Acusera 24.7 - Randox Laboratories

QUALITY CONTROL
Acusera 24•7 Live Online
The future of interlaboratory data management
live online
AN EFFECTIVE TOOL FOR EVALUATING LABORATORY PERFORMANCE
The Randox Acusera range of internal quality controls is the
most accurate, stable and consistent on the market. As true
third party controls, they are not designed or optimised for use
with a specific reagent or instrument manufacturer, providing a
true, unbiased assessment of laboratory performance.
An effective IQC and peer group reporting scheme like
Acusera 24•7 will help to improve your laboratory’s analytical
performance, meet regulatory requirements and most
importantly ensure the accuracy and reliability of patient test
results.
The use of internal quality controls however is only the first step
in improving analytical performance. The ability to interpret data
and effectively monitor performance is essential in establishing
and maintaining reliability, accuracy and precision.
Acusera 24•7 enables laboratories to extensively monitor
analytical performance, access peer group reports and compare
results with other laboratories using the same quality controls,
method and instrument.
Randox Acusera 24•7 is an Interlaboratory Data Management
package, designed specifically to complement the Acusera range
of third party controls and aims to improve the effectiveness
of quality control processes within the clinical laboratory, whilst
also helping to interpret QC results.
2
live online
WHY PARTICIPATE IN ACUSERA 24•7?
Receive reliable information from a trustworthy
source
Acusera 24•7 peer group statistics are generated every 24
hours from up to 20,000 laboratory participants worldwide.
This large number of participants ensures an extensive database
of results for many analytical methods, assures validity and
therefore increases confidence in your results.
Identify any trends, system errors or reagent issues
as soon as they arise
Acusera 24•7 will allow you to detect and identify errors
in your laboratory test system, thus minimising expensive repeat
tests and unnecessary troubleshooting.
By comparing your IQC results with peer group data you can
identify problems that otherwise may have gone unnoticed and
assess if shifts in QC recovery are unique to your laboratory.
Access to peer group data may even alert you to future issues
before they are encountered in your laboratory.
Minimise false rejections using QC multi-rules
The ability to apply user-defined QC multi-rules will help to
minimise false rejections and reduce the number of repeat tests
whilst maintaining a high level of error detection.
Improve EQA/PT performance
Acusera 24•7 is designed to complement your current EQA/
PT scheme providing you with added confidence in-between
samples.
EQA is performed periodically providing a retrospective
assessment of performance. Acceptable EQA performance
at the time of analysis does not guarantee the accuracy and
reliability of laboratory testing raising the question, how is
performance monitored between EQA samples?
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 and meet ISO 15189
accreditation
Laboratory managers are under increasing pressure to closely
monitor laboratory test results and assure their quality due
to growing demands from higher authorities for national and
international accreditation.
ISO 15189 states that laboratory management should monitor
EQA results and implement corrective actions in situations
where quality control criteria is not fulfilled. Good internal
quality control procedures including peer group reporting and
interlaboratory participation can help meet such requirements.
Get an independent perspective
Dedicated controls supplied by the instrument manufacturer
often contain the same raw materials as the calibrator making
them less sensitive to changes in performance. As such there
is increased 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.
Access peer group data 24 hours a day, seven days
a week
With Randox Acusera 24•7 peer group data is uniquely
updated every 24 hours giving you access to the most upto-date information available. This is extremely useful when
troubleshooting performance issues and resolving them as soon
as they occur.
Participation in an effective interlaboratory programme 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 and provide comparison data for parameters
unavailable in your current EQA programme.
3
live online
HELP MEET REGULATORY REQUIRMENTS
The Acusera 24•7 software is designed to be used as
an extension to your laboratory’s internal quality control
procedures. Participation in an interlaboratory or peer group
reporting programme is becoming increasingly compulsory in
countries worldwide.
In other countries where participation is not yet compulsory,
there is a general drive towards it, as it is considered to be highly
beneficial and cost effective.
Good quality assurance is vital in reducing errors and ensuring
confidence in patient test results. A quality assurance package
should incorporate all aspects of quality.
4
Randox offers quality management solutions for:
• Internal Quality Control - Acusera QC
• Peer Group Reporting - Acusera 24•7
• External Quality Assessment - RIQAS
ISO 15189 outlines the requirements for quality and
competence in medical laboratories; it concludes that clinical
laboratories should participate in interlaboratory comparisons
such as those organised by external quality assessment
schemes, monitor results closely and implement corrective
actions in situations where quality control criteria is not
fulfilled. Good internal quality control procedures including
peer group reporting and interlaboratory participation can
help meet such requirements.
live online
ACUSERA 24•7 LIVE ONLINE SUMMARY
Web based for added convenience and ease of use
• No need for local installation, eliminates frequent need to
update or backup software and reduces the support necessary
from on-site IT staff.
• Online access anytime, anywhere.
Connectivity solutions via Acusera 24•7 Connect
• Connects direct to your laboratory’s LIS or middleware
facilitating automated data import.
• Increases productivity and reduces the problems associated
with manual data entry.
Unrivalled peer review
• Peer group data is uniquely updated every 24 hours.
• Peer group data generated from up to 20,000 independant
laboratory participants.
• Rapid access to current peer group data, aids the troubleshooting
process and may even help to identify issues before they arise.
Simple and intuitive user interface
• A unique dashboard is automatically displayed upon logging
into the software, highlighting any unreviewed QC tests that
