Pursuing Perfection: Insights into Global IQC Practices
In a time when medical laboratory personnel are pushed to their limits, internal quality control and quality management are easy to consider a nuisance. However, these processes are vital to ensure accuracy and precision in the potentially life-saving tests performed in these laboratories. Most High-to-middle-income countries have strict regulations governing quality procedures in medical laboratories, but global standardisation in these areas is lacking. Over 70% of clinical decisions are based on laboratory testing but many clinicians are unaware of the accuracy and precision limitations associated with many of these tests. This places the responsibility on laboratory staff to ensure that all results provided to clinical decision-makers are as true as possible. For this, they rely on IQC and a robust quality management system.
To determine the state of the industry, a report by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) surveyed over 100 IFCC full and affiliate members, receiving responses from 46 countries1. This survey consisted of a series of multiple-choice questions in relation to quality practices in their respective countries.
Findings by IFCC Task Force on Global Laboratory Quality
90% of respondents indicated that quality standards are in use in their country, despite being mandatory in only 46.7% of those countries.
These responses are encouraging showing that at least some level of predefined QC practice is implemented even in countries that do not legislatively mandate the inclusion of quality standards. This also hints that in those countries where it is not mandatory, it may soon become a requirement to adhere to a specified QC system. Nevertheless, in countries where regulatory measures are currently absent, the rigour of the implemented quality control procedures may not be adequate to ensure the accurate reporting of results.
42.5% of respondents indicated that IQC was not run in all laboratories in their country.
These respondents indicated that IQC is run in 50-99% of laboratories in their country. This less encouraging result shows that minimum IQC practices are not implemented globally. However, due to the multiple-choice nature of this survey, it is difficult to determine how drastic this issue is. Although it does raise the question of how these laboratories verify the precision of their results.
66.7% of respondents indicated that they use assay manufacturer quality control material.
This refers to first party quality control materials which are optimised by the manufacturer for use with a specific assay, instrument or method. These controls are often manufactured from the same material as the calibrator, making them less sensitive to subtle changes in performance, allowing them to mask weaknesses in the assay in question and therefore should be considered less effective options than third-party controls. Additionally, ISO15189:2022 encourage the use of third-party controls and require laboratories seeking accreditation that do not use third party controls to provide a sufficient explanation as to why this is the case.
60% of respondents indicated that not all laboratories in their country had written IQC policies and procedures.
This highlights an important aspect of a quality management system. Without written IQC policies and procedures it is almost impossible to standardise the IQC process and corrective action across laboratory staff, never mind on a national scale. Drafting this documentation can be cumbersome, however, many organisations can be contracted to assist with the drafting and implementation of these procedures for laboratories seeking to gain accreditation.
28.6% of respondents reported that manual interpretation of the IQC data was normal practice.
Manual data interpretation also poses challenges to the standardisation of IQC processes. Written IQC policies and procedures are crucial in implementing standard acceptance criteria for IQC results. Manual data interpretation also implements restrictions on the ability to carry out more advanced statistical analysis of the QC data.
The implementation of robust IQC practices is crucial for ensuring the trueness and precision of the results produced by a laboratory. Used correctly, IQC can monitor variability caused by instrumentation and lot changes as well as various other sources of analytical error. ISO15189:2022 provides a thorough framework for designing rigorous IQC policies and procedures, highlighting key areas such as the use of third party QC material, levels of QC material, the frequency at which IQC should be completed, matrix composition, acceptance/rejection criteria and non-conformance procedures. For more information on ISO15189:2022 accreditation, take a look at our educational guide ISO15189:2022 Updates.
The results from this survey conducted by IFCC show a clear disparity between IQC processes around the globe, displaying differences in requirements, recommendations, and legislation. Standardisation of IQC is not without its challenges. However, by striving to achieve the highest possible levels of quality, and following the guidance laid out in ISO15189:2022, laboratories can be confident in the results they provide to clinicians.
