of developers have entered the space, presenting a variety of options, as well as some confusion as to what middleware is exactly.

What Middleware is—and what it is not

Most often, clinical laboratory middleware is defined as software that resides between the instrumentation/analyzer and LIS. The term also refers to an EMR-LIS connection, however. Among instrument-LIS interface systems, capabilities differ in that some middleware is single discipline or analyzer-specific.

The advantage of laboratory middleware that links instrumentation and automation to the LIS—compared to a LIS extension or analyzer-specific middleware—is that it can facilitate the information among all laboratory systems for greater data accessibility, utility and actionability. With middleware designed specifically for laboratories, clinicians gain accurate and timely results to assist in patient care. Moreover, laboratory middleware gives technologists the unique ability to customize their workflows and standardize best practices for error reduction and can help to improve turnaround times (TATs).

As analyzer and informatics continue to advance—delivering greater insights more efficiently—so must middleware capabilities expand. The most versatile systems are those with the ability to interface with a range of instruments, automation and informatics to positively impact the performance of the laboratory, as well as the organization as a whole.

Six Unique Advantages only a Robust Middleware System Can Deliver

Customizable auto verification/automatic reflex rules for productivity and performance

In the laboratory, rules streamline workflow and ensure quality results. Middleware gives technologists the power to adjust rules according to specific workflow needs and quality requirements to help improve TATs and alleviate staff workload burden. With laboratory-defined auto verification and automatic reflex testing rules, results falling out of range are flagged for review or repeat analysis; results meeting rules criteria are advanced to the LIS for delivery to clinicians. This allows technologists to manage samples by exception, freeing time for other value-added tasks. When laboratories standardize these customized rules across networks, they gain even greater process predictability and efficiency, improving results quality and consistency for patients.

Additional insight for out-of-range results to inform and standardize next steps

High-performing middleware solutions extend capabilities beyond rules-based auto verification and automatic reflex. They connect dots, illuminating indicators that can help standardize additional actions for technologists. Autovalidation brings efficiency to normal and expected results. The small percentage of samples that do not pass auto validation, however, require attention. It is important to not only identify those results, but also to gain a level of efficiency in the manual steps that follow.

For example, follow-up decisions for a MCHC >38, held for review, typically are not made based on one single result. Technologists rely on other flags and results. In this example, a robust middleware solution can look at other indicators (H&H check fail or RBC agglutination flags) and guide next steps based on standardized processes. In other examples, these steps may include a saline replacement, dilution, sample warming, advanced reflex, add-on tests or delta checks. Data-driven indicators can help technologists verify results by creating consistency as to which manual steps to take for workflow efficiency throughout departments.

Multidisciplinary connectivity for a comprehensive analysis of each sample

Multidisciplinary system connectivity enables comprehensive analysis of each sample. Middleware that can link hematology, chemistry and immunoassay analyzers, for example, allows laboratories to apply rules and logic based on multivariable for these disciplines. As such, the middleware can either auto validate a sample to the LIS or signal additional actions, including a rerun, reflex, review or reroute to another work area manager. Including these variables from different analyzers offers clinicians a well-rounded diagnostic view of the patient’s condition.

Confidence in Quality Control management through advanced capabilities for compliance assurance

A diligent QC program helps to establish high test-result quality. Laboratories vary in their QC management protocols—from manual processes to advanced, automated systems. Middleware can make the latter possible. With robust middleware, facilities can help promote QC compliance and consistency. They offer around-the-clock assurance that QC standards are met by preventing orders from downloading to failed QC instruments and, instead, rerouting the samples to analyzers where QC passed. By this, they help avoid delivery of compromised results.

Advanced systems provide laboratories with enhanced QC capabilities that streamline maintenance and stop auto validation if a single parameter is outside of compliance. These systems also have a timeout feature to verify QC is completed on schedule, and they use exponentially weighted moving averages to identify issues proactively between scheduled QC runs.

Consistency through system connectivity and compatibility for seamlessness

Because laboratory middleware is designed specifically to integrate with laboratory instrumentation, there is an elevated level of performance and consistency that fills interoperability gaps. With middleware, laboratories can get the most out of their automation investments and enable automated sample reflexing/rerunning. Additionally, with direct connection to the analyzers, technologists have insight into reagent, QC and pipettor information for every result. With this level of detail, they are able to search for and quickly find specific samples.

Comprehensive solutions through expert consultation

Because laboratory middleware systems are specialized, they can be tailored to the needs of the laboratory. More than just system integration, they play a role in a total laboratory solution that takes into account an organization’s goals, including testing volumes, patient populations and staffing requirements. By leveraging the expertise of dedicated middleware partners, a laboratory can take advantage of benefits beyond data streamlining. These include setting and implementing strategies to meet performance goals, planning test menu expansions, reducing workload tasks and training laboratory staff to be self-reliant with system operation. This eases implementation and sets the laboratory up for high levels of success. Similarly, when using middleware, instrumentation and automation from a single manufacturer, not only is system performance enhanced, but also the laboratory can ease operations by having one source for ongoing service and support.

The drive to do more with less is only increasing for laboratories grappling with growing demands and shrinking resources. Laboratory middleware solutions offer a conduit for easing operational burden and enhancing patient care.

Is your middleware solution giving you the efficiency and options your laboratory, physicians and patients need? Find out how you can transform your workflow and patient care through high-performing middleware.