LEARNING GUIDE

MIDDLEWARE
USE AND
OPERATION

COREL ABORATORY. ABBOTT

 CON T EN T S
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

GETTING THE MOST OUT OF THIS LEARNING GUIDE. . . . . . . . . . . . . . . . 4

SECTION 1
MIDDLEWARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

SECTION 2
TEST MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

SECTION 3
SAMPLE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

SECTION 4
EXPERT DECISION RULES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

SECTION 5
QUALIT Y MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

SECTION 6
ANALYZER AND L ABORATORY AUTOMATION
SYSTEM MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

SECTION 7
REPORTS AND ANALY TICS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

APPENDIX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

2 | Learning Guide: Middleware Use and Operation

INTRO D U C TI O N

L E A RNING GUIDE
Middleware has played a critical role in helping to support the efficiency of clinical laboratories for several
years. When it first emerged, the primary value was in connectivity, simply enabling transmission of orders
and results between automated analyzers and the Laboratory Information System. Middleware platforms
have since transformed to expand their value and support the needs of the clinical laboratory in response to
the evolving healthcare landscape.

Diverse and changing demands, including increasing workload, faster turnaround times for patient results,
and regulatory and financial constraints, have created an opportunity for holistic solutions that optimize
clinical laboratory operations. For laboratories to adapt and succeed, they need to understand the capabilities
of Information Technology and explore the role of Middleware in addressing the many challenges of the
modern clinical laboratory.

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G E T T ING T HE MOS T OU T OF
T HIS L E A RNING GUIDE
This learning guide serves as a primer and provides a basic overview of middleware, its use, capabilities
and the benefits of implementing these solutions in the core laboratory, with a focus on applications in
Hematology. Multiple stakeholders in the laboratory can draw insights from the guide, including laboratory
management, Medical Technologists and Information Technology staff.

Each section provides information on different middleware solutions for laboratory workflow and
operations. Middleware platforms vary in their capabilities. The main solutions presented in this learning
guide are advanced options.

SECTION 1 introduces middleware, its fit in the hierarchy of different information systems that support the
management of patient tests, and outlines its capabilities.

SECTION 2 reviews the laboratory test management process and the associated data managed by middleware.
Although test management is discussed in all sections, it’s important to look at this topic independently to
understand middleware’s role in this critical task.

SECTION 3 provides an overview of sample management and some of the main middleware solutions
available to help laboratories better navigate sample logistics and workflow.

SECTION 4 details a fundamental solution offered by middleware – expert decision rules. Key concepts are
defined, approaches to rules, variables to consider and their impact on laboratory workflow are summarized.

SECTION 5 focuses on the role of middleware in quality management, including quality control and moving
average monitoring.

SECTION 6 discusses equipment management solutions for automated analyzers, highlighting Laboratory
Automation Management systems and their interactions with middleware.

SECTION 7 summarizes some of the analytics and reporting capabilities that can be provided by middleware
to help present and make sense of the data processed by laboratories.

At the end of each section, you will find a short quiz to help reinforce and test your knowledge of the
information covered in the section.

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S EC TI O N 1

MIDDL E WA RE
WHAT IS MIDDLEWARE?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
MIDDLEWARE AND INTEROPERABILITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
MIDDLEWARE AND THE HIERARCHY OF INFORMATION SYSTEMS . . . . . . . . . . . . . 6
MIDDLEWARE CAPABILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

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 LEARNING 1 Define middleware in the context of the clinical laboratory
OBJECTIVES
2 Identify and understand some of the main functions of
After completing this section, middleware
you will be able to:
3 Identify the main information systems available to integrate
patient test orders and results

4 Understand the communication stream between middleware,

Laboratory Information Systems, and automated analyzers

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 INTEROPERABILIT Y

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.

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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.

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.

Orders

Results
Outpatients EMR
Orders Orders

Results Results

Orders LIS Middleware Instruments

Results

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.

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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

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. QUALIT Y MANAGEMENT
- Monitors assay and instrument quality performance to help ensure accurate results

5. ANALYZER AND L ABORATORY 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.

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QUIZ QUESTIONS

1. Middleware is defined as software that sits between automated analyzers and the Laboratory Information
System, enabling transmission and integration of test orders and results between these systems.

