QUALITY CONTROL

Q
24•7

Q 24 7

Interlaboratory Data
Management

Complete QC solutions for results you can trust

Why Participate in Acusera 24•7?

An Effective Tool For Evaluating Laboratory Performance

Acusera 24•7 is an interlaboratory data management package, primarily designed to complement the Acusera range
of true third party controls.

An effective IQC and peer group reporting program like Acusera 24•7 will help to improve your laboratory’s
analytical performance, meet regulatory requirements and most importantly, ensure accurate results.

The software has two complementary functions; the internal function of the software is designed to help laboratories
manage and interpret their daily QC data while the peer group function of the software allows comparison to
worldwide peer group statistics, enabling rapid and effective troubleshooting.

Identify any trends, system errors or reagent issues Have confidence in assigned target values
Acusera 24•7 will allow users to immediately detect and identify Together with data from RIQAS, the world’s largest international
errors in their laboratory test system. EQA scheme, Acusera 24•7 provides immediate confidence in
assigned target values.
Access to comprehensive charts and peer group data allows
users to identify problems that may otherwise have gone Facilitate regulatory requirements
unnoticed and assess if shifts in QC recovery are unique to their Participation in an interlaboratory or peer group reporting
laboratory. Access to peer group data may even alert lab staff program is becoming compulsory in countries worldwide.
to future issues before they are encountered in their laboratory.
IS015189:2012 states that:
Minimise false rejections using QC multi-rules “The laboratory shall have a procedure to prevent
The ability to apply user-defined QC multi-rules will help to the release of patient results in the event of quality
reduce false rejections and the number of repeat tests whilst
control failure. When the quality control rules are
violated and indicate that examination results are
maintaining a high level of error detection. The new Acusera likely to contain clinically significant errors, the
Advisor tool will recommend QC multi-rules and a minimum results shall be rejected.... Quality Control data shall
QC frequency based on method performance. be reviewed at regular intervals to detect trends in
examination performance.”
Bridge the gap between IQC and EQA
Acusera 24•7 is designed to complement your current EQA Get an independent perspective
scheme, providing users with added confidence in-between Dedicated controls supplied by the instrument manufacturer
samples. can mask weaknesses within a test system, increasing the risk
that a shift in patient results will go unnoticed.
EQA is performed retrospectively therefore, acceptable EQA
performance at the time of analysis does not guarantee the The combination of Randox third party quality controls and
accuracy and reliability of laboratory testing. Acusera 24•7 can reduce the potential for bias and provide a
true assessment of analytical performance.
Participation in an effective interlaboratory program like
Acusera 24•7 is essential in order to ensure the accuracy and
reliability of patient test results. It may even help to improve
EQA performance.

1
 Acusera 24•7 Live Online Summary

Online access anytime, anywhere Real-time peer group data

• Eliminates the need for local installation and frequent back ups, • Peer group statistics are uniquely generated every 24 hours
making it suitable for laboratory groups and chains. from our extensive database of laboratory participants.
• Convenient and easy to use.
Comprehensive reports
Optional automated QC data import via Acusera 24•7 •
A range of comprehensive reports are available, helping
Connect laboratories to monitor performance and meet regulatory
• Capable of connecting directly to your laboratory’s LIS or requirements.
Middleware.
• Increases productivity and eliminates problems associated with Highly flexible to meet individual laboratory needs
manual data entry. • Multi-lingual software.
• Although intended for use with the Acusera control range,
Simple and intuitive user interface the software’s internal functions may be used with any QC
• The software is colour-coded throughout, enabling an instant material.
visual indication of poor performance.
• The built-in help file is divided into user-friendly sections that help Dashboard
to guide the user through the software. • The unique Dashboard instantly flags any rejected or
alerted results and warns users when QC lots are approaching
Fully interactive charts expiry.
• Levey-Jennings, Histogram and Performance Summary Charts
are automatically generated, enabling identification of trends
or bias.

