CLIN LAB 2017
Randox Laboratories will be attending Clin Lab from 6th – 8th April 2017. We look forward to meeting you at Pragati Maidan Exhibition Center, India at Stand No. 9C08, Hall 9.
Randox Laboratories is a global leader in healthcare diagnostics. We are dedicated to developing solutions that not only meet your needs, but that are of the highest quality, the most reliable and the most cost-effective.
JOIN US FOR LIVE DEMONSTRATIONS
Drop by our stand to receive a live demonstration of our latest products including Acusera 24.7, RX imola and RX daytona+. These will take place at Stand No. 9C08, Hall 9 from Thursday – Saturday.
Reduce time spent troubleshooting and analysing QC data with unique access to instantly updated peer group statistics and automatic calculation of Measurement Uncertainty, Sigma Metrics and Total Error all on one centralised platform.
The RX Series is globally renowned for quality and reliability, teamed with one of the most extensive dedicated clinical chemistry test menus on the market you can benefit from real cost savings through the consolidation of routine and specialised tests on a single platform.
The RX series of clinical chemistry analysers combines robust hardware and intuitive software ensuring unrivalled precision and accuracy for results you can trust.
Committed to advancing biochemistry testing for laboratories. We offer a range of high quality reagents that cover routine and novel markers with applications for use on a wide range of clinical chemistry analysers.
Delivering accurate results, Randox QC provides the complete laboratory package combining true third party controls, calibration verification material, interlaboratory data management software and the world’s largest international EQA scheme – RIQAS.
We’re looking forward to meeting you at CLMA Knowledgelab, booth #338!
Stop by our booth for your chance to check out our Acusera 24.7 Live Online version 2.0. It’s smarter, faster and more powerful than ever before, with unique access to live peer data, accelerating troubleshooting processes and pinpointing the cause of any QC failures. Additional features include the automatic calculation of Measurement Uncertainty & Sigma Metrics, comprehensive charts, bi-directional LIMS connectivity and a complete make-over of our dashboard. Don’t miss your opportunity to see this software live.
Our Randox Consultants will also be on hand to discuss our other products available, which will help you ensure your laboratory produces results you can trust.
Acusera true third party quality controls
As a world leading manufacturer of multi-analyte, true third party controls, thousands of laboratories rely on Randox to accurately assess test system performance and ultimately empower them with the confidence required to release patient test results. With more than 390 analytes available across the Acusera range we can uniquely reduce the number of individual controls required while simultaneously reducing costs, time and storage space. A choice of formats is available ensuring flexibility and suitability for laboratories of all sizes and budgets.
Acusera Calibration Verification
Our Acusera Linearity range has been specifically designed with convenience in mind, helping you to easily meet accreditation requirements. Our liquid ready-to-use verifiers are supplied in varying levels and are available in multiple configurations to meet the specific requirements of individual analysers while challenging the complete reportable range; ultimately ensuring accurate patient testing. All linearity sets are supplied with complimentary data reduction software, providing instant access to reports and real-time peer group data.
Measurement Uncertainty (MU) relates to the margin of doubt that exists for the result of any measurement, as well as how significant the doubt is. For example, a piece of string may measure 20 cm plus or minus 1 cm, at the 95% confidence level. As a result, this could be written: 20 cm ±1 cm, with a confidence of 95%. Therefore, we are 95% sure that the piece of string is between 19 cm and 21 cm long.
Standards such as ISO 15189 require that the laboratory must determine uncertainty for each test. However, they have not specified how this should be done.
How do we calculate Measurement Uncertainty using QC data?
Employing your QC data to calculate uncertainty makes several assumptions; your test system is under control, the patient samples are treated in the same manner as your controls and gross outliers have been removed. If you choose to use your QC data to calculate this you should ensure that you use a commutable control with a matrix similar to that of a patient sample, with analytes present at clinically relevant levels
To calculate MU, labs must look at the intra-assay precision and inter-assay precision of their test.
Intra-assay precision: Sometimes known as ‘within run’ precision, is where 20 or more replicates of the same sample are run at the same time, under the same conditions (calculated from a single experiment). Intra-assay precision helps to assess systematic uncertainties
Inter-assay precision: Sometimes known as ‘between run’ precision, is where 20 or more replicates are run at different times – e.g. 1 replicate every day for 20 days (can be calculated from routine IQC data). Inter-assay precision can help identify random uncertainties within the test system.