A True

B False

2. Which of the following health care information system communicates directly with middleware?

A Hospital Information System (HIS)

B Laboratory Information System (LIS)

C Electronic Medical Record (EMR)

3. Match the following:

A Automates the analysis of patient test orders and results _____ 1. Expert Decision Rules

B Monitors assay and instrument quality performance to help

ensure accurate results _____ 2. Sample Management

C Automate workflow and data management processes without 3. Quality Management

the need for manual intervention _____

D Track and summarize data from connected analyzers _____ 4. Test Management

E Controls the performance of instruments and automation 5. Reports

track systems _____

F Manages sample workflow, logistics, and archiving to optimize 6. Analyzer and Automation
sample processing _____ Management

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S EC TI O N 2

T ES T M A N AG E MEN T
THE BASICS OF TEST MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
MAJOR TEST MANAGEMENT MIDDLEWARE CAPABILITIES. . . . . . . . . . . . . . . . . . . . . 11
KEY TEST MANAGEMENT FUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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 LEARNING 1 Describe the basics of test management
OBJECTIVES
2 Recognize major test management middleware capabilities
After completing this section,
you will be able to: 3 Identify key test management functions essential to
Hematology workflow

TEST MANAGEMENT
The primary purpose of the clinical laboratory is to manage the translation of physician test orders into
accurate and precise test results. This requires the coordination of staff, automated analyzers, patient
specimens, supplies and various procedures needed for the processing of test orders and results.8 With this
coordination comes the generation and exchange of a vast amount of data. Implementation of middleware
can help consolidate and manage this data.

Test management is one of the main capabilities of middleware applications. The test management feature
coordinates the tasks required to translate test orders to patient results. Extended capabilities include:

• Visual dashboards that display information about patients and specimens

• Test information such as type of test ordered and results
• And lastly, graphs and images relevant to the laboratory

A robust middleware solution can automate pre- and post-analytical manual tasks and processes, which
reduces hands-on time with samples, analyzers and software interfaces.9 Automated test management
capabilities for ordering, processing and reviewing patient tests and results include:

• Order entry and reporting – enables entry of new patient orders, as a backup to the
Laboratory Information System.
• Test results autoverification – automates the review and release of test results according to
standardized rules.
• Manual test results review – provides a centralized workspace for the laboratory staff to
review and release patient results.

Advanced test management middleware solutions can provide the laboratory staff with actionable
information on patient results. Some benefits include:

• Dynamic worklists with up-to-date information on required activities for pending test orders
and results. A worklist is a list of open or incomplete orders or results that is pending further
action prior to release to the LIS. Worklists can also filter test orders and results by analyzer,
test, quality control or by department, such as Hematology, Chemistry, Immunoassay
or Serology.
• Alerts to draw attention to data that may impact result quality, such as quality control results.

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• Traceability of results using data elements that are not typically captured by the LIS, such
as graphs and images; for example, scatterplots and morphology images that are relevant
to Hematology.
• Dashboards that provide status monitoring for tests in progress, completed or pending further
action.

Middleware can streamline the complexity of Hematology workflow. One of the advanced middleware
solutions for the review and release of Hematology results brings all the relevant information to the
laboratory staff on one screen, including:

• Specimen and patient information

• Current and previous results allowing comparison between sample runs
• Scatterplot graphs from analyzers
• Cell counter results and manual differential keypad
• Morphology results and comments

Figure 2.1 Profile View from Abbott’s AlinIQ Analyzer Management System (AMS) showing consolidated Hematology results. For
illustrative purposes only.

While some middleware applications provide a variety of test management options, highly customizable
solutions offer flexibility to support the unique needs of the laboratory.2 A properly utilized middleware
solution allows users to customize their own views or workspaces to display relevant information, including
specimen and patient information, tests held for manual review or results status for one or multiple analyzers.

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QUIZ QUESTIONS

1. The test management feature coordinates the tasks required to translate test orders to patient results.

A True

B False

2. Match the following:

A Enables entry of new patient orders, as a backup to the 1. Autoverification

Laboratory Information System _____

B Provides a centralized workspace for the laboratory staff to 2. Order Entry

review and release patient results _____

C Automates the review and release of test results according to 3. Results Review
standardized rules _____

3. Which of the following information can be included with results for Hematology samples?

A Patient demographics

B Sample information

C Scatterplots from automated Hematology analyzers

D Automated differential results

E All the above

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S EC TI O N 3

S A MPL E M A N AG E MEN T
DEFINITION OF SAMPLE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
THE IMPORTANCE OF AUTOMATED SAMPLE MANAGEMENT . . . . . . . . . . . . . . . . . . 15
THE MAIN SAMPLE MANAGEMENT SOLUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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 LEARNING 1 Define sample management
OBJECTIVES
2 Understand the importance of automated sample management
After completing this section, in the clinical laboratory setting
you will be able to:
3 Identify the main sample management solutions provided
by middleware

SAMPLE MANAGEMENT
Ensuring patient safety through accurate accessioning, coordination and processing of specimens is a priority
for clinical laboratories. Laboratory staff operate in a very dynamic and distracting environment. Mistakes
can lead to adverse events, such as patient sample mismatch, inaccurate testing and incomplete results.
These mistakes can further impact patient care by delaying diagnosis and treatment decisions. Middleware
can help reduce the risk of human error by automating the coordination and tracking of patient samples, and
improving sample traceability through advanced sample management solutions.

