Fabricado en Europa – Randox Control de Calidad
Fabricado en Europa – Randox Control de Calidad
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 gestión de datos interlaboratorios
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.
Take steps to prevent incorrect patient results by making one simple change
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 5.6.2.2 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.
Acusera 24•7 Frequently Asked Questions (FAQ’s)
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, 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 , 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.
Is Acusera 24.7 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 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 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.
Pancake Tuesday 2017
As it’s Pancake Tuesday, we at Randox QC wanted to share one of our recipes with you for the perfect pancake. What better way to do this than to create our very own IFU especially for today! Click the link below to download the IFU and celebrate Pancake Tuesday with us.
*Note: this IFU was created with humour in mind. Please ensure you follow the correct procedures in place in case of a fire or other emergencies.*
Randox Quality Control – More than EQA
Did you know that Randox is the company behind the RIQAS EQA scheme? RIQAS (Randox International Quality Assessment Scheme) is just one area of our comprehensive Quality Control portfolio. As such it is our resolution this New Year to introduce Randox as the brains behind RIQAS and show you that we are more than just an EQA provider by sharing our passion for laboratory QC.
Who are Randox Quality Control?
At Randox we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With our extensive product offering comprising third party QC sera, interlaboratory data management software and calibration verification products, you can be sure that our complete QC solutions will provide you with a comprehensive overview of laboratory performance.
Seeing the complete picture with Randox QC
Acusera QC sera
As one of the largest manufacturers of true third party, commutable controls we deliver high quality, cost effective quality control solutions designed to accurately assess instrument performance and provide confidence in patient test results.
Acusera 24.7 interlaboratory data management
Acusera 24.7 enables you to drive for more accurate results by helping you to monitor and interpret QC data. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 ensures analytical quality.
RIQAS EQA Scheme
RIQAS is employed by more than 45,000 laboratory participants in 124 countries. With frequent reporting you will identify errors sooner ultimately reducing the need to carry out preventable, expensive retests on a large volume of patient samples.
Acusera Calibration Verification sera and software
The Acusera linearity sets cover a wide range of clinical testing including; cardiac markers, therapeutic drugs and proteins. Designed with convenience in mind, the range ultimately helps you to meet CLIA requirements for calibration verification and the assessment of linearity.
Randox QC Resources Hub
Beyond selling laboratory QC we are also passionate about education, offering a range of educational guides, seminars and webinars, with more to come throughout 2017. Check out our QC resources hub for our current educational material and let us know what educational material you would like to see.
For more information, or to request a visit from one of our QC Consultants, contact us via acusera@randox.com.
We Are Randox | Travis Lai returns home to Malaysia with Randox
Being part of a global company offers endless opportunities including career growth, international travel and the chance to relocate somewhere new and exciting, or to take your job back home!
Travis Lai, one of our business development executives for Randox Quality Control took the opportunity to relocate from London to Malaysia in order to be closer to his family back in December 2015! Read our Q&A below to find out what it’s like to work for Randox and how Travis enjoys being closer to his family and friends.
Hi Travis, can you tell us a little bit about your background working for Randox?
I have been with Randox now for nearly three years working as a business development executive for Randox Quality Control. As part of my role I am constantly developing new sales leads, developing relationships with current and new customers, in charge of distributor management and planning and overseeing new marketing initiatives which all aim to grow the Quality Control division at Randox.
How did you find working in the London?
When I first started working for Randox I was based in the London Wall office. I had been to London a few times before I joined Randox and already knew a few people who were living in London which was nice. London is a very vibrant and multi-cultural city with lots to do and see. It was a big change for me in the beginning as it took me a while to get used to the food and of course the weather! I made sure to buy a raincoat during my first week!
What made you decide to relocate home to Malaysia?
I worked in London from April 2014 to Dec 2015 before I took the opportunity to return home to Malaysia due to a family concern. I had been thinking about it for a while and when the opportunity came Randox approved my application for relocation. I was very pleased that I was given this unique opportunity as it’s quite rare that employees are able to transfer from London to as far as Asia for a job role. But that’s one of the perks working in a global organisation, you get to experience things that you wouldn’t get the opportunity to do so elsewhere– I am extremely grateful that I got the opportunity to move back home for work.
Were you able to continue to work in the same job role once you moved home?
Yes, I was able to continue to work as a business development executive for Randox Quality Control which is great, the only thing that changed was my location.
What do you enjoy the most about being home in Malaysia?
I love being closer to my family and friends here at home, I think that’s probably the best thing for me I missed them a lot when I was living in London. It’s also great to get back to the sunny weather, Malaysia is quite warm all year around so there isn’t much of a need for a raincoat over here and I also love the food. My favourite dish is called Nasi lemak, it is a Malay fragrant rice dish cooked in coconut milk and considered the national dish. In terms of work, it’s useful that I am closer to the end users and distributors. This really comes in handy when I need to get in touch with distributors urgently and I don’t have to worry about time differences.
