Interlaboratory Data Management

Acusera 24•7 Live OnlineInterlaboratory data management

software

Acusera 24•7 ConnectConnectivity solution facilitating

automated import of QC data direct from LIMS

Product Portfolio

Introduction to Acusera 24•7 ?• Cloud based IQC software and peer group reporting package for smarter QC data management

– Provides a platform to track and analyse daily QC results

– Allows real-time comparison of results with laboratories worldwide

– Provides a visual assessment of IQC performance from multiple instruments

– Manage multiple sites and instruments on one centralised platform

– On-demand reports available at the touch of the button

– Sigma metrics and Uncertainty of Measurement automatically calculated

– Complements the Acusera range of third party controls however can be used with other manufacturers controls ensuring one platform for all your QC products

Introduction to Acusera 24•7 ?• Ultimately Acusera 24•7 will

– Speed up the review process

– Improve error detection and help identify trends

– Facilitate faster troubleshooting

– Reduce false rejections and unnecessary repeat tests via QC multi-rules

– Increase confidence in patient test results

– Increase confidence in assigned target values

– Provide a measure of accuracy between EQA/PT samples

– Help meet regulatory requirements

Regulatory Requirements

“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure,

When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the

results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”

ISO 15189:2012

Software Overview The software’s functionality can be split into the following categories; Internal Data Management and Peer Group Comparison.

Internal Peer Comparison Internal Performance Review • Interactive Levey-Jennings• Interactive Histogram• Result History • Dashboard • QC Multi-Rules• Exception Report • Performance Limits (RIQAS, CLIA,

BV, RiliBAK)Performance Indicators• % Bias• CVI• SDI• Sigma Metrics• Uncertainty of Measurement • Total Error

Utilities • Audit Trail• Acusera Advisor • Bi-directional Activity

Peer Data Comparison• Performance Summary

Charts• Statistical Analysis Report • Statistical Metrics Reports • Peer Group Statistics

BenefitsPeer group stats updated live in real-time• Identify trends and shifts sooner • Faster troubleshooting capabilities • Instantly discover how you compare to other labs

using the same lot of QC• Identify if issues are unique to your laboratory or

a widespread problem• No submission deadlines for QC data • Compare with labs around the world or just your

affiliated network

Advanced statistical analysis • Automatic calculation of sigma score, %Bias,

Total Error and other performance indicators enabling enhanced performance assessment and QC strategy design

• Capable of uniquely calculating Measurement Uncertainty thus helping to meet ISO 15189 requirements

“Randox presents their answer to What is Six Sigma? Now they include Sigma-metric scores as part of their Acusera 24.7 Live Online software. Automating the Sigma-metric calculation

helps increase the ease of implementation of this

approach. Kudos for Randox for including it in their software.”

Sten Westgard

Benefits

Unique Dashboard interface • Instantly flags any rejected or alerted results

from the last 7 days, reducing the time spent analysing QC data

• Alerts you to control lots approaching expiry eliminating the risk of using expired material

• New sync service notifies users when data has been successfully uploaded via EDI or Connect

Fully interactive charts • Levey-Jennings, Histogram and Performance

Summary Charts are generated on-demand for quick and easy performance monitoring

• Add multiple tests, instruments and QC lots to a single chart for comparative performance assessment and better identification of trends

• Add events such as instrument service to Levey-Jennings charts

BenefitsConnectivity • Connects direct to LIMS for automated data entry

thus increasing productivity and eliminating issues associated with manual data entry

• Capable of bi-directional communication with LIMS. Receive alerts if a QC multi-rule is triggeredComprehensive reports

• Speed up the review process with easy-to-read, on-demand reports

• Customise to show data for a user-defined date range

• Print directly or export to pdf/excel Highly flexible to meet individual laboratory needs• May be used with other manufacturers QC• Multi-lingual capabilities • Custom configuration of performance limits,

multi-rules, peer group and target values for each instrument and lot

• Individual role based user accounts with custom access to ensure access to only required information

BenefitsSimple and intuitive interface • The new-look software is faster and more

powerful delivering an enhanced user experience • Colour coded throughout, providing an instant

visual indication of performance • Simple assay configuration with ability to share a

configuration across multiple sites and instruments

Online access • Cloud based software eliminating the need for

local installation and frequent back ups• Automatically receive future updates to the

software

Benefits

Multiple lab management • Real-time comparison of results within your

affiliated network or global peer data

Technical Support • Expert technical support available• Remote access enables immediate

troubleshooting without the need for on-site assistance

World class controls • World leading controls offering unrivalled

commutability, consolidation, stability and consistency

Dashboard – Rapid identification of QC failures

Available at no extra cost the Dashboard instantly flags any alerted or rejected results from the last 7 days reducing the time spent analysing data and allows immediate action to be taken.

