Acusera 24.7

Acusera 24.7
QUALITY CONTROL
Q
Q
24•7
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 world
wide peer group statistics, enabling rapid and effective troubleshooting.
Identify any trends, system errors or reagent issues
Acusera 24•7 will allow users to immediately detect and identify
errors in their laboratory test system.
Access to comprehensive charts and peer group data allows
users to identify problems that may otherwise have gone
unnoticed and assess if shifts in QC recovery are unique to their
laboratory. Access to peer group data may even alert lab staff
to future issues before they are encountered in their laboratory.
Minimise false rejections using QC multi-rules
The ability to apply user-defined QC multi-rules will help to
reduce false rejections and the number of repeat tests whilst
maintaining a high level of error detection. The new Acusera
Advisor tool will recommend QC multi-rules and a minimum
QC frequency based on method performance.
Bridge the gap between IQC and EQA
Acusera 24•7 is designed to complement your current EQA
scheme, providing users with added confidence in-between
samples.
EQA is performed retrospectively therefore, acceptable EQA
performance at the time of analysis does not guarantee the
accuracy and reliability of laboratory testing.
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
Have confidence in assigned target values
Together with data from RIQAS, the worlds largest international
EQA scheme, Acusera 24•7 provides immediate confidence in
assigned target values.
Facilitate regulatory requirements
Participation in an interlaboratory or peer group reporting
program is becoming compulsory in countries worldwide.
IS015189:2012 states that:
“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 clinically significant errors, the
results shall be rejected.... Quality Control data shall
be reviewed at regular intervals to detect trends in
examination performance.”
Get an independent perspective
Dedicated controls supplied by the instrument manufacturer
can mask weaknesses within a test system, increasing the risk
that a shift in patient results will go unnoticed.
The combination of Randox third party quality controls and
Acusera 24•7 can reduce the potential for bias and provide a
true assessment of analytical performance.
Acusera 24•7 Live Online Summary
Online access anytime, anywhere
• Eliminates the need for local installation and frequent back ups,
making it suitable for laboratory groups and chains.
• Convenient and easy to use.
Optional automated QC data import via Acusera 24•7
Connect
• Capable of connecting directly to your laboratory’s LIS or
Middleware.
• Increases productivity and eliminates the problems associated
with manual data entry.
Simple and intuitive user interface
• The software is colour coded throughout, enabling an instant
visual indication of poor performance.
• The built in help file is divided into user-friendly sections that help
to guide the user through the software.
Fully interactive charts
• Levey-Jennings, Histogram and Performance Summary Charts
are automatically generated, enabling identification of trends
or bias.
Real time peer group data
• Peer group statistics uniquely generated every 24 hours from
our extensive database of laboratory participants.
Comprehensive reports
•
A range of comprehensive reports are available, helping
laboratories to monitor performance and meet regulatory
requirements.
Highly flexible to meet individual laboratory needs
• Multi-lingual software.
• Although intended for use with the Acusera control range,
the software’s internal functions may be used with any QC
material.
Dashboard
• The unique Dashboard instantly flags any rejected or
alerted results and warns users when QC lots are approaching
expiry.
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
Mean and SD. Data is presented in a user-friendly format, allowing any
also indicates which rule has been violated. Users may add comments
sudden 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.
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.
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
• Method / Instrument Group
• Method / Instrument Group / Reagent
13
Peer group data can be compared to worldwide peer group statistics or
affiliate group statistics. Group co-ordinators can view the performance
of others in their group of affiliate laboratories.
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,
as well as control lots to worldwide peer group statistics. Participants
The Statistical Analysis Report can be exported to PDF or .csv file
formats and printed for review purposes.