2
Dashboard Interface

The unique Dashboard interface provides a rapid indication of poor performance

The unique Dashboard interface is available at no extra cost to The date, instrument, analyte, lot number, result, , SD, SDI and rule
laboratories. It is automatically displayed and updated every minute, violation are displayed. Results are colour-coded red for reject and
instantly bringing all unreviewed, alerted or rejected QC results from orange for alert. QC results are alerted or rejected based on the user-
the last seven days to the user’s attention. This highly convenient and defined or Acusera Advisor recommended QC multi-rules.
user-friendly function allows quick and easy identification of any poor
performing tests that require further investigation. It also alerts users
when a control lot is reaching its expiry date.

3
 Data Entry

Provides users with a visual overview of current analytical performance

The data entry function is used to manually enter QC data, but also Results are colour-coded so that those outside selected acceptable
provides an on-screen summary of all QC data entered to date. limits of performance are highlighted in orange for ‘alert’ and red when
Acusera 24•7 will automatically calculate statistical data, including the ‘rejected’, thus allowing for quick and easy identification. The system
and SD. Data is presented in a user-friendly format, allowing any sudden also indicates which rule has been violated. Users may add comments
or gradual changes in performance to be identified immediately. or actions, enabling advanced data review.

The summary provides a breakdown of monthly and cumulative data

for up to three lots of control and enables comparison to a user-defined
Fixed Mean and SD.

4
Acusera Advisor

Automatically recommends QC multi-rules and optimal QC frequency

Acusera Advisor* is an optional tool designed to help laboratories Recommendations are based on normalised OPSpec charts. Once
select an optimum QC strategy for each individual test in use. Not performance limits have been defined, the software will determine
only will the advisor tool recommend a set of QC multi-rules, it will the %CV and %Bias. These are then used to calculate the normalised
also suggest a minimum QC frequency based on the performance of operating point. A normalised OPSpec chart is then used to select the
the method in question. The use of QC multi-rules will reduce false appropriate QC strategy.
rejections, unnecessary troubleshooting and the need for costly repeat
tests without affecting error detection.

Before any recommendations can be made for a particular method,

users must enter a minimum of 20 results for at least two levels of
control and set user-defined performance limits.
*
Not available in USA
5
 Acusera Advisor Report

Displays a suggested QC frequency and Analytical Quality Assurance for each assay

The Acusera Advisor* report is easily generated and provides a list of all The report can be generated for each individual instrument or for all
assays along with the Analytical Quality Assurance (AQA) achieved with instruments in use.
the currently used multi-rules and a suggested minimum QC frequency.

*
Not available in USA
6
Interactive Levey-Jennings Charts

Identify trends, bias and precision problems at-a-glance

Levey-Jennings charts are easily generated by the software and can The test, date and SDI is easily displayed by hovering over any of the
be based on either SD or %DEV. Each chart provides an instant visual data points; further information can be accessed simply by clicking on
indication of whether or not a test is performing well. each individual data point.

Using the unique overview bar, users can scroll through past data to
look at previous trends or zoom in on a specific time period to provide
a more in-depth look at performance. The interactive nature of the
chart also allows users to add actions or comments for advanced data
review.

7
 Interactive Levey-Jennings Charts

Combine multiple levels of control, parameters and instruments on the same chart

With Acusera 24•7 Live Online, users have the ability to combine The navigation tree at the side of the chart allows users to select
multiple instruments, parameters and serum lots on a single, easy to multiple lots, instruments and parameters. Using the legend, users may
interpret chart. choose to show/hide data points to make charts more manageable.

The ability to customise charts in this way provides a means of assessing

QC performance from multiple instruments and enables users to
determine whether or not an issue is unique to a particular test or
instrument.

8
Interactive Histogram Charts

Displays your monthly Mean for each parameter, allowing identification of long term trends

Like the Levey-Jennings chart, the Histogram can be based on either The ability to display multiple data sets on a single chart enables
SD or %DEV and provides a visual representation of a laboratory’s laboratories to determine if the same shift in control values is seen
performance. between different levels of control or with more than one parameter.

Like all Acusera 24•7 charts, the interactive nature of the Histogram Similar to the Levey-Jennings chart, the SDI / %DEV from the Mean can
means users can zoom in on a specific month or time period for a be displayed by simply hovering over the bar relating to the month of
more in-depth look at performance. interest.

Users can choose to display data for multiple levels of control, multiple
parameters or multiple instruments on the same Histogram chart.

