Acusera 24•7 (Edit)
Acusera 24•7 (Edit)
Designed to complement our range of true third party controls, Acusera 24•7 is a live, cloud based interlaboratory data management and peer group reporting software, intended to assist in the management of daily QC activities.
Why implement an interlaboratory program?
- With real-time peer group data, laboratories can instantly compare statistics to other labs using the same lot of QC material.
- Acusera 24•7 boasts a unique dashboard, allowing for instant identification of any QC failures over the past seven days and alerts of product expiry.
- Automatically calculate %Bias, Total Error and Sigma Metrics, enabling enhanced performance assessment and improved QC strategy design.
- Acusera 24•7 generates Levey-Jennings, Histogram and Performance Summary Charts for efficient performance monitoring.
- Designed to speed up the review process, our comprehensive range of easy-to-read reports include: Statistical Metrics, Uncertainty of Measurement and Audit Trails.
- Automated upload of QC data direct to Acusera 24•7 via LIMS and Middleware is available. This function eliminates the need for manual data entry further increasing efficiency.
- Software flexibility allows laboratories to configure their own performance limits, multi-rules, consensus groups and target values for each instrument or QC lot.
- This cloud based software is available for laboratories to access anytime, anywhere therefore eliminating the need for installation, software maintenance and frequent back ups.
Why implement an interlaboratory program?
Randox International Quality Assessment Scheme (RIQAS)
RIQAS is the world’s largest External Quality Assessment scheme with more than 47,000 laboratory participants spanning over 139 countries
Why Choose RIQAS?
- Our rapid, user-friendly reports allow at-a-glance performance assessment. Complimentary multi-instrument, inter-laboratory and end-of-cycle reports are also available.
- The availability of large peer groups ensures robust data is available for a wide range of instruments and methods.
- Consolidate EQA analysis, reduce workload and costs with our comprehensive, multi-parameter programmes.
- Frequent reporting allows early identification of test system errors, while our 72 hour report turnaround enables corrective action to be taken with minimum disruption to the lab.
- Flexible programme options are available to suit all laboratory budgets. The option to register up to 5 instruments per programme at no extra fee further reduces costs and facilitates comparative performance assessment.
- RIQAS.net is a convenient, cloud based data entry system which allows participants to return results and view reports online.
- RIQAS programmes are accepted by national and international accreditation bodies including ISO 17043:2010 – “Conformity Assessment – General Requirements for Proficiency Testing”.
- EQA samples are manufactured to the highest quality standard and span clinically relevant levels. A commutable sample matrix increases confidence that performance mimics that of patient samples.
RIQAS EQA Programmes
Choice & flexibility are guaranteed with our 33 programme portfolio.
Browse the programmes below
RIQAS EQA Reports
User-friendly, one-page per parameter reports allow for at-a-glance performance assessment.
Browse the reports below.
Ideal specifications of an EQA provider
External Quality Assessment retrospectively assesses performance against other laboratories using the same method and instrument, by analysing “blind” samples as if they were patient samples. Results are frequently submitted for statistical analysis, following which each lab will receive an overall comparative report. Find out why EQA is important here.
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RIQAS Point of Care
Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres, RIQAS Point of Care provides independent evidence of the accuracy and reliability of test results. Randox International Quality Assessment Scheme (RIQAS) is the world’s largest EQA scheme with over 47,000 participants in more than 139 countries.
Why RIQAS Point of Care?
About RIQAS Point of Care
How it Works
On a monthly basis we will distribute an identical sample of blood to all participating sites. Each participating site will test the sample in the same way they would test a real patient sample, then return their test results to RIQAS within a set time. The scheme is unique in distributing whole blood samples rather than serum based samples, this ensures that samples act identically to real patient samples at the point of care.
An electronic report is then sent to participants, comparing their results with other participants using the same analyser. Satisfactory and unsatisfactory performance is represented using a traffic light system, allowing instant identification of any issues. A more detailed breakdown of performance may be obtained if further information is required. With time, an overall picture will emerge showing whether results are consistently accurate and reliable or whether there may be an underlying analyser and/or operator issue.
