AlinIQ AMS Guide
AlinIQ AMS Guide
AlinIQ AMS Guide
MIDDLEWARE
USE AND
OPERATION
corelaborator y.abbott/hematology
1 | Learning Guide: Middleware Use and Operation
CON T EN T S
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SECTION 1
MIDDLEWARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
SECTION 2
TEST MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SECTION 3
SAMPLE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
SECTION 4
EXPERT DECISION RULES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
SECTION 5
QUALIT Y MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
SECTION 6
ANALYZER AND L ABORATORY AUTOMATION
SYSTEM MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
SECTION 7
REPORTS AND ANALY TICS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
APPENDIX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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.
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 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.
MIDDL E WA RE
What is Middleware?
Middleware capabilities
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
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.
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.
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.
OUTPATIENTS OR
Or DE
RS
der
Outpatients s
RE
EMR Re
SU
LT S
sults
ORDERS ORDERS
EMR Orders Orders
RESULTS RESULTS
RS
DE
s OR Results Results
der
Or S UL
TS
LIS Middleware Instruments
INPATIENTS RE LIS MIDDLEWARE INSTRUMENT
su lts
Re
Inpatients HIS
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.
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:
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
6. REPORTS
- Track and summarize data from connected analyzers
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 Automates the analysis of patient test orders and results _____ 1. Expert Decision Rules
D Track and summarize data from connected analyzers _____ 4. Test Management
F Manages sample workflow, logistics, and archiving to optimize 6. Analyzer and Automation
sample processing _____ Management
T ES T M A N AG E MEN T
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:
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:
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:
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.
1. The test management feature coordinates the tasks required to translate test orders to patient
results.
A True
B False
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
S A MPL E M A N AG E MEN T
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.
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
A Misidentification of samples
B Inaccurate testing
C Incomplete testing
3. The ability to track the location of a sample is considered a sample logistics middleware capability.
A True
B 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.
Compare with
previous; release Is this
if within YES a rerun?
acceptable limits
NO
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?
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.
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
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
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
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.
Advanced rules solutions are typically customizable and can be adapted and revised as the workflow of the
laboratory evolves.
1. Rules are logic statements that take the form: IF some condition is TRUE, THEN perform a
certain ACTION
A True
B 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.
QUA L I T Y M A N AG E MEN T
Quality management
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 (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.
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.
A True
B False
A N A LY ZER A ND
L A B O R ATORY AU TOM AT ION
S YS T E M M A N AG E MEN T
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
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
ResultsResults Results
Results
SampleSample
Status status Sample
SampleStatus
status
LIS Middleware Laboratory
Automation System
LIS MIDDLEWARE L ABORATORY
AUTOMATION
Figure 6.1 Communication diagram showing orders and results flow between middleware and the Laboratory Automation
System
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
REP ORT S A ND A N A LY T IC S
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.
33 | 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.
1. The metrics provided by middleware reports can help laboratories better monitor performance.
A True
B False
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
1. A
2. A -> 2; B -> 1; C -> 3
3. A
4. A
5. E
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of companies or their respective owners.