*The Australian Association of Clinical Biochemists (AACB) recommends that at least 6 months’ worth of QC data are used when calculating the inter-assay precision1.
Once the data is collected, you must calculate the standard error of the mean (SEM) of the intra-assay precision (A) and the SD of the inter-assay precision (B) in order to measure the uncertainty (u). Once A and B have been calculated, they need to be squared, added together and the square root of the sum found:
As uncertainty is calculated as SD and 1SD is equal to 68% confidence on a standard Gaussian curve, we can conclude that if we multiply using a coverage factor of 2, we can attain 2SD confidence of 95%. This is known as the Expanded Uncertainty (U):
What is the Advantage of Measurement Uncertainty for a lab?
Labs need to carry out MU as it is a requirement of ISO 15189. It states: “The laboratory shall determine measurement uncertainty for each measurement procedure, in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty”.
MU also helps determine whether the difference between two results is negligible due to uncertainty or significant due to a genuine change in condition of the patient; giving labs a greater confidence in reported results.
How can Randox help?
Our new Acusera 24.7 Live Online software provides automatic calculation of MU, saving valuable time and helping labs meet ISO 15189 requirements with ease.
Contact firstname.lastname@example.org to find out how your lab can benefit from Acusera 24.7 Live Online
Ubicados en Europa, la misión de Randox Control de Calidad es la producción de materiales de alta calidad que ayuden a racionalizar los procesos de control de calidad, además de ayudar a ahorrar tiempo y dinero a cualquier laboratorio, independientemente de su tamaño y presupuesto. Gracias a nuestra extensa oferta de productos, en los que se incluyen controles internos de tercera opinión, un software para la gestión de datos inter laboratorios y una amplísima variedad de Programas de Evaluación Externa de Calidad (PEEC), podrá obtener una visión completa del rendimiento de su laboratorio.
Al ser uno de los mayores fabricantes de controles auténticamente conmutables, ofrecemos soluciones para el control de calidad económicas, de la más alta calidad y diseñadas para la evaluación de los resultados de las pruebas de los pacientes. Con nuestra gama de controles Acusera podrá controlar lo que hasta ahora le supondría hasta 4 controles diferentes con un único vial Acusera, que junto con nuestra estabilidad sin igual y la elevada vida útil, le ayudarán a ahorrar tiempo y dinero. Además, las concentraciones son clínicamente relevantes, garantizando la precisión y fiabilidad de los instrumentos a lo largo de toda la variabilidad clínica.
Acusera 24.7 le permitirá obtener resultados más precisos y reducir el tiempo que implica la supervisión e interpretación de los datos del control de calidad. Además, tendrá acceso a una gran variedad de funciones como a los datos del grupo par actualizados en tiempo real y el cálculo automático de la Incertidumbre, el Error Total y las Métricas Sigma. Con Acusera 24.7 podrá asegurar la calidad de sus análisis a través de la resolución más rápida de los problemas mediante esta plataforma centralizada.
RIQAS es el Programa de Evaluación Externa de Calidad (PEEC) de preferencia, empleado por más de 45.000 participantes en 124 países. Gracias a la frecuencia de los informes, podrá identificar los errores rápidamente, reduciendo la necesidad de realizar repeticiones innecesarias y costosas, haciendo que su laboratorio ahorre tiempo y recursos valiosos.
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 22.214.171.124 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.
Is it possible to compare multiple instruments on a single Levey-Jennings Chart?
With Acusera 24•7 users can combine multiple instruments, as well as analytes and QC lots on a single chart. This will enable comparative performance assessment and facilitate immediate visualisation of any ongoing or emerging trends. It may also be useful for troubleshooting out of control QC events.
Is it possible to compare different levels of control on a single Levey-Jennings Chart for identification of concentration related bias?
Yes data for multiple QC lots can be displayed on a single, convenient Levey-Jennings chart allowing any concentration related problems to be identified quickly.
How often is peer group data updated?
