Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’

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Mythbusting: ‘Using 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.

Mythbusting QC Bias
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Westgard’s Great Global QC Survey 2017

In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.

Read on as we take a summarised look at our favourite bits.

Setting control Limits

Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.

Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.

Respondent Map - Westgard QC Survey

The types of Controls used by labs

More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.

Frequency of QC

The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.

The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.

The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.

“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard

QC Frequency Influences

Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.

Managing QC

Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.

Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.

A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.

More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.

Managing QC Costs

Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.

Conclusion

Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.

How Randox Can Help

Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits this is where Randox comes in.

Acusera Third Party Controls offer the highest quality solution for any lab – regardless of size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189 recommendations. Unrivaled consolidation allows for significant cost savings.

Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.

Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results

To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.


Randox Presence at China’s Largest Laboratory Equipment Exhibition Signals Continuation of Growth in Chinese Market

Global health diagnostics provider Randox has maintained its status as a significant competitor in the Asian market by participating in the NCML Exhibition in Hangzhou. The NCLM is the largest laboratory equipment exhibition in China dedicated to the advancement of diagnostic equipment and is an annual staple of the country’s top medical equipment firms. Also attracting some of China’s top clinical science talents, the exhibit was held in the capital of China’s Zhejiang province on 20th September.

In-vitro diagnostic (IVD) equipment, which enables diagnosis and monitoring of samples taken from the body, was the sole focus of the exhibition but an essential aspect of the IVD process is Quality Control. The Quality Control Market is a lucrative one and continues to grow – estimated to be worth $1.04 billion by 2022.

Over many years, Randox has developed the largest global EQA (External Quality Assurance) scheme available on the market, RIQAS, which offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With just under 40, 000 participants in 132 countries and 32 flexible programmes, it is little wonder that the global health technology giant is predicting huge growth in Chinese territories.

Randox has been involved in trade in China for over 20 years and has been making significant strides in the Asian market recently through a strategic Chinese market expansion launch in December 2016. This expansion has included the securing of distributors across four of the largest provinces in China and partnerships with hospitals in Guangzhou, Shanghai and Wuhan.

Preceding the NCML Exhibition, in February 2017, Randox launched a major recruitment drive to hire Mandarin-speaking graduates in Northern Ireland who could join the sales, marketing and scientific teams in China. The company, which employs over 1,400 workers worldwide, was supported by Ulster University and its Confucius Institution in this recruitment campaign.

Ying Zhu, Sales Manager for Randox Laboratories in China, commented on the success Randox has seen in China over the last ten months;

“China is one of our key markets and we were delighted to showcase our capabilities at China’s largest IVD equipment exhibition recently. Randox in China has been growing from strength to strength in the last year, building on a solid foundation laid in 20 years of trade with the country. We continue to increase our presence in the Asian market thanks to increased output from our innovative R&D programmes, and enhanced manufacturing capabilities, including new facilities at the Randox Science Park, our new headquarters in Antrim. These infrastructural developments have resulted in an increasing range of products which we can now offer to growing and dynamic markets such as China. This increasing range of products coupled with a growing market presence has significantly increased our business penetration and subsequent support to customers.”

Margaret Fick, RIQAS Scientist added;

“At our most recent training conference in China, we were very pleased to host several of our newly acquired hospital partners who presented to our audience how many laboratories have benefitted from our Randox Quality Control products. The testimonials from high profile individuals who have experienced the quality, efficiency and reliability of our products is accelerating our growth across China. Our inclusion at the NCLM Exhibition marks another cornerstone in Randox’s expansion in China.”

For further information about NCLM, please contact Randox PR by phoning 028 9445 1016 or emailing RandoxPR@randox.com


Randox launching new product range at leading laboratory medicine event in USA

A group of 30 delegates from global healthcare company Randox Laboratories has this week travelled to the USA, to take part in the world’s largest diagnostics conference – in San Diego, California.

The American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, known as the leading event for laboratory medicine worldwide, is attended by over 20,000 delegates from across the globe, and offers Randox the opportunity to showcase their capabilities and to network with leading healthcare professionals and key decision makers.

