Meeting ISO 15189:2012 Requirements for Multiple Instruments
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.
Cocaine on the Rise
Newly emerged figures from Public Health England have documented that the UK’s current approach to drug treatment has failed to reduce drug related deaths. With UK drug abuse now at an all-time high, 2017 saw a 23% increase in treatment presentations for crack cocaine use, according to The Conversation. An additional article by the Business Insider UK reported that seizures related to cocaine in Britain are now at their highest since 2008.
Crack cocaine is a powerful stimulant designed to temporarily speed up the mind and body. Freebase cocaine (powder cocaine) and crack cocaine (rock form cocaine) can both be smoked to reach the brain quicker, whilst snorting the substance causes a slower effect. A very addictive substance, cocaine is reported to make a user over confident and careless with risks including, breathing and mental health problems, depression and the risk of an overdose related death. When taken in conjunction with alcohol the dangers of cocaine are increased, as the mixture produces the toxic chemical, cocaethylene.
The Conversation highlighted “Cuts to drug treatment budgets are extremely shortsighted. Not only do effective services save lives, they reduce the spread of blood-borne viruses, including HIV. About half of people who inject drugs have hepatitis C. Getting them into treatment is an essential part of plans to eliminate the disease.” At Randox Toxicology we offer the most comprehensive drugs of abuse test menu across multiple matrices. Our DoA ULTRA panel detects up to 20 targeted drugs, offering the largest cross-reactivity profile of over 240 analytes, including Benzoylecgonine/Cocaine. Benzoylecgonine is the most common metabolite measured in urine drug screens to detect cocaine. Using our revolutionary Biochip Array Technology, Randox Toxicology provide cutting-edge multiplex testing capabilities for rapid and accurate drug detection from a single sample.
The price of cocaine has fallen by 13% since 2007 according to Business Insider UK. Price trends in addition to new and emerging UK supply routes have made the drug more appealing and readily available. Whilst the average age group using cocaine is 35 years old, a 30% increase has been seen in young people under the age of 25 years old. A rise which has not been witnessed in a decade.
The increase of cocaine use has shown how vital drug treatment is in responding to the ever-changing market, with services needing to adapt quickly to the needs of varied groups. Amidst the ongoing cocaine problem, Randox Toxicology are leading the way in developing new tests through significant research and development.
For further information on how Randox Toxicology are fighting drugs of abuse, email info@randoxtoxicology.com
We Are Randox | John Fitzgerald wins Ulster University awards for Master’s degree project with Randox
Here at Randox, we’re proud of the talented and innovative teams we have at all our sites. One of our talented engineers at Randox Teoranta recently won a prize for his final year university project in collaboration with Randox. John Fitzgerald, an Electronic Design Engineer, was presented with two awards from Ulster University on Thursday 7th December 2017 – the Civica Prize for excellence in his final project and the Institute of Engineering Technology Prize for achieving the highest grades in his class.
We caught up with John to hear all about it;
A very well done on your awards, John! Tell us about your final project for which you won the Civica Prize.
Firstly it is important to note that my final year project was conducted in conjunction with Randox Teoranta. Without the support, resources and encouragement from the exceptional Research & Development Engineering team here in Dungloe, my project would not have been such a success.
My final year project centred on the design of an industry-standard compact dry bath incubator, designed for the heating and cooling of small volume samples. With a simple and compact design, broad and precise temperature range, the intended use of the product was for bench-top laboratory incubations. The design also incorporated innovative, yet modest, capacitive touch pad controls and a digital display to provide confident temperature selection and accuracy.
This design project required design capabilities in three core engineering disciplines, electronic, embedded and mechanical engineering.
Were you surprised to learn you’d won an award for the project?
Yes, definitely! I was surprised when I received an email at the end of November, informing me that I was to receive the award. I can recall the quality of projects that were on show so this was a complete surprise to me.
I invested a great effort in this project and I’m proud of the personal and academic goals I’ve attained, however, the works achieved would not have been possible without the generous investment of advice from various different sources. I wish to take this opportunity to express my genuine appreciation and thanks to them all.