Tests and Analysers
Test Role HbA1c • Diagnosing diabetes mellitus
• Monitoring treatment
• Encouraging self-managementTotal Cholesterol & HDL Cholesterol • Risk factors for heart disease
• Monitoring lipid lowering therapyC-Reactive Protein (CRP) • Early detection of infectious disease
• Identifying need for antibiotic treatmentGlucose • Diagnose and monitor diabetes
• Monitor for the presence of hypoglycaemia
(low blood glucose) and hyperglycaemia (high blood glucose)International Normalised Ratio (INR) • Used to measure the effect of anticoagulant
drugs such as warfarin
• Help diagnose a bleeding disorder; to help
estimate the severity of liver diseaseKetones • To determine whether excessive ketones are
present in the blood, to detect diabetic
ketoacidosis (DKA)Note – The RIQAS Point of Care range is constantly expanding to include new tests and analysers. Please contact us if your desired analyser or test is not currently displayed.Ordering Information
Panel Catalogue Number Lipids RQ9181/A Lipids + 1 panel RQ9181/B Lipids + 2 panels RQ9181/C Additional Sample RQ9181/D What Participants Say
Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:
“All in all a quick and efficient service”
“Good online system”
“Very helpful team”
“Excellent training”
“They are an experienced team”
“Very satisfied with the service that we receive”
“Very good value for money”
“The website is great”Distribution Dates
Distribution Month Sample Distributed Result Submission Deadline March 2020 2nd March 11th March April 2020 6th April 15th April May 2020 4th May 13th May June 2020 1st June 10th June July 2020 6th July 15th July August 2020 3rd August 12th August September 2020 7th September 16th September October 2020 5th October 14th October November 2020 2nd November 11th November December 2020 7th December 16th December Importance of Quality Assurance
Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:Internal Quality Control
Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.External Quality Assessment
External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.
EQA provides assurance to both staff and customers that testing provides accurate and reliable results.Want to know more?
Visit our Importance of EQA page to learn more.
Want to know more?
Contact us or download the RIQAS Point of Care catalogue to learn more.
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Acusera 24.7 Software Update
The latest update of Acusera 24.7 allows RX Imola, Modena and Daytona+ users to import compatible QC files from a configured analyser to Acusera 24.7 without the need for manipulation. This new functionality eliminates the need for manual data entry, therefore effectively reducing the risk of transcription errors whilst speeding up the reporting process.
Acusera 24•7 | Update Features
Our brand new Acusera 24.7 video is here! Take a look now
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Contact us or download our Acusera 24.7 brochure today.
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Quality Controls
RIQAS Past Panels
RIQAS (Randox International Quality Assessment Scheme) is the largest global EQA scheme with over 50,000 participants in more than 139 countries. Our range currently comprises 33 programmes and the majority of clinical testing.
What are RIQAS Past Panels?
Available Panels
• Ammonia/ Ethanol
• Anti-TSH Receptor
• Blood Gas
• BNP
• Cardiac
• Cerebrospinal Fluid (CSF)
• Clinical Chemistry
• Coagulation
• CO-Oximetry
• CYFRA 21-1
• ESR
• Glycated Haemoglobin (HbA1c)
• Haematology
• Human Urine
• Immunoassay
• Immunoassay Speciality 1
• Immunoassay Speciality 2
• Immunosuppressant Drugs
• Lipid
• Liquid Cardiac
• Maternal Screening
• Serology Epstein Barr Virus (EBV)
• Serology (HIV/ Hepatitis)
• Serology (Syphilis)
• Serology (ToRCH)
• Specific Proteins
• Sweat Testing
• Therapeutic Drugs
• Trace Elements in Blood
• Trace Elements in Serum
• Trace Elements in Urine
• Urinalysis
• Urine Toxicology
*Product availability is dependent on RIQAS stock surplus levels.
Benefits of RIQAS Past Panels
All RIQAS Past Panels are provided with an Excel document containing supporting data for the instrument and method of interest.
RIQAS Past Panel samples span multiple levels, making them ideal for ensuring accurate instrument performance across the measuring range.
RIQAS Past Panels allow laboratories to receive comprehensive external QC reports even after program close.
Acusera 24.7
Designed to complement our range of Acusera true third party controls, Acusera 24•7 is a live, cloud based interlaboratory data management and peer group reporting software, intended to assist in the management of daily QC activities.
Why implement an interlaboratory program?
