Interlaboratory Data Management – July 2019

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Interlaboratory Data Management – July 2019

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Acusera 24•7 Live Online is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities, Acusera 24•7 Live Online will help to meet regulatory requirements, improve error detection, reduce false rejections and ensure accurate patient results.

Delivering an online platform for effective QC data management, our software provides unique access to instantly updated real-time peer group data, automatically generated QC statistics, QC multi-rules, interactive charts and comprehensive reports.

‘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 significant errors the results shall be rejected… Quality Control data shall be reviewed at regular intervals to detect trends in examination performance’.

ISO 15189:2012

Why implement an interlaboratory program?

Acusera 24•7 Live Online is an essential QC tool for laboratories of all sizes. By participating and implementing our software your laboratory will be able to do the following;

  • Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
  • Automatically calculate Measurement Uncertainty, Total Error and Sigma Metrics
  • Bridge the gap between daily quality control and external quality assessment
  • Improve EQA performance by eliminating any undetected bias
  • Facilitate regulatory compliance
  • Minimise false rejections through the use of QC multi-rules
  • Increase confidence in assigned QC target values
  • Speed up troubleshooting processes, shortening delays in reporting

Acusera 24•7 key features and benefits

Peer group statistics are now uniquely updated live in real-time ensuring immediate access to the most up to date information available while ultimately reducing time and money spent troubleshooting, re-running samples and performing instrument maintenance. Peer groups may be based on worldwide statistics or an affiliate group of laboratories meaning you can instantly discover how you compare to other laboratories using the same lot of QC and identify if issues are unique to your laboratory or a widespread problem.

Available at no extra cost the unique dashboard allows instant identification of any QC failures and from the last seven days. Designed to significantly reduce the time spent analysing data, this highly convenient and user-friendly function means corrective action can be taken immediately with minimum disruption to the laboratory’s output. Alerts are also provided when a control lot is reaching expiry, reducing the risk of using expired material.

Levey-Jennings, Histogram and Performance Summary Charts are generated on demand, delivering quick and easy performance monitoring. With Acusera 24•7 Live Online, users have the ability to add multiple instruments, parameters and lots to a single chart allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.

The user-friendly interface and interactive nature of the chart allows you to view data for a specific date range, zoom in on a specific data point, comment on individual data points and record events including calibration and reagent lot changes for enhanced review of trends.

 

Our software now automatically calculates %Bias, Total Error and Sigma metrics, enabling enhanced performance assessment and improved QC strategy design for your laboratory. The added benefit of Uncertainty of Measurement (UM) helps to meet ISO 15189 requirements. In addition results may be rejected or alerted based on QC multi-rules or user defined performance limits including Rilibak, CLIA and biological variation.

The Acusera Advisor tool will conveniently recommend a set of QC multi-rules and a minimum QC frequency for each assay based on previous performance history. Tailoring QC multi-rules to each assay in this way will make QC processes more efficient whilst ensuring high error detection rates.

Designed to help speed up the review process a range of comprehensive reports are available including, Statistical Metrics Reports, Uncertainty of Measurement Report, Exception Report, and the Audit Trail Report which provides a secure, electronic record of the creation, modification and deletion of data. This effective method of documenting the review process can help laboratories meet regulatory requirements and gain accreditation.

 

Evaluate and review any poor performing QC tests

The Data Review report displays data for all QC tests which have fallen outside your laboratory’s user-defined performance limits. Data may be filtered by date, instrument, lot number or rule violation. It may also be filtered to display only alerted/rejected results. The report can be exported or printed easily, to document the review process.

As always, results are colour-coded for added convenience. 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.

Our fully automated connectivity solution is designed to meet the needs of all laboratory types and sizes. QC data can be quickly and efficiently imported from LIMS to Acusera 24•7 Live Online without the need to import files or manually enter data.

  • Reduce workload by eliminating issues associated with manual data entry
  • Increases productivity and efficiency
  • Captures and imports only QC data
  • Secure real-time connection without disruption to the laboratory
  • The software is also capable of bi-directional communication with LIMS

Packages For Customisation

There are several options available for participation in Acusera 24•7, ranging from basic to advanced user options. Click below to learn more.


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RX series (Concept 3)

clinical chemistry analyser

The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.

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Why Choose the RX series?

Consolidation of Routine & Specialised Testing on One Single Platform 

With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.

Low Reagents & Sample Volumes

Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering  accurate, reliable and precise results each time, every time.

Robust Hardware & Intuitive Software 

The RX series boasts many features including user-friendly Windows based software, an in-built inventory management system and multiple levels of password protection ensuring optimum performance, flexibility and excellent functionality.

Unrivalled Customer Support

Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.