Any QC lots approaching expiry are also displayed along with the number of results successfully entered via EDI or Connect.

Colour coded red for reject providing an instant visual indication of performance

Result History – Visual overview of QC history

Displays all QC results entered for a particular test.

The software automatically calculates monthly and cumulative statistics for each lot of control.

Results are rejected/alerted based on user defined performance limits or multi-rules. Results are colour coded orange for alert and red for reject providing a quick visual overview of performance

Results may be filtered to display rule violations or rejected/alerted results for a particular instrument or QC lot.

Add comments and manually accept/reject results to speed up the review process.

Levey-Jennings – Identify trends, bias and precision problems

Using the area above the chart users can select the criteria they wish to base the chart on e.g. date range, SD/%Dev and number of levels

Display individual daily QC results for a selected date range. View multiple parameters, lots, instruments and events on a single Levey-Jennings chart for advanced review of trends.

By clicking or hovering over any of the points more information is displayed. Any alerted results are highlighted in orange and rejected results in red.

Histogram – Rapidly identify test system bias

Add multiple instruments, analytes and QC lots to a single chart for comparative performance assessment, easy identification of trends and faster trouble-shooting

Performance Summary Chart – compare performance to chosen peer group

Provides a graphical represent-ation of individual lab perfor-mance compared to chosen peer group

Data can be displayed for a custom date range

The chart is colour coded for at-a-glance assessment

Statistical Analysis Report – compare performance to worldwide peer data

Provides a complete overview of performance for any given time period. Individual laboratory data for each test is compared to worldwide or affiliate group statistics for advanced data review and trouble-shooting

All reports can be easily printed or exported to PDF or excel file.

Using the cog icon the report can be grouped by instrument, assay or lot

Statistical Metrics Report – displays performance metrics including sigma

Incorporates several new metrics including; %Bias,Total Error (TE) and Sigma. See which tests are performing the best with automatics calculation of a sigma sore.

Measurement of Uncertainty Report – Meet ISO 15189 requirements

This new report displays the MeasurementUncertainty (UM) of all QC tests currently in use helping you to easilymeet ISO 15189:2012 requirements.

To calculate UM, users must first enter the SEM of the intra assay precision for each test and each level of control. Based on performance history, the software will then automatically calculate the SD of the inter assay Precision.

Exception Report - View assays with a high degree of errors

The new exception report provides an on screen summary ofthe number of QC results for each individual assay and control lot thatfall within the following categories <2SD, 2-3SD and >3SD..

Peer Group Statistics – Access true real-time peer group statistics

The peer group statistics report can be filtered to show peer group data for a specific test or system. Peer data may be based on world wide statistics or lab group/chain

Peer data is uniquely updated live in real-time providing access to the most up to date info for advanced trouble-shooting capabilities

Acusera Advisor* - recommends QC rules and optimal QC frequency

Convenient tool designed to help users select QC multi-rules for each test in use. The software will also suggest a minimum QC frequency

Suggestions are based on normalised OPSpec charts. Suggestions can be made once a minimum of 20 results for at least two levels of control have been entered and performance limits have been set.

I – Inactive R – Reject A – Alert *Not available for use in USA

Audit Trail Report – overview of historical actions

The audit trail records all actions relating to the creation, modification or deletion of a record and is ideal for regulatory purposes.

The report can be filtered using the drop down menus to display exactly what the user wants to show

Data Entry Options – Automated • Automatically capture data directly from

your LIMS with Acusera 24•7 Connect and import to Acusera 24•7 Live Online without the need to manually import files– Reduced workload as no need to manually

enter data or import files– Eliminate transcription errors

• Benefit from bi-directional communication– Receive alerts when QC multi-rules are

triggered

• Our Acusera 24•7 Connect team will work directly with you and your IT team to implement the best solution for your lab’s requirements.

1. Acusera 24•7 Connect securely collects and processes QC data directly from the LIS/LIMS for import into Acusera 24•7 Live Online

Data Entry Options – EDI

• EDI is the ideal solution for laboratories that don’t want the hassle of manual data import but still want to benefit from a reduction in time and elimination of transcription errors.

Data Entry Options - Manual

• Easily create custom panels for faster result entry of multiple tests at once, with the option to enter single or summarised for each test or panel.

The End