have fallen outside user defined performance limits in the last
seven days.
• The data entry screen can be used to manually enter QC data
but also displays monthly and cumulative stats for each lot of
control. Results are colour coded ‘orange’ for alert and ‘red’
when rejected allowing quick and easy identification.
• Multi-level access and encrypted passwords ensure security and
confidentiality whilst providing access for all laboratory personnel.
Fully interactive charts
• Combine data for multiple QC lots, parameters and
instruments on a single Levey-Jennings or Histogram chart for
enhanced review of trends and shifts.
• Performance summary charts provide a visual indication of any
bias or imprecision issues.
Comprehensive reports
• Detailed reports are available to help monitor and review
laboratory performance.
• The secure audit trail report records all actions relating to
the creation, modification and deletion of data providing a
useful tool for documenting the review process and meeting
regulatory requirements.
Highly flexible to meet individual laboratory needs
• The software is available in multiple languages including English,
Spanish, Italian, French, Portuguese and Chinese.
• Although designed primarily for use with the Acusera range
of IQC, Acusera 24•7 may be used with any control material,
however in such instances peer group data will not be available.
• Laboratories can choose to manually set stricter performance
limits around controls’ levels of significance (medical relevance)
or set peer group statistics as acceptable performance limits
(State of the Art).
5
live online
DASHBOARD INTERFACE
The unique dashboard interface provides a rapid indication of poor performance
The dashboard interface is a pre-defined homepage that is
automatically displayed and updated each time a user logs onto
the software.
The dashboard instantly brings any unreviewed QC tests which
have fallen outside the user-defined performance limits in the
last seven days to the user’s attention. This highly convenient
and user friendly function of the software allows quick and easy
identification of any poor performing tests that require further
investigation.
6
The date, instrument, analyte, lot number, result, mean, SD, SDI
and rule violation are displayed. Results are colour coded red for
reject and orange for alert.
live online
DATA ENTRY
The data entry function provides users with a visual overview of current analytical performance
The data entry function is used to manually enter QC data, but
also provides an on-screen summary of all QC data entered to
date. Acusera 24•7 will automatically calculate statistical data,
including the mean and standard deviation. Data is presented in
a user-friendly format allowing any sudden or gradual changes in
performance to be identified immediately.
Results are colour coded so that those outside acceptable limits
of performance are highlighted in orange for ‘alert’ and red when
‘rejected’ allowing for quick and easy identification. The system
also provides a reason for the poor performance and indicates
which rule has been violated. Users may add comments or
actions enabling advanced data review.
The summary provides both monthly and cumulative data and
enables comparison to a user defined fixed mean and standard
deviation. Each laboratory can set fixed values based on peer
group statistics or other values such as the target and range
quoted for the particular lot of control material in use.
7
live online
DATA REVIEW
Evaluate and review any poor performing QC tests
The data review screen displays data for all unreviewed QC
tests which have fallen outside the laboratory’s user defined
performance limits. The data can be filtered by date, instrument,
lot number, rule violation, rejected results only or alerted results
only. The report can be exported or printed easily to document
the review process.
8
As always, results are colour coded for quick and easy
identification. 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 as out
of range.
live online
INTERACTIVE LEVEY-JENNINGS CHARTS
Identify trends, bias and precision problems at a glance using fully interactive Levey-Jennings charts
Levey-Jennings charts are easily generated by the software and can
be based on either standard deviation or percentage deviation.
Each chart provides an instant visual indication of whether or not
a test is performing well.
Using the unique overview bar, you 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 you to add actions
or comments, for advanced data review.
The date and deviation from the mean is easily displayed by
hovering over any of the data points, further information including
the actual result obtained can be accessed simply by clicking on
each individual data point. Depending on their preference, users
may choose to hide either the data points or the daily mean line.
9
live online
INTERACTIVE LEVEY-JENNINGS CHARTS
Combine multiple levels of control, parameters and instruments on the same chart
Multiple data sets can be generated by simply combining results
for multiple parameters, instruments or lot numbers on one
easy to interpret chart.
10
The ability to combine data for multiple levels of quality control
on a single Levey-Jennings chart allows you to see if the same bias
or the same trends are seen with more than one level of control.
The ability to combine multiple parameters and instruments on
the same chart enables you to check if the same level of bias
or the same trends are seen across different parameters or
instruments.
live online
INTERACTIVE HISTOGRAM CHARTS
The histogram displays your monthly mean for each parameter allowing any long term trends to be
identified and corrected as soon as possible
Like the Levey-Jennings chart, the histogram can be based
on either standard deviation or percentage deviation and
provides a visual representation of a laboratory’s performance.
The histogram chart is extremely useful in identifying both shifts
(abrupt changes) and trends (gradual changes over time) in
your monthly results. Each bar on the chart represents a single
calendar month.
Like all charts the interactive nature of the histogram means
users can zoom in on a specific month or time period for a
more in-depth look at performance.
You can choose to display data for multiple levels of control,
multiple parameters or multiple instruments on the same
histogram chart. The ability to display multiple data sets on a
single chart enables laboratories to determine if the same shift
in control values is seen between different levels of control or
with more than one parameter.
Like the Levey-Jennings charts the SDI and % Deviation from the