9
 Performance Summary Chart

Provides a visual assessment of both your accuracy and precision in relation to the peer group

The Performance Summary Chart highlights potential bias and precision Analytical performance can be quickly and easily interpreted by
issues, displaying your SDI on the y-axis and your CVI on the x-axis. identifying where your result falls in the shaded region.
Individual laboratory performance versus your chosen peer group are
plotted. A user’s cumulative or monthly results may be compared to
world or affiliate group statistics, enabling enhanced troubleshooting
capabilities.

10
Data Review

Evaluate and review any poor performing QC tests

The Data Review report displays data for all unreviewed QC tests As always, results are colour-coded for user convenience. Once results
which have fallen outside the laboratory’s user-defined performance have been evaluated, managers can record their actions by marking
limits. Data may be filtered by date, instrument, lot number or rule each result as ‘reviewed’. A ‘reviewed’ result will no longer appear on
violation. It may also be filtered to display only alerted/rejected results. the Dashboard.
The report can be exported or printed easily to document the review
process.

11
 Audit Trail Report

Provides a complete overview of historical actions that cannot be edited or deleted

The Audit Trail Report is a secure, computer generated, electronic The report can be filtered by any of the following criteria: date,
report displaying all events leading to the creation, modification and instrument ID, lot number, test or action. The report can be easily
deletion of an electronic record. converted to PDF and printed for reference.

Regulatory bodies frequently require laboratories to document review

of their QC data. Actions, comments and audit trails, when used in
combination, provide an effective way of documenting the review
process whilst providing a secure method of storing data.

12
Peer Group Statistics

Users can select the peer group statistics to which their results are compared

Several options are available: Peer group data is generated from our extensive database of
• All methods laboratory participants and is uniquely updated every 24 hours,
• Method ensuring effective troubleshooting and access to the most up-to-date
• Method / Reagent information available.
• Method / Instrument Model
• Method / Instrument Model / Reagent Peer group data can be compared to worldwide peer group statistics or

• Method / Instrument Group affiliate group statistics. Group co-ordinators can view the performance

• Method / Instrument Group / Reagent of others in their group of affiliate laboratories.

13
 Statistical Analysis Report

Compare monthly and cumulative statistics to worldwide peer group data

The Statistical Analysis Report provides a complete overview of Peer group statistics are uniquely updated every 24 hours providing
laboratory performance for any given month. This report encompasses users with access to the most relevant data available.
many vital statistics including the , SD, CV, SDI and CVI. It can be used
to compare both monthly and cumulative data for each individual test The Statistical Analysis Report can be exported to PDF or .csv file

to worldwide peer group statistics. Participants may also choose to formats and printed for review purposes.

compare their results to other laboratories in their group or chain via

the Statistical Analysis (Group) Report.

14
Acusera 24•7 Connect

Acusera 24•7 Connect is a complementary hardware and software solution designed to provide
a fully automated method of securely importing QC data direct from your laboratory’s LIS or
middleware to Acusera 24•7 Live Online.

• Highly convenient, eliminating issues associated with manual • Imports QC data only, any patient test results are automatically
data entry. ignored.
• Increased productivity and efficiency. • Provides a secure real-time connection.

QC result capture options

The diagram below demonstrates the three different methods of transferring QC data to Acusera 24•7 Live Online.

1 Fully automated import via Acusera 24•7 Connect.

2 Manual data entry.
3 Semi-automated import using EDI Mapping.

1 2 Manual 3
entry

Analyser Analyser

File Import Acusera Acusera EDI File Import LIMs/LIS

24•7 Connect 24•7 Live Online Mapping

LIMs/Middleware Middleware

Your Laboratory Process Automated QC Data Management Semi-Automated Your Laboratory Process

15
 FAQs

What is the speed? Is there a limitation to the number of concurrent users?