Launching at this year’s event are a number of innovative and exciting new products, including a test for Acute Kidney Injury, a revolutionary diagnostic for small, dense low density lipoprotein (sLDL), a subtype of LDL cholesterol which is a vital risk marker for cardiovascular disease, and the latest in laboratory quality assurance software.

Chief Scientist at Randox Laboratories, John Lamont, who is heading up the delegation to the US, commented;

Our very significant investment in research and development means that we have more new tests in development than any other healthcare company in the world.  Each year at AACC we are able to bring a wealth of exciting new technologies to the American market, for a range of the world’s pressing health issues in need of the most urgent address. We look forward to showcasing our latest innovations at this year’s AACC conference, and to identifying further potential projects.”

Dr. Peter FitzGerald, Founder and Managing Director of Randox Laboratories, commented;

“We appreciate that post-Brexit there will of course be particular business challenges with regards to international business, but at Randox we will remain committed to developing new health diagnostic technologies in the areas where they are needed most, and to expanding the business in our key markets, such as the US.

“The USA is one of our most important markets and we have been exporting our diagnostic products there since the early 1980s. We will continue to nurture our presence there, the expansion of which will be supported by our soon to be opened facility in Kearneysville, West Virginia, which will enable us to strengthen our position in that market.”

AACC runs from the 30th July – 3rd August at the San Diego Convention Centre. Randox can be found at booth #3839.

For further information about Randox at AACC please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com


Randox increases exports and secures new business in China

Following the launch of its new Chinese market expansion programme in December 2016, global healthcare diagnostics company Randox Laboratories has made significant strides in its business with China, successfully increasing its exports and enabling new business opportunities within the country.

The firm has just returned from a business trip to China to meet new distributors and customers acquired over the last six months, and to train this recently acquired distributor network on Randox’s latest healthcare technologies, with a key focus on the company’s RIQAS programme, the world’s largest External Quality Assessment scheme for laboratories.

Ying Zhu, Sales Manager for Randox Laboratories in China, commented on the success Randox has seen in China over the last six months;

“China is one of our key markets and although our world-leading diagnostic products have been sold there for more than 20 years, we continue to increase our business presence there thanks to increased output from our innovative R&D programmes, and enhanced manufacturing capabilities, including new facilities at the Randox Science Park, our new headquarters in County Antrim. These infrastructural developments have resulted in an increasing range of products which we can now offer to growing and dynamic markets such as China. This increasing range of products coupled with a growing market presence has significantly increased our business penetration and subsequent support to customers.”

Since the launch of the market expansion programme last year Randox has successfully secured distributors across four of the largest provinces of China and has partnered with key hospitals in Guangzhou, Shanghai and Wuhan.

Margaret Fick, RIQAS Scientist added;

“At our most recent training conference in China, in addition to the educational seminars I conducted with my colleagues, we were also delighted to be able to host several of our newly acquired hospital partners, who presented to our audience of current and potential customers on how their laboratories have benefited from our Randox Quality Control products. The use of testimonials from high profile individuals who have experienced the quality, efficiency and reliability of our products is accelerating our growth across China and this is set to continue over the coming months and years.”

For further information about Randox in China please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com


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

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

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

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

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


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.


How frequently should you run EQA?

There is much debate among clinical laboratories when discussing this common question. With some schemes offering testing as little as 2 times per year, it raises the question, is this really enough?

How frequently an EQA scheme is run will often be dependent on several aspects. Factors such as the diagnostic error rate, number of tests undertaken, experience and turnover of technical staff, and the known stability/instability of the analyte in question should be considered and will all contribute to determine the desired frequency of EQA.

Each EQA programme will vary, where one area, for instance Chemistry, may require bi-weekly testing, another, such as Serology, may only need to be tested every 3 months. Although there is variation between schemes, the benefits of testing more frequently unquestionably outweighs the costs of not testing frequently enough.

Issues with infrequent testing?

