Interlaboratory Data Management – July 2019
Interlaboratory Data Management – July 2019
Acusera 24•7 Live Online is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities, Acusera 24•7 Live Online will help to meet regulatory requirements, improve error detection, reduce false rejections and ensure accurate patient results.
Delivering an online platform for effective QC data management, our software provides unique access to instantly updated real-time peer group data, automatically generated QC statistics, QC multi-rules, interactive charts and comprehensive reports.
‘The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the quality control rules are violated and indicate that examination results are likely to contain significant errors the results shall be rejected… Quality Control data shall be reviewed at regular intervals to detect trends in examination performance’.
ISO 15189:2012
Why implement an interlaboratory program?
Acusera 24•7 Live Online is an essential QC tool for laboratories of all sizes. By participating and implementing our software your laboratory will be able to do the following;
- Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
- Automatically calculate Measurement Uncertainty, Total Error and Sigma Metrics
- Bridge the gap between daily quality control and external quality assessment
- Improve EQA performance by eliminating any undetected bias
- Facilitate regulatory compliance
- Minimise false rejections through the use of QC multi-rules
- Increase confidence in assigned QC target values
- Speed up troubleshooting processes, shortening delays in reporting
Acusera 24•7 key features and benefits
Peer group statistics are now uniquely updated live in real-time ensuring immediate access to the most up to date information available while ultimately reducing time and money spent troubleshooting, re-running samples and performing instrument maintenance. Peer groups may be based on worldwide statistics or an affiliate group of laboratories meaning you can instantly discover how you compare to other laboratories using the same lot of QC and identify if issues are unique to your laboratory or a widespread problem.
Available at no extra cost the unique dashboard allows instant identification of any QC failures and from the last seven days. Designed to significantly reduce the time spent analysing data, this highly convenient and user-friendly function means corrective action can be taken immediately with minimum disruption to the laboratory’s output. Alerts are also provided when a control lot is reaching expiry, reducing the risk of using expired material.
Levey-Jennings, Histogram and Performance Summary Charts are generated on demand, delivering quick and easy performance monitoring. With Acusera 24•7 Live Online, users have the ability to add multiple instruments, parameters and lots to a single chart allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.
The user-friendly interface and interactive nature of the chart allows you to view data for a specific date range, zoom in on a specific data point, comment on individual data points and record events including calibration and reagent lot changes for enhanced review of trends.
Our software now automatically calculates %Bias, Total Error and Sigma metrics, enabling enhanced performance assessment and improved QC strategy design for your laboratory. The added benefit of Uncertainty of Measurement (UM) helps to meet ISO 15189 requirements. In addition results may be rejected or alerted based on QC multi-rules or user defined performance limits including Rilibak, CLIA and biological variation.
The Acusera Advisor tool will conveniently recommend a set of QC multi-rules and a minimum QC frequency for each assay based on previous performance history. Tailoring QC multi-rules to each assay in this way will make QC processes more efficient whilst ensuring high error detection rates.
Designed to help speed up the review process a range of comprehensive reports are available including, Statistical Metrics Reports, Uncertainty of Measurement Report, Exception Report, and the Audit Trail Report which provides a secure, electronic record of the creation, modification and deletion of data. This effective method of documenting the review process can help laboratories meet regulatory requirements and gain accreditation.
Evaluate and review any poor performing QC tests
The Data Review report displays data for all QC tests which have fallen outside your laboratory’s user-defined performance limits. Data may be filtered by date, instrument, lot number or rule violation. It may also be filtered to display only alerted/rejected results. The report can be exported or printed easily, to document the review process.
As always, results are colour-coded for added convenience. Once results have been evaluated, managers can record their actions by marking each result as ‘reviewed’. A ‘reviewed’ result will no longer appear on the Dashboard.
Our fully automated connectivity solution is designed to meet the needs of all laboratory types and sizes. QC data can be quickly and efficiently imported from LIMS to Acusera 24•7 Live Online without the need to import files or manually enter data.
- Reduce workload by eliminating issues associated with manual data entry
- Increases productivity and efficiency
- Captures and imports only QC data
- Secure real-time connection without disruption to the laboratory
- The software is also capable of bi-directional communication with LIMS
What is Six Sigma?
Six Sigma is a method of process improvement which focuses on minimizing variability in process outputs. The Six Sigma model was developed by Motorola in 1986, and Motorola have reportedly saved over $17 Billion due to its successful implementation.
The model looks at the number of standard deviations (SD) or ‘sigmas’ that fit within the quality specifications of the process. In the laboratory, the quality specifications relate to the Total Allowable Error (TEa). The higher the number of standard deviations that fit between these limits, the higher the sigma score and the more robust the process or method is. As sources of error or variation are removed from a process, the SD becomes smaller and therefore the number of deviations that can fit between the allowable limits is greater; ultimately resulting in a higher sigma score.
A process with a sigma score of six is considered to be a high quality process, making six the target for many industries including the clinical laboratory.
In order to achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. In a Laboratory context, this would equate to 3.4 failed QC results per million QC runs.
Sigma is calculated using the following equation:
Sigma = (TEa – %Bias) / %CV
TEa – Total Allowable Error
%Bias – Deviation from the target or peer group mean
%CV – Imprecision of the data
Why is Six Sigma useful in the laboratory?
Six Sigma can be used to help answer one of the most commonly asked questions in laboratory quality control. How often should I run QC?
The Six Sigma model allows laboratories to evaluate the effectiveness of their current QC processes. Its most common use is to help implement a risk-based approach to QC, where an optimum QC frequency and multi-rule procedure can be based on the sigma score of the test in question. The performance of tests or methods with a high sigma score of six or more may be evaluated with one QC run (of each level) and a single 1:3s warning rule. On the other hand, tests or methods with a lower sigma score should be evaluated more frequently with multiple levels of QC and a multi-rule strategy designed to increase identification of errors and reduce false rejections.
The below table shows how multi-rules and QC frequency can be applied according to Sigma Metrics:
| Sigma Score | QC Frequency | Number of QC Samples | QC Rules |
| 6 or more | Once per day | Each level of QC | 1:3s |
| 5 | Once per day | Each level of QC | Multi-rule strategy |
| 4 | At least twice per day | Each level of QC | Multi-rule strategy |
| < 4 | At least four times per day | Each level of QC | Multi-rule strategy |
It is important to note that this is just an example and it may be necessary to run QC samples more often than three times per day. Some high throughput laboratories prefer to run QC samples before and after a set number of patient samples, while others opt to run QC samples after a set period of time. Whatever frequency you choose it is vital that the frequency is appropriate for the test in use. Download our guide ‘How often is right for QC’ to find out more.
What can Randox offer?
Randox’s Acusera 24.7 Live Online is a peer group reporting software application designed to complement the Acusera QC range. The intuitive and user-friendly software boasts some of the most advanced features on the market, and Version 1.6 provides automatic calculation of sigma scores for individual assays, giving the user an at-a-glance overview of assay performance.
Peer group reporting software is an integral part of any modern laboratory seeking to streamline their QC processes and reduce costs. With Acusera 24.7 Live Online, there has never been a better time to implement, save and succeed.
Contact us today to find out how Randox can help your laboratory achieve its goals.