Acusera 24•7 | Key Features and Benefits
Click each icon for full features and benefits
Peer Group Statistics
With real-time peer group data, laboratories can instantly compare statistics to other labs using the same lot of QC material. Data is continuously updated, allowing labs to identify unique and widespread issues to help reduce time and money spent on troubleshooting, re-running samples and performing instrument maintenance.
Unique Dashboard Interface
Acusera 24•7 boasts a unique dashboard, allowing for instant identification of any QC failures over the past seven days and alerts of product expiry. The interface is designed to reduce the time spent analysing data, meaning corrective action can be taken immediately with minimum disruption to laboratory output.
Advanced Statistical Analysis
Automatically calculate %Bias, Total Error and Sigma Metrics, enabling enhanced performance assessment and improved QC strategy design. Reject or alert data based on QC multi-rules or user defined performance limits including Rilibak, CLIA and biological variation. Uncertainty of Measurement (UM) is also calculated, helping meet ISO 15189 requirements.
Fully Interactive Charts
Acusera 24•7 generates Levey-Jennings, Histogram and Performance Summary Charts for efficient performance monitoring. Users can add multiple instruments, parameters and lots to a single chart to compare performance and assess emerging trends. Laboratories can review data for date ranges, explore individual data points and record events.
Comprehensive Reports
Designed to speed up the review process, our comprehensive range of easy-to-read reports include: Statistical Metrics Reports, Uncertainty of Measurement Report, Exception Report, and an Audit Trail Report. Reports can be customised for specific date ranges and filtered to display individual test or instrument data.
Automated Data Import
This optional software allows for automated upload of QC data direct to Acusera 24•7 via LIMS and Middleware. This function eliminates the need for manual data entry, further saving costs and increasing efficiency.
Highly Flexible
Software flexibility allows laboratories to configure their own performance limits, multi-rules, consensus groups and target values for each instrument or QC lot. This software’s internal functions can be used with any manufacturer’s QC material.
24/7 Access
This cloud based software is available for laboratories to access anytime, anywhere therefore eliminating the need for installation, software maintenance and frequent back ups. Access Acusera 24•7 here.
Technical Support
With Acusera 24•7, expert technical support is available from our team of highly trained specialists. Laboratories can remotely access the technical support service for immediate troubleshooting, therefore eliminating the need for on-site assistance.
Want to know more?
Contact us or download our Acusera 24.7 brochure today.
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Quality Controls
Randox International Quality Assessment Scheme (RIQAS)
User-Friendly Reports
Presented in a user-friendly, one page per parameter format, complimentary multi-instrument and interlaboratory RIQAS reports allow comparative performance assessment of all laboratory systems. Each End-of-Cycle report summarises performance compared to the previous cycle, allowing laboratories to identify quality improvement over time.
Large Database of Users
With 47,000 RIQAS participants in 139 countries worldwide, a large peer group means more information is available for a wide range of instruments and methods. This therefore ensures greater accuracy and confidence, while reducing the level of uncertainty in results used for comparison.
Consolidation
Comprising over 360 parameters across 33 comprehensive EQA programmes, RIQAS can streamline external quality assessment by significantly reducing the number of individual programmes needed. Consolidation is guaranteed to save laboratory time and money, with fewer samples to prepare, reports to interpret and number of kits to store.
Report Frequency
Frequent reporting allows early identification of test system errors and implementation of any necessary corrective actions with minimum disruption to the lab, reducing costly errors with patient results. RIQAS offers bi-weekly, monthly, and quarterly options (programme specific), with a turnaround of less than 72 hours for most reports.
Flexibility
With 33 flexible external quality assessment programmes available, RIQAS is suitable for every laboratory. Reduced parameter and reporting options are available for selected programmes, with the ability to register up to 5 instruments per programme at no extra cost this will help save money and facilitate comparative performance assessment.
Result Entry
RIQAS.Net is a convenient, cloud based data entry system which allows participants to return results and view reports online in seconds. Participants can submit results directly into the online RIQAS database, where PDF reports are collated and emailed back to participants. Current and previous reports are available to download at anytime, ideal for on the go users.