With Acusera 24•7 Live Online, peer group data is uniquely updated live in real-time. The instant nature of the peer data will help reduce time and money spent troubleshooting, re-running QC samples and performing any instrument maintenance. With real-time peer group data you can compare to other laboratories around the globe using the same lot of QC material and identify if there are any issues and whether they are unique to your lab or a widespread issue.
Is there a limit to the number of users?
There is no limit to the number of concurrent users – you can have as many as you want. There are 5 different levels of user access – Admin, Group Co-Ordinator, Manager, User and Technical Support. It is worth noting that User access can be customised per user to ensure access to only the required functionality
How can the software help me to meet ISO 15189:2012 requirements?
Unique to Acusera 24.7 Live Online, our software will automatically calculate Measurement Uncertainty (UM) and provide your laboratory with a printable report that can be used to help meet ISO 15189:2012 accreditation requirements. In addition to this the software can help to prevent the release of patient results in the event of a QC failure for example when the Quality Control rules are violated.
Is it possible to use RiliBAK as my allowable limits?
QC data can indeed be rejected or alerted based on RiliBAK guidelines. Other options are also available, including, CLIA, Biological Variation, RIQAS TDPA and user defined performance limits.
Can I purchase Acusera 24.7 Connect without Live Online?
This is unfortunately not possible. Acusera 24.7 Connect is an additional add-on to Acusera 24.7 Live Online that will facilitate automated entry of QC data. To get the benefits of Acusera 24.7 Connect you will be required to participate in the Acusera 24.7 Live Online interlaboratory program.
Is Acusera 24.7 Live Online secure?
To authenticate users, a number of security measures are used, including; participant number, username and a password combination (for individual role-based accounts). Password complexity standards are enforced on user account setup. CAPTCHA is enforced after several failed login attempts to prevent or guard against automated attacks. HTTPS and X509 certificate authentication is in place meeting industry security standards.
I have never used interlaboratory software before, is there training provided with my purchase of 247?
There are a number of different options available in terms of training. The easiest, most convenient and accessible form of training is through the use of our walk through demo that has voice-over and text so everyone can follow. With our software comes a user guide, this is a walk through that laboratories can use to guide them through the usage of the software. Additionally, there is also the possibility of a live demo from the sales consultant in your area who will be able to run through the software with you.
Can I create unique login credentials for each user?
Yes, each user will have their own personal log-in. If a lower level user, e.g. user, technical support or manager forgets their password they can have it reset by the administrator. However, if a group co-ordinator or admin forgets their password they should contact Randox directly who will be able to reset their credentials and resend to the administrator’s email address.
I currently use non-Randox Quality Controls, does this affect the ability of the software?
Not at all, our software is so flexible that it can be used with any other manufacturers Quality Control material. However, you will only have access to the internal functions of the software and will not have access to peer group statistics. For this reason we recommend the software is used alongside our Acusera true third party Quality Control solutions.
Is Acusera 24.7 Live Online the only software option available?
Yes this is the only option available – Unlike other manufacturers there is no need for any additional software packages or options. All functionality is available in the one software package.
My computer is very old, do I need a new, modern and up-to-date operating system to run the software?
Not necessarily. As long as you have stable access to the internet you can access Acusera 24.7 Live Online as it is a cloud based software.
My patient data is confidential. Will the software need access to this data?
Acusera 24.7 will not require access to your patient data. This is important for a laboratory but less for the software. Acusera 24.7 will only need access to the results of your Quality Control to ensure that your instrument/s are performing to standard and therefore ensuring that your patient results will be reliable and accurate.
I have forgotten my username and password – what do I do now?
If an individual with user level or manager level access forgets their username and password, they should contact the laboratory administrator. If an administrator or group co-ordinator forgets their username or password they should contact Randox who will verify the administrator and send new login details for the account.
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.
I need to renew my license, is this done automatically?
If your licence has expired and you would like to renew you should get in touch with your local Sales Consultant.
My internet connection isn’t great. Will this affect the running of the software? What happens if the signal drops when entering results?
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.
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.
Al-i-quot: An amount that is an exact divisor of the whole quantity of a substance (Collins Dictionary of Medicine, R. Young, 2005).
Why aliquot QC material?