Thank you to Randox – the industrial knowledge and resources they provided for this wrk added significantly to the quality and relevance of my project to the real world. A special word of thanks, too, should also be afforded to my final year supervisor in Ulster University for the consistent academic support he delivered throughout the course of this MEng final year project.
Did you always want to be an engineer?
To be perfectly honest, the answer to this question is no. I was very uncertain for a long time what career I wanted to pursue as a secondary school student. I was never really exposed to the engineering profession and the wide variety of career paths it can lead to so engineering wasn’t something I immediately thought of when I was thinking of careers I would enjoy.
My father has a lot to answer for though – he was a tool-maker by trade and he instilled a significant interest in engineering and basic electronics in me, and is probably one of the primary reasons I felt a career in electronic engineering was the correct path for me. I decided to apply for my university placement year at Randox Teoranta in the Electronic Engineering team.
After just a few months in to my placement at Randox Teoranta, I knew I had made the correct career choice. I was Randox Teoranta R&D Engineering’s first university placement student, and that I could live at home in Donegal for the year and still receive a first class industrial experience.
How did you find your placement year at Randox?
My placement experience at Randox Teoranta was first class. I was afforded every opportunity to develop and grow my engineering skills. As my competency grew, so did my responsibilities and the complexity of jobs afforded to me.
The team of engineers in Randox Teoranta are exceptional professionals and provided excellent guidance to me as a young student engineer. The work I was tasked with was challenging and relevant and a considerable amount of the work I contributed to, remains in some form in the final Misano analyser that is manufactured today in Dungloe.
I cannot stress enough how important my placement year at Randox Teoranta was for me upon returning for my final two years of university. It provided me with a clear career path and I discovered a passion for Printed Circuit Board Design that I would not have been exposed to, if it were not for this placement.
I was extremely grateful to be offered a graduate position during my placement year on completion of my degree. This security made my final two years at university much more comfortable and also allowed me to discuss with the company the potential to complete my final year project in conjunction with Randox Teoranta. The opportunity to continue my learning and professional development as part of such a progressive and diverse engineering environment was an easy decision to make. As an added bonus, I am able to live at home, in the most beautiful part of the country and engage in an extremely rewarding and challenging profession in my field of study all at the same time. I consider myself very fortunate.
Tell us what a typical day is like in your role as Electronic Engineer.
One of the reasons I enjoy being an Electronic Engineer with Randox Teoranta to such a high degree, is the same reason that makes this question quite difficult to answer.
It is hard to categorise a typical day in my role as an Electronic Engineer in Randox Teoranta. I spend my time on a wide variety of duties or tasks depending on the design needs of the engineering team. I could be spending my time designing circuit schematics for new PCB designs, I could be producing the printed circuit board layout of designed circuit schematics, I could be testing new sensors, electronic parts or manufactured PCB’s to verify their performance, I could be engaging in verification and validation work for a new analyser, I could be engaging in the formation of critical design reports, the list can go on and on.
As the cliché goes, “every day is different”, something which is definitely applicable in this scenario.
What advice would you give to young people considering visiting the Randox Teoranta open day on Fri 22nd December?
I would encourage any young person with a remote interest in a career in Science or Engineering to attend the open day on Fri 22nd December. I believe they will be surprised as to the wide variety of professions and opportunities available at their doorstep.
A conversation with an experienced professional could ignite a spark which could provide clarity as to what they would like to pursue in further education, and in turn professionally. This is an opportunity I wish I was afforded as a young person growing up in rural Donegal, and I consider it an opportunity not to be missed for young people with a genuine interest in these exciting professional fields.
From all the staff at Randox, congratulations to John on this fantastic achievement. We look forward to seeing the pioneering engineering work you will continue to be part of in the future.
The Randox Teoranta Open Morning is on Friday 22nd December 2017 from 10am – 2pm at Randox Teoranta, Meenmore, Dungloe, Co. Donegal.