The speed depends on your laboratory’s local network, internet There is no limit to the number of concurrent users.
connection and other activities utilising the bandwidth.
What if I forget my username or password?
How secure is Acusera 24•7 Live Online? If an individual with user level or manager level access forgets their
To authenticate useres, a number of security measures are username and password, they should contact the administrator.
used, including: participant number, username and a password If an administrator or group co-ordinator forgets their username
combination. Password complexity standards are enforced or password they should contact Randox who will verify the
on user account setup. CAPTCHA is enforced after several administrator and send a new link to the registered email
failed login attempts to prevent against automated attacks as account.
well as individual role based accounts, and X509 certificate
authentication when sending results via Acusera 24•7 Connect How many user levels are available?
to meet security industry standards. There are five user levels available: administrator, manager, user, co-
ordinator and technical support. Co-ordinators will have access to
Are there any additional software requirements? all group data but will not be able to edit, delete or add any details.
You must have access to a Java applet. This software is available
as standard on almost all modern computers, laptops and How is Acusera 24•7 Live Online upgraded?
notebooks. All new Acusera 24•7 releases will be available online
automatically. Additional installation of software is not necessary.
How much data can be stored?
There are currently no limitations to the amount of data storage. Is Acusera 24•7 Live Online available in any other languages?
Laboratories do not need to backup separately as Randox stores Yes, Acusera 24•7 Live Online is currently available in English,
all data securely. Spanish, Italian, French, Portuguese, Chinese, German and Swedish.
A unique software selection facility allows users to switch between
Is Acusera 24•7 Connect required to import QC data? languages if and when required.
Acusera 24•7 Connect is only required if you wish to import
QC data automatically. Data can also be entered manually using How do I register for Acusera 24•7 Live Online?
the data entry screen or in a semi-automated manner using the Register interest via www.acusera247.com. All participants
EDI function. will be registered on the host system; Live Online users will be
flagged and emailed a link to provide administrator access. The
What if the connection goes down? administrator will then set up all other users with their access
If connection is lost from the laboratory’s side, all data will be level, username and password.
transferred to the web and once reconnected, the previous
session will also be remembered. Emergency power generators Will the data be recorded with our local time?
and fall over servers are in place to ensure 99.8% uptime is Time zone is assigned initially at registration. All data is then
guaranteed. recorded against a universal co-ordinated time (UTC).

Ordering Details

Description Cat. No.

Acusera 24•7 Live Online Peer Group Activation and 12 Month License QC4218
Acusera 24•7 Live Online Peer Group 12 Month License Renewal QC4204
Acusera 24•7 Connect+ QC4205
Acusera 24•7 Advisor* QC4223
Acusera 24•7 Live Online Upgrade from Acusera 24•7 Live QC4220
Acusera 24•7 Live Online Training QC4221
+
Pending site survey completion
*
Not available in USA

16
Software & Connectivity Solutions

Randox offers two different solutions for participation in the while Acusera 24•7 Live is suited to laboratories requiring a
Acusera 24•7 interlaboratory data management program. more basic range of features.The table below is designed to help
Acusera 24•7 Live Online eliminates the need to install and you determine the best solution for your laboratory.
update software locally, making it ideal for group installations,

Features Acusera 24•7 Live Online Acusera 24•7 Live

Type of Solution
Web service (internet based)  §
Desktop software § 
Platform
Hosted by Randox  §
Installed on PC § 

Requirements
Internet Connection   (for peer group only)
QC Data Management
QC multi-rules  
Acusera Advisor*  §
Suitable for use with other manufacturers’ controls  
Dashboard Interface  §
Data Review  §
Charts
Summary of results  
Audit Trail Report  §
Levey-Jennings Chart  
Multi Levey-Jennings Chart  §
Histogram Chart  
Multi Histogram Chart  §
Performance Summary Chart  
Peer Group Statistics  
Reports
Audit Trail Report  §
Analytical Goals
Medical Relevance  
RIQAS Target Deviation  
Peer Group Data
Updated every 24 hours  
Connectivity
Automated upload of QC data  §
Semi-automated upload via EDI  
Manual data entry  

*
Not available in USA
17
 Related Products

True third party controls offering complete test menu consolidation

Randox is a world leading provider of multi-analyte, third party

controls designed to help streamline QC in even the most
demanding laboratories. Our unique combination of analytes
enables complete test menu consolidation and will ultimately
reduce costs and preparation time without compromising on
quality or performance.
Helping to facilitate ISO 15189 accreditation, our complete range
of true third party controls will enable unbiased performance
assessment with any instrument or method.

Why choose Randox as your third party QC provider?