The process of tracking and handling information associated to samples such as patient, specimen and
test information, is referred to as sample management.10 Middleware can provide automated and highly
customizable end-to-end solutions that allow laboratories to display, track and manage samples or specimens
across the health system. A comprehensive sample tracking solution can streamline the entire sample
management workflow, including:

1. SAMPLE LOGISTICS
Track samples at a single laboratory location or between sites for health systems
that transport samples between sites. Advanced middleware solutions use sensors
to monitor sample container temperature during shipment. This can enable
laboratories to ensure sample quality and integrity by tracking sample transport
times and temperatures between sites.

2. SAMPLE WORKFLOW
Monitors sample movement throughout the entire workflow process and between
instruments. This can help the laboratory staff determine where a sample is located
and what work remains, which also helps to monitor results turnaround time.

3. SAMPLE STORAGE
Records storage location of samples in refrigerators or cold rooms for future
retrieval if needed. Some middleware solutions can provide alerts to the laboratory
staff if they are attempting to store a sample that has incomplete tests or additional
testing is required.

With advanced middleware solutions, laboratories can streamline the tasks and processes involved in test
order and specimen management, reduce the risk of human error and even monitor sample traceability in
real time.

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QUIZ QUESTIONS

1. Sample management is the process of tracking and handling information associated to a sample such as
patient, specimen and test information.

A True

B False

2. What are some of the adverse consequences of mistakes in sample management?

A Misidentification of samples

B Inaccurate testing

C Incomplete testing

D Delay in patient treatment

E All the above

3. The ability to track the location of a sample is considered a sample logistics middleware capability.
A True

B False

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S EC TI O N 4

E XPERT DECISION RUL ES

THE DEFINITION OF EXPERT DECISION RULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
THE MAIN TYPES OF RULES USED IN THE HEMATOLOGY LABORATORY . . . . . . . 19
KEY BENEFITS OF IMPLEMENTING MIDDLEWARE RULES
IN THE HEMATOLOGY LABORATORY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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 LEARNING 1 Define rules
OBJECTIVES
2 Understand the anatomy of rules
After completing this section,
you will be able to: 3 Understand the main types of rules used in the
Hematology laboratory

4 Understand the key benefits of implementing

middleware decision rules in the Hematology laboratory

EXPERT DECISION RULES

The Expert Decision Rules function is one of the most popular capabilities and benefits of middleware. They
help automate the manual tasks and processes in the laboratory environment, enabling greater efficiency,
productivity and error reduction along the testing continuum.
Rules are logic statements that define a set of conditions. These logic statements use IF, THEN and ELSE to
define conditions. Rules take the form: IF some condition is true, THEN perform a certain action, or ELSE
perform a different action. The IF, THEN and ELSE statements make up a rule.
• The IF portion of the rule defines a condition or series of conditions to determine if the follow up actions
(in the THEN or ELSE portion) should be taken.
• The THEN portion defines an action or series of actions to be taken if the IF condition(s)is true.
• The ELSE portion defines an action or series of actions to be taken if the IF condition(s) is false.

Rules can be applied to different data elements and processes in the sample testing process, such as orders,
results, and specimen processing status (e.g., specimen received).

The expert rules found in middleware essentially emulate advice that the Technologist would provide,
enabling automation of manual tasks and processes associated with the laboratory workflow. In the
Hematology laboratory environment, these processes include managing CBC and differential test results,
from reviewing results to determine if they can be released to the LIS or further action is needed, to
reviewing results against established laboratory guidelines to determine if it’s clinically necessary to perform
a slide review or manual differential.

Perhaps the most common uses of rules in middleware is for autoverification and autovalidation.
Autoverification is the process where test results are automatically reviewed and released to the LIS or
held for manual review based on a predetermined set of rules established by the laboratory. Autoverification
eliminates the need for human intervention.11 As results are filed into the middleware from the analyzer, they
are automatically reviewed against predefined conditions (rules), and either automatically released to the
LIS or held for manual review by the Technologists if there are exceptions.

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 Result is transmitted
from instrument

Compare with
previous; release Is this
if within YES a rerun?
acceptable limits

NO

Hold for Are results

manual review NO numerical or equal
(possible rerun) to “<#.##” or
“>#.##”?

YES

Hold for
manual review; Does result
add additional have instrument flags
YES
autoverification (or those deemed Round result to
actions here relevant?) the correct
based on flag decimal place

NO

YES
Does the Does the Is the Are previous
result exceed result exceed result Is this the first result and current
NO NO analysis on this NO
high AMR low AMR numerical? result within
(“>#.##”)? (“<#.##”)? patient? acceptable
limits?

YES YES YES

Parameter- Parameter-
dependent dependent
options (hold for Is this result Hold for
options (hold for within the
manual review, NO manual review
review, rerun, verification
rerun, dilute, or release)
or release) range?