To find out more tel: +353 7495 22600 or email: randoxpr@randox.com
Pictured with John Fitzgerald (centre) is Dr. Robert McMurray, course director for MEng Engineering at Ulster University (left), and Angela Canavan, Managing Director of Civica who was present to award the Civica prize (right).
Mythbusting: Frequency of EQA Reports
External Quality Assessment (EQA) is a vital aspect of laboratory testing and is often a regulatory requirement. The primary function of EQA is to provide the laboratory with an indication of test system accuracy through interlaboratory comparison. Ultimately participation in an EQA programme will give the laboratory greater confidence in the accuracy and reliability of the results they release.
When choosing an EQA scheme there are a variety of different options. It is important that laboratories weigh up the pros and cons of each option in order to choose the scheme that best suits their needs.
Many EQA schemes promote the distribution of multiple EQA samples per challenge or testing event as a benefit to the laboratory. By analysing multiple samples at each testing event, laboratories believe they are challenging their test system across a wider range of concentrations than would be possible if they were to analyse just one sample. However, this is not always the case as in many instances the levels can be very similar. Another consideration is the EQA report received by the laboratory. EQA reports are used to assess analytical performance and identify any test system failures, such reports can take more than one month to receive. In such instances it would be more beneficial if the laboratory tested just one sample at each bi-weekly/monthly challenge and received their report faster.
Report frequency should be priority for any laboratory when choosing an EQA scheme. A fast turnaround time will allow any test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab. Perhaps the most important benefits of a rapid report turnaround is cost and time savings as it will significantly reduce the time and money spent re-running patient samples.
If the time between sending EQA results back to the organizer and receiving an EQA report is too long, it becomes more difficult to pin-point exactly when an error was encountered thus increasing the possibility of incorrect test results and possible misdiagnosis. While this would be considered the worst-case scenario, it is still a possibility.
Choosing an EQA provider that delivers both frequent analysis and a quick report turnaround will give the laboratories the confidence they need to report patient test results.
With the Randox International Quality Assessment Scheme (RIQAS), comprehensive reports are available within 72-hours of the submission deadline. Furthermore both bi-weekly and monthly analysis options are available.
To find out more on RIQAS and our extensive product portfolio, comprising 32 programmes, visit our page – http://www.randox.com/riqas-external-quality-assessment/ or alternatively contact us using the button provided.
The Importance of a Workplace Substance Misuse Policy
What is a workplace substance misuse policy?
Many organisations implement a policy that outlines the expectations they have concerning the misuse of drugs and/or alcohol and how this can affect performance and safety in the workplace. This can often be referred to as a substance misuse policy.
Employers hold the responsibility to ensure employees are fully aware of the company’s rules, regulations, testing and disciplinary procedures. Fundamentally, this is to guarantee complete workplace safety. The policy itself holds a vital importance providing employees with the knowledge of the standards expected of them in the workplace.
To ensure transparency of information, it is imperative that the policy is written in a clear, comprehensive manner. This should allow them to understand without confusion or misinterpretation the implications the organisation has in place for users who misuse substances.
Why is this policy so important for businesses to implement?
Alcohol and / or drug use increases the chances of problems occurring in the workplace. For example, studies have found that employees with alcohol problems are 2.7 times more likely to have an accident whilst at work.
Some of the main issues that associated with substance misuse in the workplace are:
- Absenteeism – It’s estimated that there are 17 million lost days of work per year due to substance misuse.
- Low productivity levels – Employees may lose focus in different tasks and become de-motivated.
- Inappropriate behaviour – Some cases of substance abuse may lead to inappropriate actions or in extreme cases crime
Evidence suggests that many people who suffer from alcohol and drug abuse are in employment. Studies show that 25% of registered drug addicts are in full-time employment and that 3.3% of all adults in England and Wales aged 16 – 59 classified as frequent users.
Significant issues such as these provide growing concerns for employers to put in place a workplace substance misuse policy to guarantee the welfare of all stakeholders. Under the Health & Safety Act 1974, employers have a duty to ensure the safety of their employees is met to all principles. Introducing an effective workplace policy is a key part in maintaining these standards.