View Our Test Menus

Fully Automated
Test Menu

Semi-Automated
Test Menu

Niche
Test Menu


QCMD – Molecular External Quality Control

QCMD - Molecular EQA for Infectious Disease Testing
QCMD Coronavirus

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Features & Benefits

Frequency

A variety of programme options are available.  Choose the number of challenges that best suit your laboratory’s  requirements.

Online EQA Management System

ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

High level of participation

Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

Comprehensive reports

Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

International accreditation

Programmes are accredited to ISO 17043.

EQA Programmes
  • Blood Borne Viruses
  • Central Nervous System Diseases
  • Drug Resistance
  • Exotic / Emerging Diseases
  • Gastrointestinal Diseases
  • Immunocompromised Associated Diseases
  • Multiple Pathogen / Syndromic Infections
  • Respiratory Diseases
  • Serology
  • Sexually Transmitted Infections
  • Transplant Associated diseases
  • Typing
  • New Pilot Studies
Reports & Feedback

After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

Explore Further

Contact Us

QCMD Website

RIQAS EQA

*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.

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Meeting ISO 15189:2012 Requirements for Multiple Instruments

Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.

About ISO 15189:2012

ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.

Gaining Accreditation

ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.

A particular requirement of ISO 15189:2012 is:

“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”

How Randox can help labs with multiple instruments?

Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.

RIQAS

Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.

Multi-Instrument Reports

All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.

The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.

Acusera 24.7 Live Online

Our stress free QC analysis software is designed to assist in the management of daily QC activities.

Support for multiple instruments

Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.

Helping you get accredited

Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.

To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.

Meet ISO 15189 Requirements for Multiple Instruments

Acusera 24.7 Packages Explained

Acusera 24.7 Packages Explained

Packages for Customisation

Acusera 24.7 now boasts even more customisation with the introduction of three distinct packages; Platinum, Gold & Silver.

The Acusera 24.7 software is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities by providing access to an impressive range of features, including interactive charts and real-time peer group data, Acusera 24.7 Live Online will improve error detection, reduce false rejections, ensure accurate patient results, and help you meet regulatory requirements, such as ISO 15189

The introduction of the new Acusera 24.7 packages ensures a solution to suit laboratories of all sizes and budgets.  All three membership packages give our users access to the world-renowned Acusera 24.7 global peer group, but users now have the flexibility to choose whether they require access to additional features to help revolutionise their QC strategy.

Package Benefits

FEATUREPLATINUMGOLDSILVER
Access to real-time peer group data
FEATUREPLATINUMGOLDSILVER
Multiple levels of user access
Unlimited number of registered users
FEATUREPLATINUMGOLDSILVER
Custom Multi-Rules
Ability to use other manufacturer controls or custom controls
FEATUREPLATINUMGOLDSILVER
Data import via Acusera 24•7 Connect
Manual data entry by panel
Semi automated data entry via EDI
Recording of instrument events
FEATUREPLATINUMGOLDSIGNIFICANCE
Automatic calculation of Mean, SD and %CV
Result History
Automatic calculation of %Bias and Total Error
Automatic calculation of Inter-Precision, Sigma Scores, Uncertainty of Measurement and Expanded Uncertainty
FEATUREPLATINUMGOLDSILVER
Statistical Analysis Report
Peer Group Statistics Report
Exception Report
Statistical Metrics Report
Uncertainty of Measurement Report
FEATUREPLATINUMGOLDSILVER
Levey-Jennings Chart
Histogram Chart
Performance Summary Chart
Multi-Levey Jennings/Histogram Charts
FEATUREPLATINUMGOLDSILVER
Dashboard
Audit Trail
Advisor Tool
Data Review

Learn More About Acusera 24.7 Packages

To learn more about Acusera 24.7 you can visit the webpage, download the brochure or contact us using the form below.


Complete QC solutions for results you can trust

Randox Quality Control aim to deliver the complete QC package and with our portfolio we believe we have something to offer every laboratory regardless of their size or budget.

The Randox Quality Control portfolio includes;

Designed to streamline QC in even the most demanding laboratories our complete QC solutions will save precious time and money through consolidation, ease-of-use and high quality products.

With accurate and reliable testing at the top of a laboratory’s priority list, we at Randox Quality Control strive to put you at the top of ours.

Request your FREE QC consultation

Randox Quality Control’s specialist QC consultants can provide your laboratory with a FREE consultation to demonstrate how we can help you streamline your laboratory, meet regulatory requirements and save time and money.

Simply fill out the form below to request your consultation today.

  • Signing up to our mailing list is quick and easy. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Read more in our Privacy Policy.

A week dedicated to unsung heroes! – Medical Laboratory Professionals Week 2017

From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.

Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care.  They perform and interpret billions of laboratory tests every year.

Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory QC for the in vitro diagnostics market, we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.

Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.


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