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A Detailed Look at How Modern Laboratory Information Systems Fully Support Quality Control
December 19, 2024
Spend time in a modern medical lab and one thing becomes abundantly clear very quickly: the critical importance of Quality Control (QC). It’s a foundational requirement for modern clinical labs and pathology groups, underpinning their ability to deliver accurate, reliable, and timely results to providers and patients.
Fortunately, the critical importance of quality control is also fully understood by modern laboratory information system vendors who continue to engineer advanced LIS system software capable of supporting and managing the latest and most advanced QC protocols.
Learn More: Best LIS Software - Maximize Growth With Cutting-Edge Pathology Lab Management Software
This blog post will highlight the importance of QC protocols such as the Levey-Jennings Chart and the Westgard Rules and examine how modern laboratory information system software technology fully supports them. After that, we’ll look at LigoLab’s Quality Control module (available in the Professional Tier) and explore how it systematically tracks, monitors, and analyzes various aspects of lab workflow, ensuring consistent delivery of accurate, reliable, and timely test results.
How the Levey-Jennings Chart and the Westgard Rules Came to Be
The Levey-Jennings Chart is a visual graph that plots quality control data and shows how results deviate from the mean (the average value of a set of repeated measurements or control results). The chart makes it easier to assess whether an analytical system is functioning properly.
The L-J chart dates back to 1950 and is named after Dr. Stanley Levey and Dr. E.R Jennings, two pathologists who first recognized that Shewhart’s individuals control chart could be used effectively in a clinical lab setting.
The Westgard Rules, named after Dr. James Westgard, are statistical quality control rules that date back to the 1970s and provide a structured way to determine when laboratory test results may be inaccurate due to random errors or systematic problems. Think of them as a set of checks that help clinical labs ensure test result accuracy, thereby maintaining quality and patient safety. They allow for early detection of potential issues, prompt corrective action, and prevention of inaccurate results being reported.
Editor’s Note: Click HERE for more detailed descriptions of the Levey-Jennings Chart and the Westgard Rules.
The Benefits of Comprehensive Lab QC Tools and Practices
The Levey-Jennings Chart and the Westgard Rules are essential to laboratory quality control because they establish an overlapping and systematic approach to identifying errors in lab testing processes long before they impact patient results.
Here’s a summary of how they work together to create a comprehensive lab QC workflow.
How the Levey-Jennings Chart and the Westgard Rules Work Together
- Visual Representation + Statistical Rules: The Levey-Jennings Chart gives users a clear visual representation of QC performance over time, while the Westgard Rules provide the statistical judgment to interpret deviations meaningfully.
- Early Error Detection: Together, these QC tools allow the clinical lab to identify errors early, whether random (like equipment malfunction) or systematic (like reagent degradation), preventing erroneous results from being reported.
- Prevention of False Rejections: The Westgard Rules and the Levey-Jennings Chart reduce the risk of unnecessary rejections of results, ensuring that only significant deviations trigger alarms, leading to more efficient QC processes.
- Consistent Performance Monitoring: This combination ensures ongoing, real-time tracking of lab test performance, helping labs maintain high standards and prevent problems before they affect patient results.
- Compliance with Regulations: Both tools help labs meet the quality control standards required by regulatory bodies and accrediting agencies, ensuring compliance and proper documentation.
Best Practices and Tools for Maintaining High QC Standards
In addition to using the Levey-Jennings Chart and the Westgard Rules, clinical laboratories can proactively improve quality control by implementing a variety of best practices, including the following:
Regular Calibration and Maintenance of Equipment - Regular calibration and maintenance are essential for ensuring accurate results and reducing the risk of malfunctions. Calibration aligns instruments with standard values, while maintenance keeps them functioning optimally, helping to minimize errors in test results.
Internal Quality Control (IQC) Programs - IQC programs involve running control materials, which provide an ongoing measure of accuracy and help identify potential issues early on.
External Quality Assessment (EQA) / Proficiency Testing - By participating in EQA programs, laboratories compare their test results against those of other labs, providing an external measure of accuracy. If performance falls short, corrective actions can be taken to improve methods and maintain consistency. EQA programs thus help ensure that laboratories remain in line with industry standards and can consistently provide reliable patient results.
Standard Operating Procedures (SOPs) - These document all aspects of testing, quality control, and troubleshooting, which helps ensure that all personnel follow the same protocols.
Staff Training and Competency Assessment - Regular training and competency assessments further contribute to quality control by ensuring that staff is up-to-date with current best practices, techniques, and regulatory requirements. Competency checks help verify that laboratory staff have the skills to perform their duties accurately and efficiently.
Data Management Systems - Laboratory information systems (LIS systems) and laboratory information management systems (lab LIMS) play a key role in tracking samples and managing quality control data with advanced systems able to automate data collection, making it easier to monitor trends and analyze QC data. This allows labs to identify and address potential problems. Additionally, electronic QC logs within these laboratory software systems improve data storage, trend identification, and organization, ensuring efficient quality control management.
Root cause analysis, method validation, statistical quality control software, and reagent management are other important components of quality control in the lab. Root cause analysis helps identify the underlying cause of QC failures so that corrective and preventive measures can be placed. Validation of new test methods ensures they meet performance standards, while quality control software helps labs monitor real-time data. Proper management of reagents and supplies is also essential for minimizing errors.