mean can be displayed by simply hovering over the bar relating
to the month of interest.
11
live online
LABORATORY PERFORMANCE OVERVIEW REPORT
Performance summary charts allow cumulative and monthly data to be compared to peer group data
based on world or affiliate group results
The performance summary report highlights potential bias and
imprecision issues, displaying your SDI on the y-axis and your CVI
on the x-axis.Your laboratory’s performance versus your chosen
peer group and method peer group are plotted.Your cumulative
or monthly results can be compared to world or affiliate group
statistics enabling enhanced trouble shooting capabilities.
12
Analytical performance can be quickly and easily interpreted by
identifying where your result falls in the shaded region.
The interactive nature of the chart allows you to add multiple
parameters to the same chart.
live online
PEER GROUP STATISTICS
Using Acusera 24•7 you can select the peer group statistics to which your results are compared
Acusera 24•7 allows you to select the peer group statistics to
which your results are compared.
Several options are available:
• All methods
• Method
• Method / Reagent
• Method / Instrument Model
• Methods / Instrument Model / Reagent
• Method / Instrument Group
• Method / Instrument Group / Reagent
Peer group data is uniquely updated every 24 hours giving you
access to the most up to date information available. This aids
troubleshooting and may even help you to identify issues before
they arise in your lab.
Peer group data can be customised to compare either to your
peers worldwide (world statistics) or to your peers in a selected
affiliate group (group statistics). Group co-ordinators can view
the performance of others in their group of affiliate laboratories.
13
live online
AUDIT TRAIL REPORT
Providing a complete overview of historical actions that cannot be edited or deleted
The audit trail report is a secure, computer generated electronic
report displaying all events leading to the creation, modification
and deletion of an electronic record.
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.
14
The report can be filtered by any of the following criteria: date,
instrument ID, lot number, test or action. For each event the
date, instrument, lot number, assay, event, operator, action and
audit type are displayed. The report can be easily converted to
pdf and printed for reference.
live online
LABORATORY COMPARISON REPORT
The laboratory comparison report is available to laboratory groups or chains and displays both monthly
and cumulative instrument statistics of each laboratory compared to their group
The laboratory comparison report is ideal for QC co-ordinators
or laboratory managers who are responsible for multiple
laboratory sites. The report is available on request at the
laboratory’s desired frequency and allows any poor performing
laboratories to be identified easily.
Method, instrument and group statistics are provided for each lot
of control in use and each parameter tested.The report includes
many vital statistics including the mean, Standard Deviation (SD),
Percentage Coefficient of Variation (%CV), Standard Deviation
Index (SDI) and Coefficient of Variation Index (CVI).
15
live online
EXCEPTION REPORT
Allows large laboratory chains or groups to view all analytes that exceed the pre defined SDI/CVR
The exception report is ideal for quality control coordinators or
laboratory managers who manage multiple laboratory sites or
multiple instruments.
16
The report is available on request at the laboratory’s desired
frequency and lists any analytes that exceed the pre-defined
performance limits set by the laboratory group co-ordinator.
live online
ACUSERA 24•7 CONNECT
Acusera 24•7 Connect is a supplementary software solution designed to provide a fully automated
method of securely importing QC data direct from your laboratory’s instrument, LIS or middleware
to Acusera 24•7 Live Online.
• Highly convenient, eliminating issues associated with manual
data entry.
• Increased productivity and efficiency.
• Provides a secure real time connection.
• Imports QC data only, will not interfere with patient test
results.
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
LIMs/LIS
Analyser
File Import
Acusera
24•7 Connect
Acusera
24•7 Live Online
EDI
Mapping
Middleware
Your Laboratory Process
File Import
LIMs/LIS
Middleware
Automated
QC Data Management
Semi-Automated
Your Laboratory Process
17
live online
FAQs
What is the speed?
The speed depends on your laboratory’s local network, internet
connection and other activities utilising the band width.
How secure is Acusera 24•7?
A number of security measures have been introduced including
automatic lock out after several failed login attempts, password
reset based on a security question; individual role based accounts
and recorded IP addresses.
Is any additional software required?
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 semi-automated 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.
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 technical support at Acusera
24•7 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 and Chinese. 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.
Is data recorded with my local time?
Time zone is assigned initially at registration. All data is then
recorded against a universal co-ordinated time (UTC).
Is there a limitation to the number of concurrent users?
There is no limit to the number of concurrent users.
Ordering details
DescriptionCat. Number
24•7 Live - (non peer group, 12 month licence)
24•7 Live - (peer group activation, 12 month licence)
24•7 Live - (peer group, 12 month licence renewal)
QC4200
QC4201
QC4201/U
24•7 Live Online - (peer group activation,12 month licence)
24•7 Live Online - (peer group, 12 month licence renewal)
QC4218
QC4204
18
Please note:
The Acusera 24•7 Live software
(QC4200) can be purchased with
or without the peer group reporting
license (QC4201). This option is
ideal for laboratories that want to
use only the internal QC functions
of the software e.g. QC multi-rules,
statistics and charts. There will be a
separate charge for the software,
peer group license and Acusera
24•7 Connect.
live online
ACUSERA 24•7 SOFTWARE AND CONNECTIVITY SOLUTIONS
Randox offers two different solutions for participation in the
Acusera 24•7 interlaboratory data management programme.
Acusera 24•7 Live Online eliminates the need to install and
update software locally in your laboratory, making it ideal
Features
for group installations while Acusera 24•7 Live is suited to
laboratories looking for 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