If you are interested in joining our global team make sure that you check out Randox careers website to see what new opportunities we have for you.
#WeAreRandox
Celebrate Christmas with Randox Quality Control
T’was the week before Christmas and all through the lab not a thing could be heard not even a sound. The analyser lay silent asleep in the corner, the lab staff at home dreaming of a few days’ rest, only a few more days to go before the big day!
The big man in red, what will he bring those who already have everything? Peace, happiness and health for their loved ones throughout the festive break, that would be the wish for everyone to make. And what better way to ensure they stay healthy, well it all begins in the laboratory…
An important consideration to remember when choosing your lab Quality Control (QC) is that approximately 70% of clinical decisions are based on laboratory test results. It is therefore essential that the results gained from laboratory testing are accurate and reliable in order to provide the appropriate treatment and avoid or prevent potential misdiagnosis.
Patient results are of the utmost importance for a laboratory and therefore running the best Quality Control material should be at the top of their agenda. QC material should have a number of features that allow a lab to judge the overall quality of their output. These features include the controls ability to be commutable (which means how well it reacts as a replicate of a patient sample), is it a true third party control that has been manufactured to provide an independent and unbiased assessment of performance, does your control come with clinically relevant levels and does it have a long shelf life as well as a good open vial or reconstituted stability? These are the questions lab staff will be asking themselves when deciding on what QC is the right QC.
So stay off Santa’s naughty list by providing accurate and reliable patient test results, do this by employing Randox QC in your laboratory. Our controls have been designed to deliver significant cost savings without sacrificing on quality. With consolidated controls (combining up to 100 analytes in a single vial) your lab can reduce QC costs and preparation time, the inclusion of analytes present at clinical decision levels will eradicate the need for additional controls and because of our long shelf life (2 years for liquid controls, 4 years for lyophilised) and excellent stability claims your laboratory can be sure that expensive lot changes will be a thing of the past! Our controls can be described as true third party and this, combined with the commutable nature of the controls, leads to us being able to claim that we have the best Quality Control material around.
So this Christmas when deciding what QC to choose – make sure you look no further than Randox Quality Control. Our QC family is known as Acusera and our product offering includes QC and calibrator material, Interlaboratory Data Management Program (Acusera 24.7), the world’s largest international EQA/PT scheme better known as RIQAS and the newest addition to the family, Linearity or Calibration Verification material.
We have packages for every lab regardless of size and budget and we guarantee you will become ho-ho-hooked on Randox QC.
Wishing you all season’s greetings and a prosperous New Year from everyone at Randox QC.
QC Shelf Life – Why is it Important?
An important consideration when choosing your Quality Control material that is often overlooked is the shelf life of the control. With every new lot of control extensive validation studies must be performed. Regulatory bodies such as CLIA require new lot numbers to be evaluated before routine use in the laboratory. For example, CLIA has instructed that any new control lot to be run alongside patient samples will need to be verified alongside the old lot of control. The process is designed to give laboratory professionals confidence in the new material and ensure it is fit for purpose before implementing it in the lab.
As part of the validation process laboratories are required to assay both the old and new lots side by side. The current lot is then used to help verify if the new lot will be acceptable to run within the lab. Such validation studies can be very costly for a lab as well as being extremely time consuming – with some studies taking up to a month to complete! By choosing a control with a longer shelf life laboratories can aim to use the same lot of control for a longer time period. Ultimately this means fewer lot changes and minimal inconvenience for the lab. With a shelf life of 2 years for liquid controls and up to 4 years for lyophilised, coupled with unrivalled stability claims, employing Randox Quality Control in your laboratory will ensure that expensive lot changes will be a thing of the past. Our comprehensive control offering is guaranteed to increase efficiency and reduce costs in any laboratory without compromising on quality.
Contact us today to find out more information on our Acusera range of Quality Controls.
ISO 22870- Are you meeting expectations?
Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.
There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.
POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;
- Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
- Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
- Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
- Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
- Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
- Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
- Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel
In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.
Our Acusera liquid ready-to-use controls include:
- Blood Gas Control– A liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
- Liquid Cardiac Control– This is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
- Liquid Urinalysis Control– Liquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
- Liquid HbA1c Control– This is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.
Complementary EQA programmes are also available to meet the needs of ISO 22870.
IQCP: Where Are We Now?
What is IQCP?
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
Where are we now?
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
Positive Opinions of IQCP
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
Negative Opinions of IQCP
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
ISO 15189:2012 requirements
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.
References:
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Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