Acusera Quality Control
The Acusera range offers unbiased, independent third party quality controls for medical and research laboratories of all shapes and sizes. Our assayed controls are provided with target values for most commercially available analysers, ensuring that your test menu will be covered. With enhanced stability, commutability and consolidation, all our controls are manufactured to provide a clinically relevant challenge to your test method, aiding in ISO15189 accreditation. For more specialist laboratories, our teams are happy to discuss your requirements and help to provide bespoke quality control material, providing an extremely flexible QC range.
Designed for use with the Acusera range of third party controls, the Acusera 24•7 software will help you monitor and interpret your QC data. Access to an impressive range of features, including interactive charts, the automatic calculation of Measurement Uncertainty & Sigma Metrics and live peer group data generated from our extensive database of laboratory participants, ensures Acusera 24•7 is the most comprehensive package available. For laboratories performing manual review of their IQC data, Acusera 24•7 provides a comprehensive yet easy-to-use platform for advanced statistical analysis and monitoring of these data.
- Wheeler SE, Blasutig IM, Dabla PK, et al. Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies. Clinical Chemistry and Laboratory Medicine (CCLM). 2023;0(0). doi:10.1515/cclm-2023-0492
Sandwell Council partners with Randox Health to launch free health checks service
Sandwell Council initiative places prevention at the centre of healthcare
Thousands of eligible Sandwell residents are being offered diagnostic NHS Health Checks to detect any early signs of diabetes, heart and kidney disease and hypertension.
The early identification of individuals with the potential to develop these conditions will enable the NHS to intervene and, in many cases, prevent the onset of potentially life-changing and life-threatening illnesses.
In a pioneering initiative, the Sandwell tests and online self-assessment provision will be provided by a partnership comprising the council’s Healthy Sandwell team, the NHS and diagnostics company Randox Health – whose tests and clinics will be used to facilitate the innovative testing. Tests and clinics will be available for Sandwell residents in both Sandwell and, if convenient, in Birmingham.
The awarding of the contract to Randox Health to provide the tests follows an open tender process by Sandwell Council. The company has demonstrated success in providing 17 million PCR tests to NHS Test and Trace during the Covid-19 pandemic, helping prevent thousands of hospitalisations and deaths in the UK.
Free tests will be offered to Sandwell residents aged between 40 and 74 who have not previously suffered coronary heart disease, strokes, diabetes or kidney disease. Each will, in the next few weeks, begin receiving letters inviting them to the 20-minute NHS check, with branding from Randox, Healthy Sandwell and the NHS. The letter will include a link to the Randox website through which the tests can be booked.
Sandwell residents who have not yet received a GP letter and believe they are eligible can visit the Randox website https://nhshealthcheck.randox.com, take an eligibility check and then book their own appointment.
Tests will be carried out by specially trained staff at a number of community pop-up clinics in locations in Sandwell such as leisure centres and community spaces, aiming to reach those most at risk of having an undiagnosed serious illness.
Tests for Sandwell residents will also be available at Randox Health’s Birmingham Clinic (39-40 High Street, B4 7SL).
Test results will be made available to GPs for inclusion on patient medical records through Health Diagnostics Ltd, a third-party provider. Randox will hold none of the data from the test results.
Not only will the testing programme enable prevention and mitigation through the early identification of serious illness, it will also allow lifestyle modification on issues including smoking, alcohol and weight management.
Councillor Suzanne Hartwell, Sandwell Council’s Cabinet Member for Adults, Social Care & Health, said:
David Ferguson, Chief Operating Officer for Randox Health said:
1. Sandwell Council
Sandwell Council will participate in the partnership through Healthy Sandwell, which is part of the council’s Public Health team. Healthy Sandwell provides a range of services to support local people to make positive lifestyle changes, such as quitting smoking or losing weight. Further information: https://www.healthysandwell.co.uk/
2. Randox Health
Established in 1982, Randox is the largest healthcare diagnostics company from the UK and Ireland.