may also choose to 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
data entry.
• Increased productivity and efficiency.
• Imports QC data only, any patient test results are automatically
ignored.
• 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
3
Manual
entry
Analyser
Analyser
File Import
Acusera
24•7 Connect
Acusera
24•7 Live Online
EDI
Mapping
LIMs/Middleware
Your Laboratory Process
15
File Import
LIMs/LIS
Middleware
Automated
QC Data Management
Semi-Automated
Your Laboratory Process
FAQs
What is the speed?
The speed depends on your laboratory’s local network, internet
connection and other activities utilising the bandwidth.
How secure is Acusera 24•7?
A number of security measures have been introduced including
participant number, username and password combination used
to authenticate users, password complexity standards enforced
on user account setup, CAPTCHA after several failed login
attempts to prevent against automated attacks, individual role
based accounts to ensure a principle of least privilege and X509
certificate authentication when sending results via the Connect
software to meet security industry standards.
Are there any additional software requirements?
You must have access to a Java applet. This software is available
as standard on almost all modern computers, laptops and
notebooks.
How much data can be stored?
There are currently no limitations to the amount of data storage.
Laboratories do not need to backup separately as Randox stores
all data securely.
Is Acusera 24•7 Connect required to import QC data?
Acusera 24•7 Connect is only required if you wish to import
QC data automatically. Data can also be entered manually using
the data entry screen or in a semi-automated manner using the
EDI function.
What if the connection goes down?
If connection is lost from the laboratory’s side, all data will be
transferred to the web and once reconnected, the previous
session will also be remembered. Emergency power generators
and fall over servers are in place to ensure 99.8% uptime is
guaranteed.
Is there a limitation to the number of concurrent users?
There is no limit to the number of concurrent users.
What if I forget my username or password?
If an individual with user level or manager level access forgets their
username and password, they should contact the administrator.
If an administrator or group co-ordinator forgets their username
or password they should contact Randox who will verify the
administrator and send a new link to the registered email
account.
How many user levels are available?
There are four user levels available: administrator, manager, user
and co-ordinator. Co-ordinators will have access to all group
data but will not be able to edit, delete or add any details.
How is Acusera 24•7 Live Online upgraded?
All new Acusera 24•7 releases will be available online
automatically. Additional installation of software is not necessary.
Is Acusera 24•7 available in any other languages?
Yes, Acusera 24•7 is currently available in English, Spanish, Italian,
French, Portuguese, Chinese, German and Swedish. A unique
software selection facility allows users to switch between languages
if and when required.
How do I register for Acusera 24•7 Live Online?
Register interest via www.acusera247.com. All participants
will be registered on the host system; Live Online users will be
flagged and emailed a link to provide administrator access. The
administrator will then set up all other users with their access
level, username and password.
Will the data be recorded with our local time?
Time zone is assigned initially at registration. All data is then
recorded against a universal co-ordinated time (UTC).
Ordering Details
Description
Cat. Number
Acusera 24•7 Live Online Peer Group Activation and 12 Month License
Acusera 24•7 Live Online Peer Group 12 Month License Renewal
Acusera 24•7 Connect*
Acusera 24•7 Advisor
Acusera 24•7 Live Online Upgrade from Acusera 24•7 Live
Acusera 24•7 Live Online Training
QC4218
QC4204
QC4205
QC4223
QC4220
QC4221
*pending site survey completion
16
Software & Connectivity Solutions
Randox offers two different solutions for participation in the
Acusera 24•7 interlaboratory data management program.
Acusera 24•7 Live Online eliminates the need to install and
update software locally, making it ideal for group installations,
Features
while Acusera 24•7 Live is suited to laboratories requiring a
more basic range of features.The table below is designed to help
you determine the best solution for your laboratory.
Acusera 24•7 Live Online
Acusera 24•7 Live
Type of Solution
Web service (internet based)