YES

Does the
result compare
well with other NO Hold all related YES
related assays for
parameters? manual review

YES

Result autoverified

Figure 4.1 An example of a sequential set of autoverification rules for Hematology results release.11 Although multiple results are
transmitted from the instrument as part of the CBC results for each sample, middleware evaluates each result independently as shown
here. Advanced middleware decision rules can manage this evaluation and complex combination of steps.

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Autoverification of test results in middleware are evaluated against several different parameters.
• Patient demographic information – factors in associated patient demographics (e.g., age and gender)
when analyzing results to determine whether to auto release results, hold for manual review, rerun or
conduct additional testing.
• Critical values – ensure test results are not automatically released when clinical validity may be suspect.
• Delta checks – compares current results for a given test against previous results that exist for the same
patient to determine if, based on established laboratory standards, the difference is acceptable for release
to the LIS.
• Quality control – blocks the automatic release of results if quality control issues are identified.
• Instrument flags/exceptions – prevent the automatic release of results when an associated instrument
flag or exception is detected.

CONDITION 1 CONDITION 2 CONDITION 3

IF NEUTROPHIL absolute value IF NEUTROPHIL absolute value
is less than user defined value OR is greater than user defined value & IF this is the first time seen
(example <1.0) (example >20.0)

Action
Hold sample results (for manual review)

Figure 4.2 Example of an autoverification rule. There are 3 conditions within this rule. Condition 1 and condition 2 are evaluated
first; these conditions look at the absolute value for the Neutrophil result and whether the result is less than 1 or greater than 20. If
condition 1 or condition 2 is true, then condition 3 is evaluated to determine if this is the first occurrence of the Neutrophil result for
the patient. The rule will perform both action (hold sample results) if condition 1 OR condition 2 is TRUE, and condition 3 is TRUE.

Autovalidation is the process whereby sample results are validated automatically based on a predetermined
set of conditions. These conditions may be established by a combination of laboratory standard operating
procedures, instrument vendor recommendations and/or published guidelines, such as the 41 Consensus
Rules developed by the International Society for Laboratory Hematology (ISLH).12 These rules automatically
review and validate CBC and differential results to take actions that might include:
• Ordering a rerun
• Reflexing to a slide review
• Adding comments to notify the laboratory and/or clinical staff

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Although middleware platforms offer different criteria that trigger actions to review CBC and differential
results from automated Hematology analyzers, one of the most widely used standards is the ISLH Consensus
Guidelines. Recognizing that there was little uniformity among laboratories on what prompted the review of
CBC and differential results, Dr. Berend Houwen invited 20 Hematology experts to determine criteria and
develop rules in 2002. These rules were tested on over 13,000 blood samples in 15 laboratories. Following
testing, the data was thoroughly analyzed, leading to further refinement of the rules to a final set of 41 rules.13
The guidelines include rules for CBC numeric results, differential numerical results and morphological flags.
The 41 ISLH Consensus Rules and modified versions are widely used in Hematology laboratories worldwide.

Middleware platforms with sophisticated rules-based solutions, offer the ISLH Consensus Rules as a
predefined rules package for Hematology laboratories. This rules package is typically preloaded with the 41
Consensus Rules and are often configurable so that laboratories may customize parameters and values to
meet their operating procedures and patient population needs. Some of the criteria evaluated in the rules set
include:
• Analytical measurement ranges
• First time events
• Patient age
• Sample age
• Various instrument and morphological flags
• Delta checks

Based on these criteria, the middleware can trigger a variety of actions:

• Slide review
• Rerun
• Hold results for manual review
• Block partial or full results (e.g., block percentage and/or absolute differential results)
• Add comments

CONDITION 1 CONDITION 2 CONDITION 3

IF WBC is less than user IF WBC is greater than user
IF this is the first time seen
defined value (example <4.0) OR defined value (example >30) &

Actions
Hold sample results + Order slide review

Figure 4.3 Example of an autovalidation rule. There are 3 conditions within this rule. Condition 1 and condition 2 are evaluated first;
these conditions look at the value for the WBC result and whether the result is less than 4 or greater than 30. If condition 1 or
condition 2 is true, then condition 3 is evaluated to determine if this is the first occurrence of the WBC result for the patient. The rule
will perform both actions (hold sample results and order slide review) if condition 1 OR condition 2 is TRUE, and condition 3 is TRUE

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KEY BENEFITS OF IMPLEMENTING MIDDLEWARE RULES
IN THE HEMATOLOGY L ABORATORY
Implementing Expert Decision Rules provided by advanced middleware solutions can automate complex,
manual processes and improve the efficiency of Hematology laboratories. Some of the key benefits to the
CBC results review process include:

1. Automation of the results review process can significantly improve results turnaround
time.

2. Elimination of the review of routine, manual results can improve productivity by allowing
the laboratory staff to focus on actual sample exceptions.

3. Minimize tech-to-tech variation during results review through standardization.

Advanced rules solutions are typically customizable and can be adapted and revised as the workflow of the
laboratory evolves.