If your EQA provider offers infrequent testing, there is likely to be a lengthy period of uncertainty where errors could be happening in the laboratory and consequently incorrect results being released. The outcome of this could be damaging to both patients and laboratories, with credibility and trust in results likely to come under scrutiny. For these reasons, having an infrequent EQA scheme could cause harm to your laboratory and reduce confidence in your test results.

Why should you use a frequent EQA scheme?

To ensure the previously mentioned errors do not occur, laboratories should participate in frequent EQA schemes to guarantee that if incorrect test results do arise, then they will be detected and rectified immediately.

As preventative/corrective actions can be taken sooner through frequent EQA schemes, you will have increased confidence in your test systems performance and may reduce the need for expensive retests. Being able to pinpoint when an error occurred will be much simpler if you are only looking back a matter of weeks or a couple months, as opposed to if you are looking back over a longer period such as 4 to 6 months.

The ability to implement corrective actions sooner and with less disruptions to the lab will help lead to both time and cost savings in the future.

What can Randox Quality Control offer?

Randox International Quality Assessment Scheme (RIQAS), offers bi-weekly, monthly and quarterly reporting options* designed to assist with the early identification of laboratory errors. Not only will RIQAS provide you with extra confidence in test system accuracy, but with 32 flexible programmes you could also make significant cost and time savings through consolidation.

With more than 40,000 participants in 124 countries, RIQAS is the largest international EQA scheme on the market and offers laboratories around the world assurances that the results they are releasing are accurate and reliable. Our many features include; the ability to register up to 5 instruments per programme at no extra cost, easy to read reports, internationally accredited programmes and rapid report turnaround. Why don’t you contact us today and find out how we can support you in maintaining quality control in your laboratory?

*Programme Specific


Demand for external support driving growth of EQA

“In Vitro Diagnostics (IVD) Quality Controls Market” recently published by Markets and Markets has highlighted an overall significant growth within the Quality Control Market. Further growth is anticipated in the coming years with the Markets and Markets report estimating that the IVD QC market will be worth $979 million.

One area that is currently experiencing growth within this sector is the EQA segment, which Markets and Markets estimates to command a 6.6% share of the overall IVD market. The report is crediting growth within this segment to you, the customer, stating “…various end users or customers of IVD quality control products mostly prefer external support to run their quality control activities. For this, market players are largely focusing on providing external quality assurance (EQA) support”. As such companies such as Randox are being approached to provide EQA for a range of small, independent laboratories and large laboratory chains alike.

What other factors have contributed to this growth?

The adoption of ISO15189 and other similar standards is becoming mandatory in many countries, as discussed in a previous blog post. Accreditation highlights the accuracy and reliability of the patient results being released. ISO15189 states that “The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment or proficiency testing schemes”. Therefore laboratory managers are employing EQA programmes in their laboratory to meet such requirements. EQA also enables laboratories to meet other accreditation requirements such as peer comparison and clinically relevant testing.

Selecting the right EQA for you

When selecting the right EQA scheme for your laboratory there are a number of considerations to be made; sample frequency, peer group numbers, report format, report turnaround and so on. According to a survey conducted by Randox Quality Control 55% of respondents listed sample frequency as the most important feature to be considered when selecting an EQA scheme. Sample frequency is an ongoing debate regarding EQA. However, schemes with frequent reporting will allow you to easily pinpoint when an error occurred and implement corrective actions with minimal disruption. Also making the top three key factors in this survey were; quality samples and peer group numbers.

What can Randox Quality Control offer?

As the largest international EQA scheme available on the market RIQAS offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With more than 40,000 participant in 124 countries and 32 flexible programmes we are certain that the external support we offer for your quality control activities will provide you with the upmost confidence in your laboratory’s performance. Furthermore with our programmes accepted by national and international accreditation bodies worldwide employing RIQAS can help you gain accredited status providing your end users with peace of mind. With other benefits such as programme consolidation, rapid report turnaround, easy to read at-a-glance reporting and the ability to register up to 5 instruments per programme at no extra cost why don’t you contact us today and find out how we can support your quality control activity?  

To request a visit from a QC consultant contact us via acusera@randox.com


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