Accredited
RIQAS programmes are accepted by national and international accreditation bodies worldwide, including ISO 17043:2010 – ‘Conformity Assessment – General Requirements for Proficiency Testing’. This guarantees high quality programmes that are fit for purpose and assist laboratories in achieving their own accreditation.
Quality Material
Every RIQAS sample is manufactured to the highest standard, spanning clinically relevant levels to allow identification of concentration related biases to ensure accurate instrument performance across the entire analytical range. Designed to be commutable, RIQAS samples are manufactured from human source material and are free from interfering preservatives, increasing confidence that performance mirrors that of patient samples.
RIQAS EQA Programmes
Choice and flexibility guaranteed with 33 programmes available.
RIQAS EQA Reports
User-friendly, one page reports available for each parameter.
*Please note, product availability may vary country to country.
More About RIQAS
What is External Quality Control?
Why Participate in an EQA Scheme?
Ideal Specifications of an EQA Provider
Large participation numbers
Blind samples
Stable and consistent sample matrix
Frequent analysis
International accreditation
Detailed reports
Realistic range of analyte concentrations
Samples react in the sample manner as patient samples
Rapid feedback
Want to know more?
Get in touch or download our full RIQAS brochure
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Point of Care Testing (POCT) Explained
Point of Care Testing (POCT) is the delivery of a test at the point in time at which the result will be used to make a decision and taking appropriate action resulting in an improved health outcome. It is also known as near patient, bed-side, extra-laboratory, decentralised, and ancillary testing [1]. It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment [2].
Point of care testing is not a recent practice; many early diagnostic tests were administered at the bedside. However, analytical technology has progressed and multiple tests can be performed within minutes in a laboratory. Recently, this technology has been put into the hands of the staff near the patients [2]. There are two types of technology, benchtop analysers and hand held devices. Bench top systems are just smaller versions of laboratory analysers but some steps are automated. Hand held devices are simple in appearance but complex internally, they can manage several tasks including, adding reagents, separating cells from plasma, and reading colour or other measures.
Results can be obtained faster, allowing for more immediate decisions meaning treatment can begin sooner. Patients can live a longer and higher quality life, helped by a reduction in the length of hospital stays.
Some benefits of POCT [2]:
Key objective
The main objective of Point of Care Testing is to generate results more quickly so that appropriate treatment can be provided, resulting in an improved patient outcome.
Management
Accurate and reliable results can only be obtained if the patient and sample are treated correctly. Point of care testing is likely to be performed by staff with a limited technical background, so training and quality control are vital.
Outcomes
Proper analysis technique alone is not enough to ensure an accurate decision; any test will only be beneficial if the appropriate action is taken based on the result. The effectiveness of POCT is assessed in terms of the overall outcome of the patient.
There are three phases in the POCT cycle: pre-analytical phase, analytical phase, and post-analytical phase. About 90% of quality issues are attributed to the pre-analytical and post-analytical phases [3]. These errors are mainly attributed to user error and can be caused by a number of issues including, selecting the wrong POCT device, not following manufacturer instructions, inadequate training, not adhering to appropriate QC practices, and many more.
The errors can usually be mitigated by implementing an action plan and ensuring it is executed exactly as designed, deviation from the action plan will lead to errors. Errors in POCT diagnostics can lead to misdiagnosis, improper treatment, costly follow-up procedures, and death.
Some strategies for improvement:
Internal Quality Control and External Quality Assessment is conducted to monitor the stability of the analytical measurement system and to alert the operator to a change that may lead to a medically significant error [6].
A study by Price, Smith and Bruel [8] was conducted on a number of labs over a period of time of up to 15 years. They discovered that test result performance improved with time and was associated with regular participation in External Quality Assessment (EQA) schemes and with the use of internal quality control (IQC) procedures.
Internal Quality Control
Internal Quality Control (IQC) is used to assess the day-to-day consistency of assay performance, providing quality assurance for patient results. IQC activities are among the ten most common POCT deficiencies. These may include performing and documenting quality control testing and taking the correct action for outliers [4]. This poor performance could be attributed to how IQC is viewed in POCT; users may lack appreciation of the potential for errors and may see the analyser as infallible, they likely see IQC as an additional workload as opposed to part of their testing routine.
CLSI regulations require risk assessment for each stage of patient testing alongside an implementation of a quality control plan. Below are some suggestions for how IQC should be conducted for POCT.