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QUIZ QUESTIONS

1. Rules are logic statements that take the form: IF some condition is TRUE, THEN perform a certain
ACTION

A True

B False

2. Match the following:

a. The portion of a rule that defines a condition or series of conditions 1. THEN

to determine if the follow up actions (in the THEN or ELSE portion)
should be taken _____

b. The portion of a rule that defines an action or series of actions to be 2. IF

taken if the IF condition(s) is true _____

c. The portion of a rule that defines an action or series of actions to be 3. ELSE

taken if the IF condition(s) is false _____

3. Autoverification is the process where test results are automatically released to the LIS or held for manual
review, without the need for human intervention, based on a predetermined set of rules established by the
laboratory.

A True

B False

4. Autovalidation is the process where sample results are automatically validated based on a predetermined
set of conditions. These conditions may be established by a combination of laboratory standard operating
procedures, instrument vendor recommendations and/or published guidelines, and direct actions that
may include rerunning a sample or reflexing to a slide review.

A True

B False

5. From the list below, please select some of the key benefits of implementing rules in the Hematology
laboratory.

A Improves staff productivity

B Standardizes results review

C Accelerates turnaround time

D Enhances workflow flexibility

E All the above

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S EC TI O N 5

QUA L I T Y M A N AG E MEN T
QUALITY MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
PATIENT MOVING AVERAGES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

24 | Learning Guide: Middleware Use and Operation

 LEARNING 1 Define quality control
OBJECTIVES
2 Define moving averages
After completing this section,
you will be able to: 3 Understand the utilization of automated quality
management solutions provided by middleware

4 Recognize some of the benefits of quality management

middleware functions

QUALIT Y MANAGEMENT
International regulatory organizations that govern clinical laboratory accreditation require laboratories to
maintain quality management programs.14 These programs, which ensure that quality and safety standards
are upheld, are carefully managed and kept up-to-date to monitor the performance of integrated processes,
procedures, test data and automated analyzers in the laboratory. Middleware can help laboratories with their
quality management programs through the automation and integration of the following functions:

• Quality Control Results

• Moving Averages
• Integration with Quality Control Software
• Quality Assurance

Quality control (QC) helps ensure that the desired level of integrity, precision and accuracy is achieved in
patient test results.14 Middleware can enable the integration of QC data from connected analyzers, allowing
for centralized management. Automated QC solutions provided by middleware are designed to compensate
for deficiencies in a laboratory’s quality control process and reduce associated risk. For example, they
can consolidate monitoring of QC data and automatically change the analytical workflow to prevent the
automatic release of results and block new testing, in the event of a QC rule failure.

Some of the QC capabilities provided by middleware include:

• Centralized QC review for all connected instruments
• QC result comparison across different analyzers
• Westgard, RiliBÄK and user-configurable QC rules
• Graphical display of QC results to illustrate precision, accuracy and comparison
(e.g. Levey-Jennings and Youdon plots)
• Utilize rules to automatically verify or invalidate test results based on QC results

25 | Learning Guide: Middleware Use and Operation

Figure 5.1 Levey Jennings graph from Abbott’s AlinIQ Analyzer Management System (AMS). For illustrative purposes only.

PATIENT MOVING AVERAGES

An additional layer of QC management that can be assessed and managed by middleware, is the moving
average, which is also known as average of normals or running average. Moving averages is a statistical
concept that uses patient results to monitor a set of data points on a continuous basis. By doing so,
unexpected shifts in analyzer or assay performance may be detected.14 The typical process of assessing
moving averages uses a large series of numbers that are divided into overlapping subsets, with each subset
containing the same number of data points. These subsets provide the data sets for calculation of the moving
average. Middleware utilizes the data received from connected analyzers to monitor performance in real-
time with trends presented visually on a graph. Using the graph, laboratories can proactively identify trends
and detect changes in analyzer performance.

The moving averages function in some middleware solutions has the potential to offer a robust approach to
a laboratory’s QC program. In the typical setup of a middleware application, the user establishes different
protocols for test runs for a defined analyzer and then configures target means. Target means are used as
the baseline to create alerts. The flow of analyzer data into middleware allows for continuous monitoring of
moving averages trends and alerts, as well as comparison of CBC results from multiple Hematology analyzers.
These capabilities enable real-time monitoring of patient results and support the laboratory with achieving its
desired level of sample testing quality.

Middleware solutions designed with moving average capabilities enable the laboratory to more seamlessly
assess when the analyzers are performing correctly. The following are some of the benefits of middleware to
optimize laboratories’ quality management program.
• Provide alerts to operators when unexpected performance shifts occur
• Enable preemptive intervention between periodic QC testing
• Automatically disable an analyzer or assay generating QC errors
• Provide notifications based on predetermined errors and warnings

The QC program in the core laboratory requires a comprehensive management of not just the analytic process
of testing materials with a known value. A solid QC program also requires a broader view that encompasses
every task associated to testing, from test requisition to the final report.15 A comprehensive and properly
utilized middleware solution can help streamline these complex processes over the entire testing process.