Clinical laboratories can achieve even greater reliability and consistency in their testing processes by incorporating these additional quality control measures in correlation with the Levey-Jennings Chart and the Westgard Rules.
How Advanced Laboratory Information System Software Supports Lab QC
Modern laboratory information systems (LIS system software) were briefly referenced earlier in this blog, so let’s next look at detailed examples of how the best LIS software supports the highest levels of lab QC.
One of the main ways advanced LIS systems support quality control is through automated tracking of QC data. By directly collecting and recording quality control results from laboratory instruments, these LIS systems reduce the risk of manual errors and improve the accuracy of data management. This automation also frees up time for lab personnel, allowing them to focus more on analyzing results and less on manual data entry.
Another significant feature of modern LIS systems is real-time monitoring and alerting. The best LIS software can be configured to notify laboratory personnel immediately if quality control results fall outside of acceptable limits or if a Westgard rule violation occurs. These real-time alerts enable prompt investigation and corrective action, preventing the release of potentially inaccurate patient results. This proactive approach to quality control helps ensure that any issues are identified and resolved quickly, safeguarding the reliability of patient testing.
As touched on earlier, modern laboratory information system software also includes built-in tools for statistical quality control (SQC) analysis (such as generating the Levey-Jennings Chart and applying the Westgard Rules) and performing trend analysis. These features allow laboratory staff to assess QC data systematically and identify issues such as shifts or trends that may indicate underlying problems. The ability to visualize QC data through charts and graphs makes it easier to spot inconsistencies, ensuring that laboratory tests remain accurate and reliable.
Document management and integration of standard operating procedures (SOPs) are further ways in which the best LIS software enhances quality control. SOPs can be stored within the LIS system, allowing staff easy access to procedures and protocols. This promotes consistency in laboratory operations, as personnel can follow standardized workflows directly from the medical LIS. Additionally, the LIS lab software can store calibration records, QC logs, and other important documentation, simplifying compliance with regulatory standards and audit requirements.
Participating in External Quality Assessment (EQA) programs is crucial for maintaining laboratory accuracy, and LIS systems make it easier to manage this process. LIS systems can store EQA results, generate comparison reports, and monitor the lab’s performance against other laboratories. By centralizing EQA management, advanced LIS software solutions help laboratories identify areas for improvement and ensure that they consistently meet external quality standards.
Trend analysis and historical data review are other key benefits provided by modern pathology LIS systems, enabling users to store and analyze historical QC data to detect long-term trends, monitor instrument stability, and evaluate reagent performance. By analyzing these trends, laboratories can identify gradual changes and take preventive measures before problems escalate. This long-term monitoring capability, combined with other features such as instrument calibration alerts and audit trails for compliance, makes advanced LIS systems indispensable for ensuring high-quality control standards in clinical laboratories.
Learn More: Essential Anatomic Pathology LIS Software Features to Optimize Laboratory Workflow
A Closer Look at LigoLab’s Powerful and Comprehensive Quality Control Module
As a leading provider of advanced pathology lab software (such as LIS systems, laboratory billing solutions, and direct-to-consumer lab testing portals) for two decades, LigoLab has gained a well-earned reputation for enabling its lab partners to modernize operations.
LigoLab’s Quality Control module serves as a great example of this because it doesn’t just track a lab's performance - it actively enhances it by systematically monitoring, analyzing, and optimizing various workflow aspects and ensuring consistent delivery of precise and trustworthy results.
At its core, LigoLab’s QC module empowers users to set up tailored QC rules for each test and monitor real-time outcomes. It goes beyond basic metrics by incorporating Allowable Total Error (ATE) and Biological Variance. ATE captures analytical and preanalytical errors, giving labs a more comprehensive view of their overall performance. Biological Variance accounts for natural fluctuations in patient results, adding depth to a lab’s performance assessments.
The QC module truly excels when handling large volumes of complex clinical tests. It minimizes errors and boosts efficiency by leveraging industry-standard methods while ensuring a thorough analysis of testing processes and providing actionable insights to refine a lab's testing accuracy.
Seamlessly integrated with other LigoLab modules, The QC module offers unparalleled transparency through the entire lab workflow. It seamlessly integrates with all other modules within the LigoLab LIS & RCM Laboratory Informatics Platform and flags problematic samples early in the preanalytical phase highlighting potential errors during analysis, ensuring nothing slips through the cracks.
Learn More: Why Integrated LIS System and Lab RCM Software is a Catalyst for Growth
On the compliance front, LigoLab's QC module simplifies the often daunting process of meeting regulatory requirements. It effortlessly generates detailed, audit-ready reports that satisfy CAP, CLIA, and other agency standards. Plus, all QC data is securely archived for easy access during inspections.
In essence, LigoLab's QC module is more than just a pathology software tool - it's a strategic asset that elevates a lab’s quality, streamlines efficiency, and ensures full compliance.
Ready to Learn More?
We invite you to learn more about the QC module (bundled into the Professional Pricing Tier) and LigoLab’s commitment to innovation by contacting a knowledgeable LIS system product specialist.
