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.
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.
Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.
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.
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.
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”.
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.
Six Sigma is a method of process improvement which focuses on minimizing variability in process outputs. The Six Sigma model was developed by Motorola in 1986, and Motorola have reportedly saved over $17 Billion due to its successful implementation.
The model looks at the number of standard deviations (SD) or ‘sigmas’ that fit within the quality specifications of the process. In the laboratory, the quality specifications relate to the Total Allowable Error (TEa). The higher the number of standard deviations that fit between these limits, the higher the sigma score and the more robust the process or method is. As sources of error or variation are removed from a process, the SD becomes smaller and therefore the number of deviations that can fit between the allowable limits is greater; ultimately resulting in a higher sigma score.
A process with a sigma score of six is considered to be a high quality process, making six the target for many industries including the clinical laboratory.
In order to achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. In a Laboratory context, this would equate to 3.4 failed QC results per million QC runs.
Sigma is calculated using the following equation:
Sigma = (TEa – %Bias) / %CV
TEa – Total Allowable Error
%Bias – Deviation from the target or peer group mean
%CV – Imprecision of the data
Why is Six Sigma useful in the laboratory?
Six Sigma can be used to help answer one of the most commonly asked questions in laboratory quality control. How often should I run QC?
The Six Sigma model allows laboratories to evaluate the effectiveness of their current QC processes. Its most common use is to help implement a risk-based approach to QC, where an optimum QC frequency and multi-rule procedure can be based on the sigma score of the test in question. The performance of tests or methods with a high sigma score of six or more may be evaluated with one QC run (of each level) and a single 1:3s warning rule. On the other hand, tests or methods with a lower sigma score should be evaluated more frequently with multiple levels of QC and a multi-rule strategy designed to increase identification of errors and reduce false rejections.
The below table shows how multi-rules and QC frequency can be applied according to Sigma Metrics:
|Sigma Score||QC Frequency||Number of QC Samples||QC Rules|
|6 or more||Once per day||Each level of QC||1:3s|
|5||Once per day||Each level of QC||Multi-rule strategy|
|4||At least twice per day||Each level of QC||Multi-rule strategy|
|< 4||At least four times per day||Each level of QC||Multi-rule strategy|
It is important to note that this is just an example and it may be necessary to run QC samples more often than three times per day. Some high throughput laboratories prefer to run QC samples before and after a set number of patient samples, while others opt to run QC samples after a set period of time. Whatever frequency you choose it is vital that the frequency is appropriate for the test in use. Download our guide ‘How often is right for QC’ to find out more.
What can Randox offer?
Randox’s Acusera 24.7 Live Online is a peer group reporting software application designed to complement the Acusera QC range. The intuitive and user-friendly software boasts some of the most advanced features on the market, and Version 1.6 provides automatic calculation of sigma scores for individual assays, giving the user an at-a-glance overview of assay performance.
Peer group reporting software is an integral part of any modern laboratory seeking to streamline their QC processes and reduce costs. With Acusera 24.7 Live Online, there has never been a better time to implement, save and succeed.
Contact us today to find out how Randox can help your laboratory achieve its goals.