Aliquoting QC material can extend the open vial stability of a lyophilised control, according to manufacturer recommendations. By splitting your QC material into a number of tubes and freezing these you can extend the working stability of the control, ultimately reducing wastage and the amount of money spent on unnecessary additional controls.
A laboratory purchases a lyophilised QC with a volume of 3ml once reconstituted the control is stable for 7 days at 2-8oC. However, the laboratory only uses 1ml of this control per week, meaning that 2ml could potentially be wasted. The manufacturer states that the control can be frozen after reconstitution, extending the working stability from 7 days at 2-8oC to 30 days at -20 oC to -80oC. The following outlines the process for aliquoting reconstituted material and extending the control’s working stability.
Aliquoting reconstituted material
- Reconstitute the QC material according to the manufacturer’s instructions.
- Using a micropipette aliquot the required volume (generally a minimum of 0.5ml should be used) of reconstituted material into a tube.
- Repeat step 2 until all the reconstituted material has been aliquoted.
- Label each tube with the date the material was reconstituted to avoid the use of expired material.
- Store each aliquot at -20oC in a frost free freezer. Be sure to check the kit insert for frozen stability claims.
- Remove and thaw each aliquot as and when required making sure to use all material within the frozen stability period.
- Once thawed do not refreeze, dispose of any leftover QC material.
Aliquoting reconstituted material is an ideal way of extending the control’s open vial stability. This will ensure that your laboratory minimises the amount of QC material wasted and saves money by eliminating the need to purchase additional controls. Please note that not all lyophilised controls can be frozen like this. To ensure the controls you are selecting are suitable for aliquoting check the product’s kit insert or contact your supplier.
What can Randox Quality Control offer?
We have a number of lyophilised controls which can be prepared and stored in this way across our extensive product portfolio. To find out more visit www.randoxqc.com or contact us via email@example.com to arrange a visit from one of our QC Consultants.
Drive for more accurate results in your laboratory
We’ve all been there, you’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. What do you do? In reality, we all know that the problem is unlikely to correct itself, especially if it’s a calibration or analyser issue. Human error is a potential factor, however all possible causes must be eliminated to proceed with patient testing.
What’s the solution?
ISO 15189:2012 recommends that a laboratory should “have a procedure to prevent patient results in the event of a quality control failure”. Implementing an interlaboratory data management program which features peer group reporting can help you meet this requirement and monitor the results you are producing. Such programs can help detect errors in the analytical phase of patient testing, through the automatic application of pre-programmed QC rules, thus alerting staff to failed results.
Why must Peer Groups be a feature?
A peer group is defined as a “Community in which most or all members have roughly the same characteristics…” (Businessdictionary.com, accessed 2017). In this instance the characteristics could refer to the; instrument, test method or QC material in use. As such peer group programmes could help you detect errors in your laboratory by comparing your results to those who are employing a similar method, instrument and QC to what you are using, i.e. comparing apples for apples. Therefore it is essential that the peer group data you require is available in real-time, to ensure you are accessing the most up-to-date data when reviewing your patient test results.
Take the example from the introduction. You’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. As part of your troubleshooting procedures, you are able to compare your results to the results of your peer group and note that this is an isolated incident. Consequently, you have eliminated a widespread problem with the QC, reagent or calibrator and narrowed down the root cause to one of the components in your test system. Thus saving you time in the troubleshooting process.
Benefits of Peer Group Comparison
There are a number of benefits to employing peer group comparison in your laboratory. Peer group data comparisons facilitate faster troubleshooting, helping you identify whether the problem you are seeing is unique to your laboratory, or if other laboratories are reporting the same issue. If other laboratories are reporting the same issue it is possible to conclude that there is a widespread problem with either the QC, reagent or calibrator. On the other hand, if it is not occurring within your peer group you will have to investigate further, reviewing your QC processes. As a result, you could resolve issues much quicker by eliminating either a supplier or laboratory issue. Furthermore, you can also eliminate the need for unnecessary repeat tests or instrument maintenance, saving both valuable time and money.