26 | Learning Guide: Middleware Use and Operation

QUIZ QUESTIONS

1. Middleware can consolidate monitoring of QC test data from multiple instruments.

A True

B False

2. Which of the following are benefits of using middleware for QC management?

A Provide alerts to operators when unexpected performance shifts occur

B Enable preemptive intervention between periodic QC testing

C Automatically disable an analyzer or assay generating QC errors

D Provide notifications based on predetermined error and warnings

E All the above

27 | Learning Guide: Middleware Use and Operation

S EC TI O N 6

A N A LY ZER A ND
L A B OR ATO RY
AU TOM AT ION S YS T E M
M A N AG E MEN T
ANALYZER AND LABORATORY AUTOMATION SYSTEM MANAGEMENT . . . . . . . . 29
LABORATORY AUTOMATION SYSTEM DEFINITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
MIDDLEWARE INTEGRATION AND COMMUNICATION WITH
LABORATORY AUTOMATION SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
THE BENEFITS OF LABORATORY AUTOMATION SYSTEMS . . . . . . . . . . . . . . . . . . . . . 29

28 | Learning Guide: Middleware Use and Operation

 LEARNING 1 Define and identify the components of a Laboratory
OBJECTIVES Automation System
After completing this section, 2 Describe how middleware integrates and communicates with
you will be able to: Laboratory Automation Systems

3 Gain an understanding of the capabilities of middleware in

managing automated analyzers and Laboratory Automation
Systems

4 Recognize the benefits of Laboratory Automation Systems

ANALYZER AND L ABORATORY AUTOMATION SYSTEM MANAGEMENT

Automation is a critical part of the Core Laboratory’s operations. Given the various operational challenges
facing the laboratory, the productivity gains that automation offers through speed and efficiency are in high
demand. Holistic middleware applications can help manage analyzers and laboratory automation track
systems, automating tasks and processes.16

Middleware with robust analyzer management capabilities enables the laboratory to manage and monitor
performance of analyzer systems from a central location. For example:
• Provides readiness status and lists current work in progress of connected analyzers.
• Provides insights into connected analyzers enabling access to actionable information for
real-time management of performance.
• Enables remote access to analyzers to allow for the enabling or disabling of specific analyzers.
• Schedules maintenance tasks for laboratory equipment such as calibration, preventative
maintenance or other user-defined events per the laboratory’s or equipment manufacturer’s
standard operating procedures.

In addition to providing a wide range of analyzer management capabilities, some middleware providers
offer more comprehensive solutions that can integrate and manage Laboratory Automation Systems (LAS)
or automation track systems. A Laboratory Automation System is designed to automate pre-analytical and
post-analytical processing and sample handling, consolidating multiple analyzers and sample processing
equipment into a unified system in the clinical laboratory.16 LAS offer productivity gains through flexibility
and efficiency in sample management that can help laboratories adapt to changing demands in sample
throughput.

The implementation of a LAS with a robust middleware solution can help laboratories achieve their
operational productivity goals. Considering the total testing process, an efficient automation system offers
increased testing capacity, improved turnaround time and reduction in human error.17

Integration of a LAS, middleware and automated Hematology analyzers can help the laboratory realize
significant cost savings while enabling the staff to focus on the true exceptions and more complex tasks that
will ultimately improve the quality of patient care and lead to faster, more actionable results.

29 | Learning Guide: Middleware Use and Operation

Through central equipment management, middleware can help laboratory staff monitor and control
operations of their LAS. Some of the automation system monitoring capabilities provided by middleware
solutions may include:
• Visual indications to monitor the status of all automation modules, analyzers and assays.
• Proper routing of samples to the correct automation modules and analyzers, and the ability to perform
automated reruns, reflex and dilution testing.
• Ability to automatically enable or disable analyzers or assays.
• Provision of detailed information to the operator on sample exceptions and contents of output racks.

In addition to managing the processing of orders and returning results received from the connected
instruments through the LIS, the middleware controls the routing of tubes or samples to the various modules
of the LAS. The sample routing capability provides instructions to the LAS to determine the path a sample
must follow as it travels around the track. The routing of samples on a LAS track is managed by rules defined
in the middleware. Typically, a laboratory provides inputs to a middleware Informatics Specialist to define
routing rules consistent with the laboratory’s needs. The middleware can also handle load balancing to ensure
sample processing and testing are managed efficiently at the different modules on the track, including the
connected analyzers. A comprehensive LAS may include the following sample processing modules in addition
to the connected analytical instruments:
• Input Output Module – provides a loading and unloading point for samples using racks
• Centrifuge Module – automates centrifugation of samples
• Decapper Module – removes tube caps
• Sealer Module – seals tubes after analytical processing
• Storage and Retrieval Module – stores sample tubes in a temperature-controlled, protected
environment
• Desealer Module – removes the seal from sample tubes
• Track Module – controls the movement of sample tubes in their individual sample carriers; sample
carriers transport tubes around the track to the different modules
• Interface to connected analytical instruments – provides the path to move the tubes to the analyzer
• Aliquoter Module – generates secondary tubes from primary sample tubes