Platform
Hosted by Randox

Installed on PC

Requirements
Internet Connection

 (for peer group only)
QC multi-rules (Westgard rules)


Suitable for use with other manufacturers controls


Dashboard Interface

Data Review

QC Data Management
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


Laboratory Comparison Report*


Exception Report*


Audit Trail Report




Reports
* Reports will have an extra charge associated.
Analytical Goals
Medical Relevance


RIQAS Target Deviation (State of the Art)









Peer group Data
Updated every 24 hours
Connectivity
Automated upload of QC data
Semi-automated upload via EDI
Manual data entry
19
QUALITY CONTROL SERUM
The Acusera range of third party controls covers over 350 routine and specialised parameters.
Accurate target values
Randox controls have the most accurately assigned target
values and ranges available. This is made possible through
access to a unique database of over 20, 000 laboratory
participants.
Consolidation
With the Acusera range of multi-analyte controls you can
dramatically reduce costs and the number of controls used
in your laboratory by replacing multiple instrument specific
controls with a single multi-analyser product.
Unrivalled stability
Randox lyophilised controls have a shelf life of up to four years
eliminating the problems associated with changing lot number
and enabling long term QC monitoring. The extended working
stability of many controls means they will meet and often
exceed stability expectations.
Most consistent material
Adherence to strict manufacturing processes keeps variation
between lots to a minimum.
Convenient and easy to use
Many controls are available in liquid and liquid ready-to-use
formats eliminating variability due to reconstitution errors.
Highest quality material
The Acusera range of lyophilised controls contain no added
preservatives or stabilisers which can cause interference.
Furthermore all controls for use with antibody based methods
are made from 100% human serum providing a matrix similar
to the patient sample.
True third party controls
Randox controls are not designed or optimised for use with
a specific test/system providing an independent, unbiased
assessment of performance.
Quality Control offering
Clinical Chemistry
Immunoassay
Urine Chemistry
Urinalysis
Lipids
Cardiac markers
Immunology/Proteins
Coagulation
Blood Gas
Diabetes
Therapeutic Drugs
Toxicology
Speciality/Research
RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME
RIQAS is the largest global EQA scheme with over 23, 000 laboratory participants in more than 105
countries worldwide.
Global accreditation to ISO/IEC 17043:2010.
Reduced parameter and reporting options available.
Comprehensive yet user friendly reports.
Reports available within 24 - 72 hours of final submission
date.
• Blind samples covering clinically relevant concentrations.
• Extensive analyte menu enabling significant programme.
RIQAS Programme offering
Blood Gas
Cardiac
Clinical Chemistry
Coagulation
Glycated Haemoglobin
Haemataology
Human Urine
Immunoassay
Immunoassay Speciality I
Immunoassay Speciality II
Lipids
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com
Liquid Cardiac
Maternal Screening
Serology (EBV)
Serology (HIV-Hepatitis)
Serology (Syphilis)
Serology (ToRCH)
Specific Proteins
Therapeutic Drugs
Urinalysis
Urine Toxicology
LT244 SEP13
•
•
•
•
Information correct at time of print.
Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information.

Download Report