Importance of External Quality Assessment (EQA)

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Importance of External Quality Assessment (EQA)

The Importance of External Quality Control

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.

“EQA is defined as a system for objectively checking the laboratory’s performance using an external agency or facility.”
World Health Organisation (2009)
Benefits of EQA

Participating in an EQA scheme allows a laboratory to gather valuable data, this data can be used in a variety of ways [1]:


  • Enables a comparison of performance between laboratories.


  • Enables a comparison of performance between testing sites.
  • Provides an early warning for systematic errors.
  • Indicates areas for improvement.
  • Provides evidence of quality.
  • Identifies training areas.
  • Detects equipment faults, identify reagent problems and review staff training.
  • Compares performance to different analytical methods.

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.

“Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result” [2]
ISO 15189
Benefits of EQA in Point Of Care Testing (POCT)

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 shall be participation in external quality assessment schemes” [3]
ISO 22870

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:

  • Enables a comparison of performance between laboratories.
  • Frequent reporting and rapid report turnaround time to minimise the amount of time an error can go unnoticed.
  • High quality material in a format that works for you.
  • Well-designed reports that allow for quick and easy troubleshooting of erroneous results at a glance.
  • A sample matrix similar to a real patient sample.
  • Large participant numbers to provide a large peer group to compare results to.
  • A realistic range of analyte concentrations.


  • Your entire range of tests in consolidated programmes, saving you time and money.
“EQA should, as far as possible, cover the entire range of tests, and the entire examination process, from sample reception, preparation and analysis to interpretation and reporting.” [2]
ISO 15189

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


•  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

•  EQA is a system for objectively checking a laboratory’s performance using an external agency or facility [1].
•  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

Outlines the general requirements for proficiency testing and demonstrates our commitment to quality.



Consolidated programmes

Over 360 parameters in 33 comprehensive programmes, RIQAS streamlines EQA by reducing the number of programmes required.

High frequency reporting

More frequent reporting allows for early detection of errors and allows corrective action to be taken much sooner, reports are retuned within 24-72 hours of the submission deadline.



The highest quality material

All RIQAS programmes use the highest quality raw materials, this ensures that concentrations are clinically relevant and the sample performs like a real patient sample.

User-friendly reports

RIQAS reports are presented in a simple one page per parameter format, facilitating performance assessment at a glance.

To learn more about RIQAS, visit the RIQAS homepage.

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RIQAS Point of Care


[1] WHO, Overview of External Quality Assessment (EQA). World Health Organisation, 2009.

[2] ISO 15189:2012 Medical laboratories — Requirements for quality and competence, 3rd ed. ISO, 2014.

[3] ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence, 2nd ed. ISO, 2016.

RIQAS Point of Care – FAQs

RIQAS-POC-FAQ-Web-Banner Frequently Asked Questions

Why do I need to participate in an External Quality Assessment Scheme like RIQAS Point of Care?

Participation in an External Quality Assessment (EQA) scheme can help provide assurance and confidence that patient test results are accurate and reliable, therefore ensuring that the right clinical advice can be safely offered. Increasingly, commissioners of services like NHS Health Checks require assurance of satisfactory performance in an EQA scheme. In the UK, independent evidence of performance through participation in an EQA scheme is a requirement of the National Quality Assurance Advisory panel.

Read more about the importance and benefits of EQA

Is the RIQAS Point of Care scheme the right choice for us?

The RIQAS POC scheme is geared to assuring the quality of Point Of Care Testing in locations like pharmacies, General Practitioner surgeries, diagnostic/treatment and walk-in centres, sports clinics, and hospital out patients. Typically, the scheme is commissioned by a prime contractor (the client) on behalf of a chain of participants. The POC scheme complements the RIQAS scheme for laboratory-based analysers operated by specialist laboratory scientists.

Please contact us to determine which scheme is most suitable for your needs.

How many operators can be registered at each location?

As many as you wish. New operators can be added at any time, email addresses can be modified and the system is able to recognise operators who may be working at more than one location. In encouraging ownership responsibility for updates lies with the operators at each location.

What happens if we want to transfer an analyser to another location or replace an old analyser with a new one?

In order to participate in the next sample, distribution changes must be made before the 20th of each month. Participation contracts are renewable annually and new analysers can be added to the scheme at any time during the contract.


Samples are typically distributed on the first Monday of the month, results should be submitted online via the RIQAS Point of Care software before 5pm the following Monday.  Please see the Distribution Timetable for further information.


Samples should be kept refrigerated at between 2-8oC.  Do not freeze.

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RIQAS Point of Care


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ISO 22870- Are you meeting expectations?

Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.

There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.

POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;

  • Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
  • Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
  • Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
  • Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
  • Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
  • Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
  • Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel

In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.

Our Acusera liquid ready-to-use controls include:

  1. Blood Gas ControlA liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
  2. Liquid Cardiac ControlThis is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
  3. Liquid Urinalysis ControlLiquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
  4. Liquid HbA1c ControlThis is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.

Complementary EQA programmes are also available to meet the needs of ISO 22870.

ISO 22870:2006 in the Point-of-Care Testing (POCT) Market

Point-of-Care Testing (POCT)

The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;

“What are the challenges you face regarding POCT?”

“What do you see in the future for POCT?” (BIVDA, 2016)

Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.

ISO 22870:2006

The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).

With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.

For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;

“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”

How can Randox help?

Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.

We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.

Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel.  Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.

Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation.  With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!

By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.

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Acusera Quality Controls & RIQAS

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