Undertaking research, development, manufacture and distribution of innovative laboratory tests and analysers, Randox provides 15% of all worldwide cholesterol tests and 10% of all clinical chemistry tests. More than 5% of the world’s population (over 370 million people) receive medical diagnosis using Randox products each year.
Randox Health focuses on the provision of timely and accurate testing to identify risk to health, improve clinical diagnoses and promote preventative healthcare; aiming to achieve better healthcare outcomes whilst reducing the burden on clinical services.
In early 2020 Randox recognised the threat from COVID-19 and quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UK’s National Testing Programme and private clients. Randox has processed more than 25 million gold-standard PCR tests for the National Testing Programme and private COVID testing for travel.
Randox Health is clear that better diagnostics are unquestionably critical to future improvements within healthcare and is committed to remaining at the forefront of that field.
Its growing network of High Street clinics now operate in 20 locations around the UK and Ireland, including Birmingham.
Randox was established in 1982 to address the need for accurate and readily available diagnostic tests to improve patient diagnosis. Around 70% of all medical decisions are based on laboratory results, and so, not surprisingly, we believe that earlier, more accurate and more accessible diagnostics are the key to improving global health and saving lives.
And yet, until now, in spite of their contribution to clinical decision making, and the important role they play in patient outcomes, diagnostic tests have only accounted for 2% of the UK’s national health budget.
But things are changing. What was once a little-understood industry, working diligently behind-the-scenes, has quickly become an area of interest and relevance to just about everybody, given the key role the sector has played during the COVID-19 outbreak.
Whilst regrettable that it has taken a pandemic to bring the health diagnostics sector into focus, it is a positive step forward for healthcare that the huge national and international scope of our sector is now rightly acknowledged.
Click the links below to hear from a range of clinicians, pathologists and public officials on the importance of diagnostics, and from our customers on their experience of Randox testing technologies.
Want to know more?
Contact us or read the latest news on Randox.
What We Do
Staff Newsletter April - June 2019 Edition
We are delighted to be able to share with you the Q2 2019 edition of our We Are Randox staff newsletter!
Click here for a range of company and staff news from April to June 2019 – including photographs from the Randox Health Grand National 2019 and all our staff fundraising for AWARE NI and Mind Your Mood.
** Please note that image links work most efficiently in your Google Chrome browser**
A dramatic increase in global consumption of antibiotics has led public health experts to call for innovative new ways to rein in excessive use of the drugs, following a study by the Centre for Disease Dynamics, Economics and Policy, in Washington DC.
The study found a 65% rise in worldwide consumption of antibiotics from 2000 to 2015, despite efforts to encourage more prudent use of the drugs. The unrestrained use of antibiotics is the main cause of the increasing appearance of drug-resistant infections, which now kill more than half a million people worldwide. A report in 2014 predicted that the spread of drug resistance could claim millions of lives per year by 2050.
Eili Klein, an author of the study, which was published in Proceedings of the National Academy of Science, criticised the global response to the global antibiotic resistance crisis as “slow and inadequate” and called for a “radical thinking” of antibiotic consumption.
At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which will help to reduce the unnecessary prescription of antibiotics. Earlier this year, Public Health England reported that 59% of people who visited their GP with a sore throat were prescribed antibiotics, in spite of only 13% actually needing them.
The new Randox swab test indicates the cause of the infection and whether a patient needs antibiotics or not, by rapidly detecting and identifying the cause of 21 respiratory infections in just 5 hours
The test assists the clinician in prescribing the appropriate antibiotic.
John Lamont, Lead Scientist at Randox Laboratories, said;
“Current diagnostic testing for respiratory infections takes at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way our new respiratory test can.”
This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics. It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.
This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes. By reducing the prescription of unnecessary antibiotics, we can limit their use only for when they are truly needed.
The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.
Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.
For further information about the Randox Respiratory Infection Array please contact the Randox PR team by email: email@example.com or phone 028 9442 2413