The importance of a workplace policy for drugs and alcohol can benefit employers by:
- Building relationships with employees by showing them there is support available.
- Policies can raise awareness of issues in the business and can encourage staff members to take action if they feel they have a problem.
- Its importance can reduce the number of sick employees, it can also increase staff turnover & productivity levels.
- Employers who implement a workplace policy can also see a rise in efficiency, improved staff relationship, communication and improved corporate image and in some cases customer relations.
What we at Randox Testing Services can do:
Randox Testing Services is a market leader in the drug and alcohol testing industry. Our expertise is relied upon by safety-critical companies all over the world. We provide complete drug and alcohol testing solutions to a range of blue chip companies across multiple industries including aviation, transport, construction, maritime, retail and occupational health to name a few.
Our expert consultancy service allows employers to create an effective drug and alcohol misuse policy. We offer comprehensive advice, guidance and support in composing an effective policy and explaining best procedures and testing methods to use. We also provide assistance to employers with an existing substance misuse policy, helping to modify existing documents to ensure they are legally viable and can withstand challenge in court.
To ensure clear communication of any policy changes, our experts can come to your workplace and present the policy to your staff. By having a third party explain the policy employers can ensure all the benefits are communicated effectively. This way staff do not feel like they are being victimised or persecuted, but know their employer is looking after their workplace wellbeing.
Combining our consultancy service with our drug and alcohol testing service and / or point of care products, employers can find a complete testing solution from Randox Testing Services.
For more information on our products and services call +44 (0) 28 9445 1011, email, testingservices@randox.com or visit our website www.randoxtestingservices.com
About Randox Testing Services
At Randox Testing Services we offer complete drug and alcohol testing solutions to a wide range of industries across the globe. We work with companies to help create and implement effective workplace testing policies that suit their needs and budget.
To support our customers our additional services include training and education courses as well as policy reviews and consultancy. Our experts are at hand to discuss any testing requirements you may have. To get in touch email testingservices@randox.com today.
The Global Burden of Obesity
Obesity is a condition where a person has abnormal or excessive fat accumulation that presents a serious risk to health. This December, Randox are highlighting the health implications of this potentially deadly condition, especially throughout the midst of this festive season when it is all too easy to overindulge in fatty foods and sugary treats!
Worldwide obesity has almost tripled between 1975 and 2016, with over 650 million adults and 340 million children being recorded as obese in 2016 alone, highlighting that the prevalence of the condition is rapidly rising. Randox are dedicated to improving health and increasing the awareness and prevention of obesity and its consequences.
What are the causes and consequences of obesity?
With more people around the world adopting sedentary lifestyles and the increasing consumption of foods high in sugar and fat, there is a higher risk of an energy imbalance between calories consumed and calories expended, which is the fundamental cause of obesity. This increases the risk of a number of diseases such as cardiovascular disease, diabetes, musculoskeletal disease and some forms of cancer, with each condition having detrimental effects to your health.
One of the more serious consequences of obesity is type 2 diabetes mellitus (T2DM), where a resistance to insulin is developed causing blood sugar to rise higher than normal. This can lead to serious, long-term problems such as kidney damage, cardiovascular disease and blindness.
How are Randox supporting the battle against the world’s obesity crisis?
Through extensive investment in R&D, we are able to offer cutting-edge diagnostic tests to assess the risk of obesity-related diseases before they occur!
Randox offers the unique adiponectin test to assess the risk of developing T2DM. Low adiponectin levels have also been linked with the risk of developing other pathologies including metabolic syndrome and cardiovascular diseases. The adiponectin test is applicable to both patients with diagnosed clinical obesity, and those deemed to have a ‘healthy’ BMI through a condition known as ‘abdominal obesity’.
This is because while it is widely recognised that people who are overweight or obese are at higher risk of developing T2DM, you don’t have to be overweight to be at risk of developing diabetes. When abdominal visceral fat is stored further underneath the skin and accumulates around major organs, a condition known as abdominal obesity, it greatly increases the risk of developing T2DM. When abdominal visceral fat levels become increased, adipocytes which secrete the protein hormone adiponectin become reduced; this reduces the anti-inflammatory and insulin-sensitising properties of this powerful hormone.