Other characteristics you should look out for
Whilst peer group comparison is a useful feature there are a number of other features you should consider when selecting the right interlaboratory data management program for you. These include;
- Automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics
- Multiple laboratory management on a single platform
- Accessing data anytime, anywhere via PC, laptop or tablet via a web-based platform
- All data charts you may require to assess whether any bias or imprecision issues are present
- Ability to combine data for multiple QC lots, analytes and instruments on a single Levey-Jennings or Histogram chart
- Automated data import via a direct connection to your LIMS
What can Randox offer?
At Randox we are passionate about quality control and believe in producing high-quality material that can streamline procedures for laboratories of all sizes and budgets through our Randox Quality Control brand. Acusera 24.7 Live Online is just one aspect of our extensive laboratory portfolio that has been designed to help you produce results you can trust. With Acusera 24.7 Live Online you can drive for more accurate results by monitoring and interpreting QC data online, anytime, anywhere. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 will ensure analytical quality.
Reviewing QC data can be an extremely time consuming and costly process. With manual statistical calculation laboratories risk missing or ignoring significant trends in QC data which could potentially put patients at risk. So how does a laboratory combat this? Simple; participate in an interlaboratory data management program that provides a quick, effective, accurate and detailed analysis of QC results. The answer to this program is Acusera 24•7 Live Online.
Acusera 24•7 Live Online
With the launch of Acusera 24•7 Live Online version 2.0, QC data review is now faster and simpler than ever before. Our program aims to save the laboratory precious time and money by instantly flagging any QC failures, ultimately ensuring accurate test system performance.
Designed to complement and be used primarily with our Acusera range of true third party controls, Acusera 24•7 Live Online has two primary functions; 1) management and interpretation of IQC data and 2) rapid and effective troubleshooting of QC failures via access to instantly updated worldwide peer group statistics.
These two functions have one common goal – being an effective tool for evaluating laboratory performance. With the launch of version 2.0 the software boasts even more functionality than before, ensuring any laboratory employing Randox Quality Control coupled with Acusera 24•7 Live Online will see benefits from the get-go.
Why should you use Acusera 24•7 Live Online?
Using Acusera 24•7 to help speed up the review process in your laboratory can reap dividends. The program has been designed for this specific reason and the features are geared towards helping the laboratory review, interpret, and analyse QC data quickly, effectively and accurately. One such example of this is the unique dashboard function which instantly flags any alerted or rejected results from the past 7 days, significantly reducing the time spent analysing reports and charts whilst simultaneously allowing any corrective action to be taken immediately with minimum disruption to the lab’s output.
Previously, peer group statistics would have been updated every 24 hours with Acusera 24•7 Live Online version 1.6, however, with the new release, peer data is about to get a unique upgrade. Gone are the days when you will have to wait 24 hours to get updated stats – Acusera 24•7 Live Online now has the ability to generate peer data live in real-time, thereby enhancing the laboratory’s troubleshooting capabilities and allowing labs to compare their data with others around the globe. What’s more there is no deadline for submission of results meaning labs can get a true reflection of performance at any time. Ultimately, laboratories will be able to easily identify if an issue is unique to them or a widespread issue amongst their peers. Such information will allow them establish a root cause quicker and spend less time troubleshooting.
The capacity to generate interactive charts and comprehensive reports automatically is a feature included in Acusera 24•7 that will aid quick review of QC data. Reports can be generated for a user-defined date range and provide a wealth of information. Reports include statistical analysis, statistical metrics, measurement uncertainty, exception and audit trail reports. Reports coupled with Levey-Jennings, Histogram and Performance Summary charts enable rapid and stress-free performance monitoring. The ability to add multiple instruments, QC lots and analytes to a single chart allows for comparative performance assessment and immediate identification of any trends.
We must not forget that Acusera 24•7 Live Online has already had a modernisation in the past few months. In November 2016 we announced the automatic calculation of Measurement of Uncertainty, Total Error and Sigma Metrics. These new features are also included in the version 2.0 launch of our Live Online program.
Our software is highly flexible with custom configurations of performance limits, multi-rules and target values designed to meet and exceed every laboratory’s needs.
With the ability to identify trends, system errors, minimise false rejections and bridge the gap between IQC and EQA, there really is no reason to look elsewhere for your analytical performance of QC.
For more information on Acusera 24•7 Live Online or our Acusera third party controls, click here.
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’.
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