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.
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.
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.
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
The future of diagnostic healthcare has been unveiled at the Randox Science Park in Antrim, as the company’s annual global distributors’ conference gets underway. Delegates from more than 90 countries are taking part in the world-leading healthcare firm’s three-day event at the Hilton Hotel in Templepatrick.
As well as discussions about developments in reagents and quality control products, participants enjoyed demonstrations of Randox’s patented Biochip Array Technology and its extensive range of analysers from the RX Series.
Melansha Fernando from Alpha and Omega Diagnostics in Sri Lanka said,
“Randox has released so many new products recently that laboratories in my country are increasingly interested in what it can offer. As a result I felt it important to come here to learn more about the new technologies. The truly global nature of the company has been impressed upon me after meeting colleagues from so many different countries – I’m delighted to have been able to take part.”
Speaking at the conference, Dr. Peter Fitzgerald said,
“All exporters are aware of the considerable challenges we must overcome in order to do business in the global market but year on year our teams across the world have helped to drive our success. One of the biggest challenges Randox faces is the one we put to ourselves, to deliver truly transformative technologies and improve health worldwide. We recently celebrated our £1 billionth sale and we now look to build on that achievement and accelerate our rate of growth. All of our profits go straight to either R&D, or the development of our infrastructure, so strong growth is key to our goal of revolutionising diagnostics and saving lives across the world.”
Susan Hammond, Global Reagents Sales Manager said,
“It is a pleasure to see the diversity of our distributors gathered together in one room, and recognize how far we have come as an international company. We dedicated Thursday to focusing on building relationships with our worldwide distributors to ensure that they attain the best product knowledge available. Over 100,000 end users employ Randox products and every second of every day 80 Randox tests are used across the world, and it is vital our distributors are kept up to date with every new development.”
For more information on the Distributors’ Conference contact Amy in our PR Team by calling 028 9445 1016 or email email@example.com