The adiponectin test is available for use on hundreds of clinical biochemistry analysers, and can also be run on our world leading RX series range of clinical chemistry analysers. Find out more here: www.randox.com/obesity/
Our world-renowned quality control products help ensure the accuracy of obesity-related testing!
When diagnosing and monitoring obesity-related complications such as cardiovascular disease (CVD) and T2DM, it is vital that laboratories have a robust quality control system in place to ensure the accuracy and reliability of the results produced. This is especially true considering, 70% of medical decisions are based on a laboratory test result.
It is estimated that over 90% of T2DM is related to obesity. When monitoring diabetes, glycated haemoglobin (HbA1c) levels in the blood provide an indication of average blood glucose levels for the previous 3 months. It is therefore important that the chosen quality control will effectively challenge the test system across the patient reportable range, as an inaccurate result at the cut-off could mean a patient does not receive appropriate diabetes treatment. Our Acusera Liquid HbA1c control provides clinically relevant levels, not only helping to ensure accurate instrument performance but maximising laboratory efficiency. Find out more here: www.randox.com/obesity/
Obesity prevention
Thankfully, for those deemed to be at risk, obesity and related illnesses are largely preventable through engaging in regular physical activity (60 minutes daily recommended for adults), limiting energy intake from total fats and sugars and increasing the consumption of fruit and veg, whole grains and nuts. Knowing your risk allows you to stay in control of your health throughout this festive season!
Further to our clinical lab tests, our Randox Health clinics offer heart health, metabolic health and diabetes health testing as part of our Everyman, Everywoman and Signature packages to identify and assess risk of developing obesity-related diseases. Our clinics utilise the same cutting-edge tests and quality control that we have available to clinical laboratories globally, as well as our patented Biochip Array Technology (BAT).
For more information about our clinical diagnostic range of obesity-related products, visit www.randox.com/obesity/
Mythbusting: āUsing IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
Got a question?
Give the Gift of Health this Christmas with Randox Health
Showing you care comes in many different packages.
This year, you can give the ‘gift of health’ to someone you love, through a Randox Health Gift Card.
Randox Health has the most comprehensive health screening programmes in the world, as well as a wide range of specialised tests. The Everyman, Everywoman and Signature programmes carry out up to 350 tests. That means your results deliver a complete understanding of your health: your heart, kidneys, thyroid, fertility, bones and more. And it doesn’t just tell you how you are now, but helps you to manage your health for the future.
Each one of our programmes lasts for twelve months and include personalised health plans, a private consultation with an expert and repeat testing. This unique aspect enables you to see exactly what impact you’re making on your health as you follow our recommendations.
Specialised testing is also available on areas including cardiac health, coeliac autoimmune disease, hormonal health and genetic testing.
The programmes are available at our clinics in London, Holywood and Crumlin, and also through our innovative mobile health clinic. Gift cards can be purchased from as little as £20.
To find out more and purchase the most thoughtful of Christmas presents – a gift card for the ‘gift of health’ – click here.
To book a health screening at a Randox Health clinic in Crumlin, Holywood or London, please call 0800 2545 130.
For further information please contact the Randox PR Team by emailing randoxpr@randox.com or phoning 028 9442 2413
The Importance of External Quality Assessment in HIV Enzyme Immunoassay Testing
Introduction
Quality Control (QC) is vital for the clinical laboratory in order to ensure the accuracy and precision of patient test results. Without a robust QC strategy, test system errors could go undetected, potentially resulting in misdiagnosis and inappropriate/delayed patient treatment.
QC can be divided into two main components; Internal Quality Control (IQC) and External Quality Assessment (EQA).
What are IQC and EQA?
IQC is used in the daily monitoring of test system precision and reproducibility. IQC essentially compares the internal laboratory’s performance over time, highlighting any deviations from ‘normal’ performance. While IQC is a good method of testing performance, it is not always robust enough to detect calibration errors or issues associated with ‘wide’ acceptable limits.
