Importance of External Quality Assessment (EQA)

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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
WHAT MAKES A GOOD EQA SCHEME?

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
LIMITATIONS OF EQA

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.

PARTICIPATING IN EQA

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.

SOURCES OF ERROR

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
QUICK SUMMARY
•  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 INTERNATIONAL QUALITY ASSESSMENT SCHEME (RIQAS)

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.

Continue Reading

RIQAS

RIQAS Point of Care

References

[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.

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