• The most accurate controls available with target values
traceable to reference methods ensuring unrivalled accuracy Product Portfolio
and reliability
• Blood Gas • Immunology/Proteins
• Partner of choice to national EQA schemes worldwide,
• Cardiac Markers • Lipids
testament that our QC materials are of the highest quality and • Clinical Chemistry • Speciality/Research
reliability • Coagulation • Therapeutic Drugs
• The most commutable controls available ensuring performance • Diabetes • Toxicology
mimics that of the patient sample • Haematology • Urinalysis
• Availability of lyophilised, liquid frozen and liquid ready-to-use • Immunoassay • Urine Chemistry
controls

The largest global EQA scheme with over 31,000 laboratory participants

When it comes to EQA there is power in numbers. With over

31,000 laboratory participants in more than 115 countries
worldwide RIQAS truly is the largest EQA provider globally.
Our comprehensive product offering currently covers over
360 parameters and 24 flexible EQA programmes. Each
programme contains a unique combination of parameters
meaning laboratories can significantly reduce the number of
individual programmes required while increasing efficiency and
reducing costs. Further benefits include accreditation to ISO
17043:2010, frequent reporting and the ability to register up to
5 instruments for each programme at no extra cost.

Why choose RIQAS as your EQA provider?

Product Portfolio • Internationally accredited to ISO/IEC 17043:2010 ensuring
• Ammonia/Ethanol • Immunoassay Speciality II added confidence in all aspects of the scheme organisation
• Blood Gas • Lipids • Flexible reporting options available to suit laboratories of all
• BNP • Liquid Cardiac sizes and budgets
• Cardiac • Maternal Screening • User-friendly yet comprehensive reports allowing
• Clinical Chemistry • Serology Epstein Barr Virus performance assessment at a glance
• Coagulation • Serology HIV/Hepatitis
• Reports available within 72 hours of submission deadline
• ESR • Serology ToRCH
• Haematology • Serology Syphilis allowing any corrective actions to be taken immediately
• HbA1c • Specific Proteins • End-of-cycle reports provide a complete summary of
• Human Urine • Therapeutic Drugs statistics and allows comparison to the previous cycle
• Immunoassay • Urinalysis
• Immunoassay Speciality I • Urine Toxicology
18
 QUALITY CONTROL

INTERNATIONAL HEADQUARTERS
Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 [email protected] randoxqc.com

AUSTRALIA BRAZIL CHINA CZECH REPUBLIC

Randox (Australia) Pty Ltd. Randox Brasil Ltda. Randox Laboratories Ltd. Randox Laboratories S.R.O.
Tel: +61 (0) 2 9615 4640 Tel: +55 11 5181 2024 Tel: +86 021 6288 6240 Tel: +420 2 1115 1661

FRANCE GERMANY HONG KONG ITALY

Laboratoires Randox Randox Laboratories GmbH Randox Laboratories Hong Kong Limited Randox Laboratories Ltd.
Tel: +33 (0) 130 18 96 80 Tel: +49 (0) 2151/93 706 11 Tel: +852 3595 0515 Tel: +39 06 9896 8954

INDIA POLAND PORTUGAL PUERTO RICO

Randox Laboratories India Pvt Ltd. Randox Laboratories Polska Sp. z o.o. Randox Laboratorios Quimica Analitica Clinical Diagnostics of Puerto Rico, LLC
Tel: +91 80 2802 50 00 Tel: +48 22 862 1080 Tel: +351 22 589 8320 Tel: +1 787 701 7000

REPUBLIC OF IRELAND SLOVAKIA SOUTH AFRICA SOUTH KOREA

Randox Teoranta Randox S.R.O. Randox Laboratories SA (Pty) Ltd. Randox Korea
Tel: +353 7495 22600 Tel: +421 2 6381 3324 Tel: +27 (0) 11 312 3590 Tel: +82 (0) 31 478 3121

SPAIN SWITZERLAND USA VIETNAM

Laboratorios Randox S.L. Randox Laboratories Ltd. (Switzerland) Randox Laboratories-US, Ltd. Randox Laboratories Ltd. Vietnam
Tel: +34 93 475 09 64 Tel: +41 41 810 48 89 Tel: +1 304 728 2890 Tel: +84 8 39 11 09 04

find out more

LT244 SEP15

Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB
151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures
in the USA.