In an External Quality Assessment (also known as Proficiency Testing, or PT) program the EQA provider will deliver ‘blind’ samples to all EQA participants. The use of such ‘blind’ samples ensures EQA can be used to measure a laboratory’s bias and accuracy. These samples are analysed by the lab and results are returned to the EQA provider for analysis. The data are examined, means and SDs are calculated, and any outliers are highlighted. Reports are then generated and delivered to each participant, giving a summary of performance in comparison to the rest of the participant group.
Why Should Laboratories Carry out EQA Testing?
The World Health Organisation (WHO) recommends that a robust QA program should be implemented in any lab which carries out HIV testing, and Internal and External quality control should be carried out on an ongoing basis1.
Participating in a rigorous and robust EQA scheme is a requirement of ISO 15189. All labs seeking ISO 15189 accreditation need to be part of an EQA scheme which appropriately challenges their test system.
The Cost of Poor Quality EQA
The most common method of HIV detection is to utilise Enzyme Immunoassay (EIA) antibody testing2. EIA tests are highly sensitive and can be optimised for automation, facilitating high-volume testing. However, with higher volumes of testing comes a higher probability of error. With EIA assays, the most common error encountered is false positive results2.
False positive results have a number of implications. Any screen-positive results must be verified using a confirmatory test; usually a Western Blot assay. The Western Blot is much more labour intensive and expensive than EIA tests, and is not efficient enough for high volume testing2. Therefore, if a laboratory is producing a higher than average number of false positive results due to poor quality assurance practices, they will ultimately spend significantly more time and money on confirmatory tests.
How can EQA Improve HIV Testing Accuracy?
The main use of EQA is to verify the accuracy of laboratory testing. Accuracy refers to the closeness of the obtained result to the ‘true’ value. As EQA is tested using ‘blind’ samples, operator bias is eliminated and the test system can be appropriately challenged.
EQA can also be used as a means of detecting deficiencies with IQC. For example, some IQC providers supply assayed IQC material with very wide acceptable limits, with 2SD often +/- 20% from target value. For this reason, labs may believe their performance is good, but when scrutinized by EQA with narrow acceptable limits, performance will be identified as substandard.
What to Look for in a Good EQA Scheme
Laboratories can join either Local, National or International EQA schemes. An International EQA scheme would provide the best return on investment due to the higher peer group size and more diverse demographic of participants. Some key factors which typify a good quality EQA scheme include:
- Accreditation to ISO 17043 – Being accredited to this standard ensures the EQA scheme is fit for purpose
- Frequent Distribution – Regular EQA analysis allows for rapid identification of errors and any necessary corrective actions can be taken as soon as possible
- Large Number of Participants – Ensures an extensive database of results for a range of analytical methods and instruments. In addition, larger participant groups increase statistical validity of results
- Clinically Relevant Ranges – Analytes should be present at both normal and abnormal ranges, as to ensure medical decision limits are adequately tested
- Comprehensive Reports – Much of the value of participating in an EQA scheme lies in the report generated by the provider. Reports should be comprehensive, providing a range of statistical metrics and charts
How can Randox Help?
The Randox International Quality Assessment Scheme (RIQAS) incorporates all the above features, as well as many others, into the world’s most comprehensive EQA scheme. With more than 45,000 participants worldwide, RIQAS offers unrivalled peer group comparison, and has earned its place as the most popular EQA scheme in the world.
Conclusion
An EQA scheme operates like an early warning system; it can alert the lab and document the need for, stimulate and monitor improvement. However, the improvements themselves must be implemented and maintained by the lab.
Investment in a good EQA scheme can save labs a substantial amount of time and money, so it is worthwhile to invest wisely.
To sign up for RIQAS or to learn more, sign up using the form below!
References
- World Health Organisation, Laboratory Methods For Diagnosis Of HIV Infection In Infants And Children. Geneva: World Health Organisation. 2010;5.