30 | Learning Guide: Middleware Use and Operation

The typical steps in the management of orders and results between the middleware and the Laboratory
Automation System include:

1. The LIS sends the order to the middleware.

2. The middleware sends the order to the LAS.
3. The LAS routes the tube to the appropriate analyzer.
4. The analyzer runs the test and sends the test to the middleware.
Note: If sample requires rerun, dilution or reflex, the middleware processes the appropriate
order messages for the analyzer.
5. The middleware sends the results to the LIS.

Orders and Sample Routing

Orders Instructions

Results Results
Sample Status Sample Status
LIS Middleware Laboratory Automation System

Figure 6.1 Communication diagram showing orders and results flow between middleware and the Laboratory Automation System

31 | Learning Guide: Middleware Use and Operation

QUIZ QUESTIONS

1. Which of the following statements are true? Middleware can:

A Monitor the performance of connected analyzers

B Schedule maintenance tasks for connected analyzers

C Manage orders and results between the LIS and LAS

D All the above

2. Where does an analyzer that is connected to a LAS sends test results?

A To the LIS

B To the middleware

C To the EMR

D To the HIS

3. Middleware provides routing information to the LAS to determine where to send sample tubes
on the track.

A True

B False

32 | Learning Guide: Middleware Use and Operation

S EC TI O N 7

REP ORT S A ND A N A LY T IC S
REPORTS AND ANALYTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
TYPES OF MIDDLEWARE REPORTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
THE VALUE OF AVAILABLE MANAGEMENT REPORTS . . . . . . . . . . . . . . . . . . . . . . . . . 34
THE KEY METRICS THAT LABORATORIES USE TO TRACK PERFORMANCE. . . . . 34

33 | Learning Guide: Middleware Use and Operation

 LEARNING 1 Distinguish between different types of middleware reports
OBJECTIVES
2 Understand the value of available management reports
After completing this section,
you will be able to: 3 Recognize some of the key metrics that laboratories use to
track performance

REPORTS AND ANALY TICS

Laboratory managers demand timely metrics to track laboratory performance and quality.18 A middleware
solution addresses this critical need by consolidating test data and providing real-time statistical reports that
help laboratories track, understand and manage their performance. Additionally, middleware can present
insights regarding the business performance of the laboratory in easy to read and understand reports.

During the processing of one patient sample, hundreds of data points may be generated. This information is
used to not only direct patient care decisions, but also to monitor the laboratory’s performance against internal
and external benchmarks. Hematology laboratories, for example, generate a tremendous volume of test results
data from automated analyzers, including CBCs. Unique aspects of Hematology are the CBC scatterplots as
well as morphological images from slide review which are linked to each patient sample. There are multiple
reporting and analytics functionality that can help the laboratories track and visualize these data.

The different reports and statistics offered by middleware can be extensive. The following is a list of some of
the popular management reports provided by middleware.
• Turnaround time (TAT) analysis – tracks the time it takes for the lab to process a patient test
request from sample receipt in the laboratory to results reported to the clinical staff. The timeliness
of laboratories to report final test results is expressed as the turnaround time, and often used as a key
effectiveness metric to measure laboratory performance.

Figure 7.1 Turnaround time (TAT) report from Abbott’s AlinIQ Analyzer Management System (AMS).
For illustrative purposes only.

34 | Learning Guide: Middleware Use and Operation

• Workload volume – counts workload trends by patients, samples and tests over a time period (hourly,
daily, weekly, monthly).

Figure 7.2 Workload report from Abbott’s AlinIQ Analyzer Management System (AMS). For illustrative purposes only.

• Analyzer utilization – tracks volumes, shifts and trends in test runs and analyzer performance.

Figure 7.3 Analyzer utilization report from Abbott’s AlinIQ Analyzer Management System (AMS). For illustrative purposes only.

With these metrics readily available, laboratories can more easily derive actionable insights from their
test results and associated activities to achieve their efficiency and performance goals.18 The automated
analytics and reports provided by middleware offer essential tools to monitor and improve quality assurance
processes. By tracking, monitoring, verifying and improving the standard of performance of all the different
processes in sample testing operations, errors can be reduced, which can invariably lead to improved staff,
test and analyzer utilization.

