Use of Middleware to Increase Clinical Laboratory Efficiency

Middleware Overview

With increasing demands on productivity and decreasing resources, clinical laboratories are looking  for  ways to reduce staffing costs, reduce review rates, optimize sample throughput, and improve accuracy and consistency of reported results. While laboratory information systems help to achieve these goals, the use of middleware to increase efficiency has become an industry standard.

Middleware—software that optimizes the data flow from analyzer to LIS—is a necessity for any viable laboratory. Through the use of customizable rule sets, QC monitors, and tools that aid technologists in releasing results quickly and accurately, middleware improves efficiency and productivity. Middleware eliminates the need for staff to review every result, and also reduces the number (and cost) of paper printouts.

Autoverification

Perhaps the main benefit of middleware is autoverification. By applying rules to test results coming from the analyzer, the middleware filters the data before it reaches the LIS. Results that do not meet release criteria are either automatically scheduled for rerun or re-analysis or are reviewed by technologists who have control over the results from that point.

How Does Autoverification Work?

Middleware programs use Boolean logic—“IF”, “AND” , “OR” statements— to establish rules for analyzer data review. Results from the analyzer that meet release criteria are sent directly to the LIS, while results that fail these criteria are held for further action by a technologist or by other laboratory staff. For example, if chemistry analyzer test results fail release criteria, the test(s) may be automatically re-ordered or the technologist may be alerted to review the results to decide if further testing is required or if the results can be released. In a hematology application, differential results that fail release criteria may require that a blood smear is made and reviewed microscopically by a technologist prior to them being released to the LIS.

The Clinical and Laboratory Standards Institute® recommends the following as minimum requirements when considering software tools for autoverification¹:

• ability to use multiple data elements in an unrestricted fashion
• ability of the laboratory to define and implement changes to algorithms quickly and easily
• retrieval of selected information from multiple data sources (e.g., EMR, pharmacy, instrument results, other laboratory data, diagnosis code)
• application of algorithms in real time
• flexible user interface that provides laboratory-defined information on the autoverification process in real time

Laboratory Performance Metrics

Another benefit of middleware is the ability to track laboratory performance metrics. Because results are released in “real time”—i.e. as they come off the analyzer or as they are reviewed by a technologist— the software can track analyzer throughput as well as technologist performance and overall turnaround times. A further benefit is the ability to track data at a granular level, such as determining review rate by review rule, follow-up action, patient age, or species (in multi-species applications).

Implementation

Implementing middleware in a laboratory involves working closely with a middleware vendor (such as LabThroughPut). A team incorporating laboratory operations managers, IT administrators, and vendor programmers works together to install the middleware, to ensure that instrument interfaces and data transfer are properly implemented and to determine that review rules are properly created and that the  right follow-up actions are performed. Any middleware’s Autoverification rules must be customizable to meet specific laboratory standard operating procedures, and so that changes can be implemented if needed.

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Resources

1.       Clinical and Laboratory Standards Institute. Neeley, et.al. Autoverification of Clinical Laboratory Test Results; Approved Guideline. Volume 26, Number 32.