- Fearon M. The laboratory diagnosis of HIV infections. The Canadian Journal of Infectious Diseases & Medical Microbiology. 2005;16(1):26-30.
Drink and Drug Drive Limits UK and Ireland
As part of Randox Testing Services‘ ongoing efforts to raise awareness around issues related to drugs and alcohol we will be running a drink and drug drive campaign in the first two weeks of December. This campaign will detail the different drink and drug drive limits across the UK and Ireland and highlight how these limits differ from border to border.
Drink Drive Limits UK & Ireland
As can be seen in the table below, the drink drive limits across England, Wales and Northern Ireland are the same whereas Scotland has a lower limit. In December 2014 the limit was reduced in order to bring Scotland in line with most other European countries. The drink drive limit in the Republic of Ireland is the same as Scotland.
| General Public | |||
| Breath | Blood | Urine | |
| Ireland | 22µg | 50mg | 67mg |
| Scotland | 22µg | 50mg | 67mg |
| Rest of UK | 35µg | 80mg | 107mg |
*Value is volume of Alcohol per 100ml of Sample
The limits above apply to the general public, however across Ireland lower limits have been set for professional drivers:
| Professional Drivers | |||
| Breath | Blood | Urine | |
| Ireland | 9µg | 20mg | 27mg |
*Value is volume of Alcohol per 100ml of Sample
In the UK the Railways Transportation Safety Bill was passed introducing these lower limits for HGV drivers, pilots, train drivers etc. This bill is active in England, Wales and Northern Ireland. Ireland replicated the UK by introducing this in Ireland’s Road Traffic Act 2010. Scotland currently don’t have regulations in place so the drink drive limits are the same regardless of occupation.
Drug Drive Limits UK & Ireland
Section 5A Road Traffic Act was passed in the UK on 2nd March 2015 which requires only the presence of drugs above a specified limit can provoke criminal proceedings against a driver. Roadside swab tests are currently being utilised across England, Wales and the Republic of Ireland.
Roadside tests are used to detect the presence of four different types of drugs, the main two being cannabis and cocaine. The roadside tests only show a positive or negative reading that identifies traces of these drugs in the users system. If traces are shown, a blood sample is taken to identify the limit of the substance in a person.
If a roadside test doesn’t pick up traces of a substance an arrest can still be made if police have strong concerns that a driver may be under the influence of a substance they cannot detect at roadside. A blood sample is then taken for a more in-depth analysis to see if there are any drugs in the drivers system. The Scottish Government won’t have roadside testing put in place until 2019. It is still illegal to drive under the influence of drugs in Scotland and arrests can still be made.
Unlike alcohol, there are no separate drug drive limits for the general public and professional drivers:
| Drug Driving Limits | |||
| Cannabis | Cocaine | Heroin | |
| Ireland | 1µg | 10µg | 5µg |
| England and Wales | 2µg | 10µg | 5µg |
*Values are amount of substance per 1 litre of blood
The Scottish Government confirmed drug-driving limits and roadside testing will be introduced in Scotland in 2019. Currently in Scotland and Northern Ireland it is illegal to drive if impaired by drugs and when police suspect a motorist of drug-driving, they carry out a field impairment test.
This method is still used in the UK and Ireland for drivers under the influence of other drugs not picked up in a swab test. If the individual fails this they can be arrested and taken for a doctor’s examination to see if the person is impaired to the extent that they are unfit to drive. Then a blood sample is taken to prove if these drugs are in their system.
For more information on these limits follow us on Twitter @RandoxTesting to avail of the information and resources we will be sharing over the first 2 weeks in December.
You can also access our download wall which includes a range of educational posters, brochures and resources by visiting http://www.randoxtestingservices.com/downloads/
About Randox Testing Services
At Randox Testing Services we offer complete drug and alcohol testing solutions to a wide range of industries across the globe. We work with companies to help create and implement effective workplace testing policies that suit their needs and budget.
To support our customers our additional services include training and education courses as well as policy reviews and consultancy. Our experts are at hand to discuss any testing requirements you may have. To get in touch email testingservices@randox.com today.
