SECTION 1
MIDDLEWARE
LEARNING OBJECTIVES
When you complete this section, you will be able to:
• Define middleware in the context of the clinical laboratory
• Identify and understand some of the main functions of middleware
• Identify the main information systems available to integrate patient test orders and results
• Understand the communication stream between middleware, Laboratory Information Systems,
and automated analyzers
LEARNING GUIDE: MIDDLEWARE USE & OPERATION 4
SECTION 1 – MIDDLEWARE OVERVIEW
What is Middleware?
In the clinical laboratory environment, Middleware is defined as software that sits between
automated analyzers and the Laboratory Information System (LIS), enabling transmission and
integration of test orders and results between these systems.1 Middleware was initially developed
to manage laboratory connectivity by supporting seamless integration and communication
between instruments and the LIS. However, more features were added to middleware, and today,
middleware can further enhance the capability of analyzers, as well as optimize the performance
of the LIS.2 Advanced middleware solutions have the potential to significantly improve laboratory
operations with multidimensional capabilities. Major middleware functions include automated
test order management, automatic results validation and reporting, and quality control
management that enable laboratories to more easily comply with local and international regulatory
requirements. With these capabilities, middleware has quickly become a central information
solution in laboratories, transforming the complex information business of the modern clinical
laboratories into a scalable, highly efficient and highly productive operation.3
Middleware and Interoperability
Laboratories often have automated analyzers from multiple vendors. These analyzers usually
have unique communication protocols to allow for the exchange of orders and results, which have
historically presented interoperability challenges for laboratories as they struggled to integrate
these different analyzers and information management systems.
Interoperability is the ability to share data automatically and seamlessly among devices and
information systems.4 Middleware enables a single point of communication with the laboratory’s
main information system, the Laboratory Information System, supporting centralized management
and monitoring of instruments.
Middleware and the Hierarchy of Information Systems
A Laboratory Information System (LIS) is a computer-based application that helps to manage
several aspects of the clinical laboratory, including entry, processing and storing tests orders and
results.5 The LIS organizes all pre-analytical, analytical and post-analytical data associated with the
samples processed by the laboratory.
The LIS integrates with other health care information systems, primarily the Hospital Information
System (HIS) and the Electronic Medical Record (EMR) system. The LIS consolidates patient
test order information from connected HIS and EMR systems, manages the flow of orders to the
middleware, and further directs the flow of results received from the middleware out to the HIS
and EMR.
5 LEARNING GUIDE: MIDDLEWARE USE & OPERATION
A Hospital Information System is a computer-based medical record system that organizes
inpatient health care records. It is a central repository for patient information from ancillary
systems, including the LIS and pharmacy, within a health system.6 The HIS manages tasks
and activities such as order entry for lab tests and medications, as well as operating room and
diagnostic imaging schedules. The HIS stores health care records such as lab results, pre- and post-
operative reports, nursing observations and reports, as well as prescriptions.
An Electronic Medical Record System is a computer-based patient record system that manages
patient health records for a single physician office or a multi-disciplinary outpatient clinic that
is affiliated with a larger inpatient health system.6 The EMR maintains patient demographics,
diagnostic information from the LIS and medication history.
Or
der
Outpatients s
EMR Re
sults Orders Orders
s Results Results
der
Or LIS Middleware Instruments
t s
sul
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Inpatients
HIS
Figure 1.1 Communication diagram showing orders and results flow between middleware, LIS, instruments, EMR and HIS
Middleware Capabilities
There are several providers offering a variety of middleware applications; however, they vary in
functionality. Some middleware applications offer a wide range of solutions to address the diverse
and complex data management and workflow challenges of the core laboratory.7 Every core
laboratory will have different needs and gaps that may be addressed by middleware. There are
also instrument vendors that offer middleware solutions. Abbott’s AlinIQ Analyzer Management
System (AMS) offers a middleware solution with open connectivity that enables integration with
different analyzers.
Considering the workflow and data management needs of the Hematology laboratory, a
middleware solution with a comprehensive set of functionalities, including open connectivity,
can help:
• Streamline complex data processing
• Monitor quality control compliance
• Improve staff efficiency with advanced rules set to autovalidate samples
• Autoverification to automate and optimize results release management
• Provide instrument performance analytics
• Improve the management of multi-lab environments
LEARNING GUIDE: MIDDLEWARE USE & OPERATION 6
Middleware applications host a variety of capabilities to assist the Hematology laboratory and
other disciplines with the management of data, tasks and processes. These capabilities can be
categorized into six main groups:
1. EXPERT DECISION RULES
- Automate workflow and data management processes without the need for manual
intervention
2. TEST MANAGEMENT
- Automates the analysis of patient test orders and results
3. SAMPLE MANAGEMENT
- Manages sample workflow, logistics and archiving to optimize sample processing
4. QUALITY MANAGEMENT
- Monitors assay and instrument quality performance to help ensure accurate results
5. ANALYZER AND LABORATORY AUTOMATION SYSTEM MANAGEMENT
- Controls the performance of instruments and automation track systems
6. REPORTS
- Track and summarize data from connected analyzers
We will explore these capabilities in the sections to follow.
Now complete the section Quiz.
7 LEARNING GUIDE: MIDDLEWARE USE & OPERATION
