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Quality Management: Section 5

Middleware can help laboratories manage their quality control programs through automating functions like quality control results, moving averages, and integration with quality control software. It allows for centralized management of quality control data from multiple connected analyzers. Middleware provides automated quality control solutions that monitor quality control data, detect issues, and prevent release of invalid results. These solutions offer benefits like real-time monitoring of performance and preemptive intervention to ensure testing quality standards are met.

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67 views

Quality Management: Section 5

Middleware can help laboratories manage their quality control programs through automating functions like quality control results, moving averages, and integration with quality control software. It allows for centralized management of quality control data from multiple connected analyzers. Middleware provides automated quality control solutions that monitor quality control data, detect issues, and prevent release of invalid results. These solutions offer benefits like real-time monitoring of performance and preemptive intervention to ensure testing quality standards are met.

Uploaded by

Iberis
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SECTION 5

QUALITY
MANAGEMENT
LEARNING OBJECTIVES

When you complete this section, you will be able to:

• Define Quality Control

• Define Moving Averages

• Understand the utilization of automated quality management solutions provided by middleware

• Recognize some of the benefits of quality management middleware functions

23 LEARNING GUIDE: MIDDLEWARE USE & OPERATION


SECTION 5 – QUALITY 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

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

LEARNING GUIDE: MIDDLEWARE USE & OPERATION 24


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. The
moving average 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 average 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.

Now complete the section Quiz.

25 LEARNING GUIDE: MIDDLEWARE USE & OPERATION

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