acusera 24.7

Interlaboratory Data Management

Acusera 24.7 Live OnlineInterlaboratory data management

software

Acusera 24.7 ConnectConnectivity solution facilitating

automated import of QC data direct from LIS

Product Portfolio

Introduction to Acusera 24·7?• IQC software and peer group reporting package

– Complements the Acusera range of third party controls

– Provides a visual assessment of QC performance from multiple instruments

– Improved detection of analytical errors

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

– Increases confidence in patient test results

– Provides a measure of accuracy between EQA/PT samples

– May 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

The software has two main functions:

1. Internal Quality Control Records QC data and will help monitor analytical performance Automatically calculates statistics e.g. Mean, SD, %CV Applies QC multi-rules and alerts/rejects results based on these rules Automatically generates charts & reports for review of trends/bias

2. Peer Group Compare QC results to other labs using the same lot of control Identify whether an issue is unique to your laboratory Assists with the troubleshooting process Increases confidence in QC target values Increases confidence your lab is performing like others using the

same lot of control and instrument

Introduction to Acusera 24.7

Key Messages • Simple and intuitive user interface

– Colour coded throughout providing an instant indication of poor performance– Integrated help file to guide users through the software

• Peer data uniquely updated every 24 hrs – Generated daily from our extensive database of laboratory participants providing a real-time indication of laboratory

performance– Enhanced troubleshooting capabilities – our closest competitor updates data every 30 days – Peer group data may be based on world wide statistics or laboratory group/chain

• Online access– Software can be accessed anytime, anywhere– No need to install locally or back up data – Updates can be added to the software remotely

• Fully interactive charts– Easy to interpret and generated automatically saving precious laboratory time– Colour coded for instant identification of errors – Capable of combining multiple QC lots, assays and instruments for enhanced review of trends– Filter data to show results for a specific time frame

Key Messages • Acusera Advisor *

– Conveniently recommends an optimal QC strategy for each test enabling improved error detection– Suggests QC rules and a minimum QC frequency to reduce risk

• Unique Dashboard feature – Instantly displayed upon logging in flagging any unreviewed QC tests that have been rejected/alerted in the last 7 days – Significantly reduces the time spent analysing data providing at-a-glance performance assessment– Alerts users to control lots approaching expiry reducing risk of using expired controls

• Acusera 24.7 Connect– Optional connectivity solution designed to import QC data direct from the LIS– Significantly reduces the time spent entering data and eliminates the risk of human error– Site survey must be completed before implementation

• Flexibility – Performance limits, comments and actions can be tailored to each individual lab – Individual role based login’s – 5 levels of access; administrator, user, manager, group co-ordinator and tech support– Multi-lingual software – Suitable for use with other manufacturers controls

*Not available for use in USA

Data Entry Options

1. Automated data entry via Acusera 24.7 Connect

2. Manual data entry by test or by panel

3. Semi-automated import via EDI functionality

Dashboard

The Unique Dashboardfeature is displayed upon logging in and instantly flags any alerted or rejected results from the last 7 days

Any QC lots approaching expiry are also displayed

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

On Screen Data Review

Using the navigation tree users can switch between instruments to view data for a particular control lot or analyte

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

Levey-Jennings

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

The navigation tree allows users to add multiple parameters and instruments to the Levey-Jennings charts for advanced review of trends

By clicking or hovering over any of the points more information is displayed. For added convenience the chart is shaded for easy interpretation of performance.

Histogram

Similar to the Levey-Jennings chart users can use the top section to select the criteria they wish to display

The interactive nature means users can add multiple data sets, zoom in on a specific month/time period and show/hide data using the legend

Performance Summary Chart

Provides a visual represent-ation of a labs accuracy and precision compared to their chosen peer group

Select the date range and peer group using the filters

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

Acusera Advisor*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

Data Review

The data review report displays any unreviewed QC results that have fallen outside user-defined performance limits or broken any QC multi-rules

The report can be easily filtered to show results for a specific instrument, control lot or date

Results are colour coded orange for alert and red for reject allowing at-a-glance performance assessment. Managers can review data and enter corrective actions.

Statistical Analysis Report

Provides a complete overview of performance for any given month. Individual laboratory data can be compared to worldwide peer group statistics for advanced data review and trouble-shooting

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

Peer Group Statistics (World)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 of lab group/chain

Peer data is uniquely updated every 24 hrs providing access to the most up to date info for advanced trouble-shooting capabilities

Peer Group Statistics (Siemens)

In this example we can see peer group stats for a chemistry lot on the Siemens Dimension RXL


In this example we can see peer group stats for a chemistry lot on the Siemens Advia 1800


In this example we can see peer group stats for an immunoassay lot on the Siemens Advia Centaur


In this example we can see peer group stats for an immunoassay lot on the Siemens Immulite 2000

Audit Trail ReportThe 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

The End

acusera 24.7

Health & Medicine