Conduct
IQC should be conducted when: a new lot of consumable is used; a patient result is queried; after maintenance; the device has been physically insulted. IQC should be conducted by the usual device operator so assurance can be provided for the whole testing process.
Training
ISO 22870 requires POCT users should be trained in the theory and practice of IQC [5]. Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.
Material
QC material for POCT should be obtained from a third party provider and not rely on material provided by the device manufacturer, the benefits of which are well documented. It should also contain analytes at clinically relevant concentrations, be provided ready-to-use, and be stable at ambient temperatures.
Results
All IQC results must be recorded with the date, time, user, decision to accept or reject, and any actions taken as appropriate. Locally assigned ranges alongside analyte-specific rules should be used to maximise error detection. An example of how IQC could be recorded and an action flowchart can be seen in Fig. A below.
Troubleshooting
There should be a protocol for required actions following a failed IQC. Any troubleshooting should be developed with knowledge of the most common errors and user capability.
Review
A monthly review should be conducted to identify persistent failures and trends.
The cost of IQC may also be a factor in resistance to IQC, however, while it is difficult to quantify, the cost of not conducting it may be greater in terms of human harm. A whitepaper is available detailing IQC in POCT (download).
![Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]](https://www.randox.com/wp-content/uploads/2018/08/Fig.-A.jpg)
Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]. (Click to expand)
External Quality Assessment
External Quality Assessment (EQA) or Proficiency Testing (PT) involves running blind patient-like samples and comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results. (Learn more about EQA)
Benefits of participation in an EQA programme include assessment of result accuracy, assessment over time, comparisons with instruments, methods and peers, and providing confidence in test results.
EQA for POCT is, in theory, similar to EQA in a large laboratory. There is a significant difference however, the POCT participants are usually health care professionals with little knowledge of laboratory medicine. A lack of understanding of the importance of EQA had led to a smaller percentage of sites participating than large laboratories.
A Good EQA Scheme
A good EQA scheme should offer:
Conducting EQA in POCT
Below are some suggestions for how EQA should be conducted for POCT.
Conduct
EQA should be conducted by the operator who normally conducts patient testing to ensure the true workflow is assessed [6].
Material
EQA samples should be commutable, meaning they have the same numeric relationship between measurements procedures as is observed for a panel of patient samples (reacts the same as a real patient sample).
Report Frequency
Challenges / surveys should be frequent enough to identify systematic errors in a timely manner, affecting the fewest patient results [10].
Report Turnaround
A fast turnaround time allows test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab.
Review
A regular review of past EQA results should be part of the cycle of quality.
Guidance
A POCT EQA provider should be able to provide assistance when the user is having difficulties.
Results
Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.
Internal Quality Control
Randox offer a number of controls suitable for Point of Care Testing applications:
Acusera Blood Gas Control
The Randox Acusera Blood Gas Quality Controls contain assayed target values for ten parameters, covering pH, pCO2, pO2, electrolytes, glucose and lactate. The material is provided in easy to open ampoules for added convenience and ease-of-use. The liquid ready-to-use nature of the control makes it ideal for use in point-of-care testing and on a wide range of blood gas instruments.
Acusera Liquid Cardiac Control
The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore, an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.
Acusera Liquid HbA1c Control
Liquid Urine Control
The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2℃ – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.
External Quality Assessment
Randox offers RIQAS Point of Care, a simple EQA scheme designed for use in point of care settings. It is a single sample, single scheme programme featuring whole blood samples for authentic patient sample assessment.
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RIQAS Point of Care
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[1] C. Price, A. St john and J. Hicks, “Point-of-care testing”, 2004. [Online]. Available: http://mldt.hu/upload/labor/document/PRICEP.pdf. [Accessed: 23- Jul- 2018].
[2] C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.
[3] A. Okorodudu, “Optimizing accuracy and precision for point-of-care tests”, Acutecaretesting.org, 2011. [Online]. Available: https://acutecaretesting.org/en/articles/optimizing-accuracy-and-precision-for-point-of-care-tests. [Accessed: 24- Jul- 2018].
[4] H. Holt and D. Freedman, “Internal quality control in point-of-care testing: where’s the evidence?”, Annals of Clinical Biochemistry, vol. 53, no. 2, pp. 233-239, 2016.