§
Desktop software
§

Hosted by Randox

§
Installed on PC
§


 (for peer group only)
QC multi-rules


Acusera Advisor

§
Platform
Requirements
Internet Connection
QC Data Management
Suitable for use with other manufacturers’ controls


Dashboard Interface

§
Data Review

§
Summary of results


Audit Trail Report

§
Levey-Jennings Chart


Multi Levey-Jennings Chart

§
Histogram Chart


Multi Histogram Chart

§
Performance Summary Chart


Peer Group Statistics



§
Medical Relevance


RIQAS Target Deviation




Automated upload of QC data

§
Semi-automated upload via EDI


Manual data entry


Charts
Reports
Audit Trail Report
Analytical Goals
Peer group Data
Updated every 24 hours
Connectivity
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 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
and reliability
• Partner of choice to national EQA schemes worldwide,
testament that our QC materials are of the highest quality and
reliability
• The most commutable controls available ensuring performance
mimics that of the patient sample
• Availability of liquid frozen and liquid ready-to-use controls
Product Portfolio
• Blood Gas
• Cardiac Markers
• Clinical Chemistry
• Coagulation
• Diabetes
• Haematology
• Immunoassay
• Immunology/Proteins
• Lipids
• Speciality/Research
• Therapeutic Drugs
• Toxicology
• Urinalysis
• Urine Chemistry
The largest global EQA scheme with over 31,000 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 in the
world.
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.
Product Portfolio
• Ammonia/Ethanol
• Blood Gas
• BNP
• Cardiac
• Clinical Chemistry
• Coagulation
• ESR
• Haematology
• HbA1c
• Human Urine
• Immunoassay
• Immunoassay Speciality I
Why choose RIQAS as your EQA provider?
• Immunoassay Speciality II
• Lipids
• Liquid Cardiac
• Maternal Screening
• Serology Epstein Barr Virus
• Serology HIV/Hepatitis
• Serology ToRCH
• Serology Syphilis
• Specific Proteins
• Therapeutic Drugs
• Urinalysis
• Urine Toxicology
• Internationally accredited to ISO/IEC 17043:2010 ensuring
added confidence in all aspects of the scheme organisation
• Flexible reporting options available to suit laboratories of all
sizes and budgets
• User friendly yet comprehensive reports allowing
performance assessment at a glance
• Reports available within 72 hours of submission deadline
allowing any corrective actions to be taken immediately
• End of cycle reports provide a complete summary of
statistics and allows comparison to the previous cycle
18
QUALITY CONTROL
INTERNATIONAL HEADQUARTERS
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413
AUSTRALIA
Randox (Australia) Pty Ltd.
Tel: +61 (0) 2 9615 4640
FRANCE
Laboratoires Randox
Tel: +33 (0) 130 18 96 80
INDIA
Randox Laboratories India Pvt Ltd.
Tel: +91 80 2802 50 00
REPUBLIC OF IRELAND
Randox Teoranta
Tel: +353 7495 22600
SPAIN
Laboratorios Randox S.L.
Tel: +34 93 475 09 64
+44 (0) 28 9445 2912
BRAZIL
Randox Brasil Ltda.
Tel: +55 11 5181 2024
GERMANY
Randox Laboratories GmbH
Tel: +49 (0) 2151/93 706 11
POLAND
Randox Laboratories Polska Sp. z o.o.
Tel: +48 22 862 1080
SLOVAKIA
Randox S.R.O.
Tel: +421 2 6381 3324
SWITZERLAND
Randox Laboratories Ltd. (Switzerland)
Tel: +41 41 810 48 89
[email protected]
CHINA
Randox Laboratories Ltd.
Tel: +86 021 6288 6240
HONG KONG
Randox Laboratories Hong Kong Limited
Tel: +852 3595 0515
PORTUGAL
randoxqc.com
CZECH REPUBLIC
Randox Laboratories S.R.O.
Tel: +420 2 1115 1661
ITALY
Randox Laboratories Ltd.
Tel: +39 06 9896 8954
PUERTO RICO
Randox Laboratorios Quimica Analitica
Tel: +351 22 589 8320
Clinical Diagnostics of Puerto Rico, LLC
Tel: +1 787 701 7000
SOUTH AFRICA
SOUTH KOREA
Randox Laboratories SA (Pty) Ltd.
Tel: +27 (0) 11 312 3590
USA
Randox Laboratories-US, Ltd.
Tel: +1 304 728 2890
Randox Korea
Tel: +82 (0) 31 478 3121
VIETNAM
Randox Laboratories Ltd. Vietnam
Tel: +84 8 39 11 09 04
LT244 MAR15
find out more
Information correct at time of print. Randox Laboratories Limited 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.
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