35 | Learning Guide: Middleware Use and Operation

QUIZ QUESTIONS

1. The metrics provided by middleware reports can help laboratories better monitor performance.
A True

B False

2. Middleware can provide reports on the following:

A Test result turnaround time (TAT)

B Volume of tests performed on a connected analyzer

C Total number of tests performed per patient

D Total number of runs for a specific test for the day

E All the above

36 | Learning Guide: Middleware Use and Operation

 A PPENDIX A ND
REFERENCES

37 | Learning Guide: Middleware Use and Operation

APPENDIX: QUIZ ANSWERS

SECTION 1 MIDDLEWARE SECTION 5 QUALIT Y MANAGEMENT

1. A 1. A
2. B 2. E
3. A -> 4; B -> 3; C -> 1; D -> 5; E -> 6;
F -> 2 SECTION 6 ANALYZER AND L ABORATORY
AUTOMATION SYSTEM MANAGEMENT
SECTION 2 TEST MANAGEMENT 1. D
1. A 2. B
2. A -> 2; B -> 3; C -> 1 3. A
3. E
SECTION 7 REPORTS AND ANALY TICS
SECTION 3 SAMPLE MANAGEMENT 1. A
1. A 2. E
2. E
3. A

SECTION 4 EXPERT DECISION RULES

1. A
2. A -> 2; B -> 1; C -> 3
3. A
4. A
5. E

38 | Learning Guide: Middleware Use and Operation

REFERENCES
1. Carter A. The Simple Definitions, Dos, and Don’ts of Installing Middleware. College of American Pathologists. 2019;
Available at: [Link]
donts-of-installing-middleware. Accessed February 10, 2020.

2. Paxton, A. Beyond Connectivity: Middleware’s Shifting Shape. Cap Today 2016; Available at: [Link]
[Link]/beyond-connectivity-middlewares-shifting-shape/. Accessed February 10, 2020.

3. Paxton, A. Broadening the Productivity Spectrum with Middleware. Cap Today 2016; Available at: [Link]
[Link]/broadening-productivity-spectrum-middleware/. Accessed February 10, 2020.

4. Strengthening the Chain of Interoperability. CLN Stat. 2019; Available at: [Link]
stat/2019/february/21/strengthening-the-chain-of-interoperability. Accessed on February 10, 2020.

5. Laboratory Information System (LIS): Definition & Functions. [Link] 2018; Available at [Link]/academy/
lesson/[Link]. Accessed February 10, 2020..

6. Giokas D. EMR, EHR and PHR – and Now aEMR and H/HIS – What’s with these Systems? Canada Health Infoway
2016; Available at: [Link]
phr-and-now-aemr-and-h-his-what-s-with-these-systems. Accessed on February 12, 2020.

7. Levy G. Use of Middleware to Increase Clinical Laboratory Efficiency. LabThruPut 2012; Available at: https://
[Link]/use-of-middleware-to-increase-clinical-laboratory-efficiency/. Accessed February 14, 2020.

8. Selmyer J and Cloutier B. Interfacing the Clinical Laboratory: A Primer for LIS Managers. Med TechNet 1996.

9. Clifford LJ. Leveraging Automation and Middleware. Elite Healthcare 2012; Available at: [Link]
resource-center/laboratory/leveraging-automation-and-middleware/. Accessed February 17, 2020.

10. Best Practices for Sample Management. FreeLims 2019; Available at: [Link]
[Link]. Accessed March 2, 2020

11. Marquardt W. AUTO15: Autoverification of Medical Laboratory Results for Specific Disciplines. In. Vol 2019. 1st
edition ed: Clinical and Laboratory Standards Institute 2019.

12. Tate A. Autovalidation: What’s your number? Medical Laboratory Observer 2011; Available at: [Link]
[Link]/home/article/13004255/autovalidation-whats-your-number. Accessed on March 5, 2020.

13. Barnes P.W. et al. The International Consensus Group for Hematology Review: Suggested Criteria for Action
Following Automated CBC and WBC Differential Analysis. Carden Jennings Publishing Co., Ltd 2005. Laboratory
Hematology 11:83-90.

14. Valenstein P. Quality Management in Clinical Laboratories: Promoting Patient Safety Through Error Reduction and
Continuous Improvement. College of American Pathologists 2005.

15. MacCormack J. Laboratory Quality Control – From Error Reduction to Risk Management. Medical Laboratory
Observer 2019; Available at: [Link]
control-from-error-detection-to-risk-management. Accessed March 6, 2020.

16. Riben M. Laboratory Automation and Middleware. Surg Pathol Clin. 2015;8(2):175-186.

17. Ching Yaur J. Automated Testing in Hematology: The Role of Rules in Setting a Standard. Medical Laboratory
Observer 2015; Available at: [Link]
testing-in-hematology-the-role-of-rules-in-setting-a-standard. Accessed March 9, 2020.

18. Ziaugra K et al. Using Analytics to manage QA and reduce laboratory errors. Medical Laboratory Observer 2019;
Available at: [Link]
qa-and-reduce-laboratory-errors. Accessed March 17, 2020.

39 | Learning Guide: Middleware Use and Operation

[Link]

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