[5] “ISO 22870:2016 – Point-of-care testing (POCT) — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/71119.html. [Accessed: 25- Jul- 2018].
[6] J. Gill and M. Shephard, “The Conduct of Quality Control and Quality Assurance Testing for PoCT Outside the Laboratory”, Clin Biochem Rev., vol. 31, no. 3, pp. 85-88, 2010.
[7] A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.
[8] C. Price, I. Smith and A. Van den Bruel, “Improving the quality of point-of-care testing”, Family Practice, vol. 35, no. 4, pp. 358-364, 2017.
[9] “ISO 15189:2012 – Medical laboratories — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/56115.html. [Accessed: 31- Jul- 2018].
[10] J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.
[11] G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.
Importance of External Quality Assessment (EQA)
External Quality Assessment (EQA) / Proficiency Testing (PT) allows for a comparison of a laboratory’s testing procedures to other laboratories across the world. Comparisons can be made to a peer group of laboratories or to a reference laboratory.
EQA involves running blind patient-like samples, comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results.
Participating in an EQA scheme allows a laboratory to gather valuable data, this data can be used in a variety of ways [1]:
EQA provides assurance to both staff and customers that testing taking place at your laboratory provides accurate and reliable results. Problems can be identified early on and corrective action can be untaken. The reliability of methods, materials, and equipment can be evaluated and training can be developed and its impact monitored.
Large laboratory groups can compare their performance with sites across their group, ensuring accuracy and consistency no matter where testing takes place.
EQA participation is often a requirement for accreditation, gaining accreditation alone has a host of benefits, not least an increased confidence in results from customers, current and potential.
Read more about accreditation: ‘The Importance of Meeting ISO 15189 Requirements’.
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand for POCT has recently seen rapid growth, this comes from the advantages including the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.
EQA is strongly recommended for all point of care devices and is recommended by ISO 22870, which providesspecific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.
There are many External Quality Control schemes that come in different varieties. EQA schemes can be mandatory, required either by accreditation or law. Others are voluntary and carried out by laboratories who want to ensure that they are carrying out accurate testing and improve the quality of the lab’s performance [1].
A good EQA scheme should offer:
EQA is a great tool for comparing against a peer group and maintaining an effective QC strategy, however, it has its limitations.
EQA / PT alone cannot provide a complete evaluation alone; it is important to also run third party controls regularly. You can find out about the importance of third party controls here.
EQA results can also be affected by variables not relating to patient samples, including preparation, clerical functions, matrix effects, and selection of method. The errors can appear to be a downside to EQA but it can be used as a way to evaluate staff performance as well as assay performance.
If possible, every laboratory should participate in an EQA scheme that covers all testing procedures. Laboratories need to develop a management process with the objective to assure that EQA samples are treated appropriately and in the same manner. This includes, sample handling, sample analysis, record keeping, investigating deficiencies, taking corrective actions, and communicating results with laboratory staff and management.
Problems at any stage of sample analysis can cause errors, when an error does happen, all elements of the process need to be checked. Some examples of errors:
Pre Analysis
• Incorrect sample handling during preparation, shipping or storage
• Improper storage
• The material has expired
• An error in manufacturing
Analysis
• Instrument, calibration or reagent defects
• Staff competency
• Matrix effects
• Incorrect analysis method
Post Analysis
• Report misinterpretation
• Clerical or transcription errors
• Failure to take corrective action
• Where possible, all laboratories should participate in an EQA scheme for all tests that they perform.
• EQA samples should be treated in the same way as a patient sample, using the same procedures, instruments, methods, and staff who normally perform the testing.
• EQA provides valuable resources and data to effectively maintain accurate and reliable results and should be seen as educational.
Randox offers RIQAS, the largest EQA scheme in the world with over 45,000 participants across 133 countries, offering 33 consolidated programmes. Randox also offers a range of over 90 molecular programmes for infectious disease testing with Quality Control for Molecular Diseases (QCMD).
Features and Benefits
Fully accredited to ISO/IEC 17043:2010
Consolidated programmes
High frequency reporting
The highest quality material
User-friendly reports
To learn more about RIQAS, visit the RIQAS homepage.
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RIQAS Point of Care – FAQs
