Third party quality controls are important to ensure accurate patient test results. They provide an independent assessment of analytical performance compared to controls from instrument or reagent manufacturers. The document describes several examples where Randox third party controls detected errors that dedicated manufacturer controls failed to identify, including instrument faults, procedural errors, and shifts in results between reagent batches. Regulatory bodies recommend using third party controls over manufacturer controls to independently monitor testing quality.

1. Importance of
Third Party Quality Controls
QUALITY CONTROL
Complete QC solutions for results you can trust

2. In the clinical laboratory Quality Control (QC) refers to the process of detecting analytical errors
to ensure both the reliability and accuracy of patient test results. Poor performance can result in
misdiagnosis, delayed/inappropriate treatment, increased costs and may even be potentially life
threatening for the patient.Without a good quality control system, how can you be confident the
results you release are accurate?
‘The purpose of quality control is to monitor the analytical
quality of a procedure, detect changes and eliminate
reporting results with medically important errors’ 1
1
Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes
Quality Control
There are three types of Quality Control
material:
1. Instrument, kit, or method manufacturer
supplied quality control
(Dedicated/Dependent Controls)
2. Independent manufacturers of
quality controls
(Third Party Controls)
3. Independently manufactured controls
intended for use with a specific instrument
(Semi-dependent Controls)
qual-ity con-trol
Noun
A system of maintaining standards in manufactured products by testing a sample of the output against the specification.
(Oxford Dictionary; Oxford Universities Press 2013)
1

3. VSMany instrument and reagent manufacturers provide dedicated
quality controls for use with their own reagents and analysers.
These controls are not as effective as third party controls and often
mask a multitude of weaknesses, ultimately leading to the release of
incorrect patient results.
• Often the same raw materials are used to manufacture the controls and calibrators
making the control less sensitive to performance changes.
• Laboratories using reagent dedicated controls will receive a new lot of QC with each
new batch of reagent, meaning they are frequently changing lot number and do not
benefit from long term QC monitoring.
•Value assignment is frequently based on a limited number of results generated exclusively
using the manufacturer’s own instrument, reagent and calibrator resulting in perceived
accuracy.
• In many cases, dedicated controls will not cover the patient reportable range,
preventing the assessment of performance at key decision levels.
Randox Third Party Controls
Instrument Dependent Controls
Third Party is the term used to describe a control that has not been
designed or optimised for use with a specific test or system. As
such, they mirror the performance of patient samples providing an
unbiased, independent assessment of analytical performance.
• Randox true third party controls are manufactured independently from our reagents and
calibrators, therefore they can even be used with Randox reagents on the RX series of analysers.
• Our unique value assignment process employs thousands of independent laboratories
ensuring statistically valid targets are available for multiple instruments and methods.
• With a shelf life of up to four years, laboratories can ensure continuity of lot supply whilst enabling
long term QC monitoring.
•The availability of multi-analyte, multi-instrument controls will reduce costs and preparation time,
consolidating multiple instrument specific controls into a single control product.
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4. Helping to Detect Errors within the Laboratory
The following real life case studies
highlight the importance of third
party controls and how they can
be used to help identify instrument,
reagent and procedural errors
which, if undetected, could lead to
the reporting of incorrect patient
results!
1) The laboratory used the reagent manufacturer’s QC for all
Bilirubin testing. The assay appeared to be performing well,
with QC results within range.
2) They also ran the Randox Acusera Assayed Chemistry
Premium Plus Control and the results reported were
approximately 25% lower than the target.
3) The laboratory contacted the RandoxTechnical Services
team, who provided them with some EQA samples.
4) As suspected, results for these samples were 25% lower than
expected.
5) Further investigations confirmed the low results were due to
an instrument fault.
Instrument Faults
SUMMARY
RandoxThird Party Controls identified an instrument fault that the
dedicated controls from the reagent manufacturer failed to detect.
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5. SUMMARY
The Randox Immunoassay Control detected a procedural error
that the reagent manufacturer’s control did not.
1) A laboratory using the Randox Acusera Immunoassay
Premium Plus Control reported their QC results for
Thyroglobulin were four times higher on their main analyser
compared to other systems.
2) They ran the instrument manufacturer’s control
alongside the Acusera control but it did not show the same
problem.
3) After reviewing EQA data, the RandoxTechnical Services
team confirmed there was a significant difference in results
compared to other instruments.
4) The customer contacted their instrument manufacturer, who
advised of a positive bias with several batches of reagent.
1) A laboratory using the Randox Immunoassay Premium Plus
Control reported their QC results for SHBG were much
higher than the target value provided.
2) They also ran the reagent manufacturer’s control and
confirmed that results were within the ranges supplied.
3) After reviewing the reagent kit insert, the Randox
Technical Services team noted that their instrument
automatically dilutes patient samples but not controls.
4) The customer was unaware of this and had not been diluting
the controls. Good laboratory practice is to run quality
control materials the same way as a patient sample.
Procedural Errors
Shifts After Changing Reagent Batch
SUMMARY
The Randox Immunoassay Control detected a shift in results that
the instrument dedicated control did not.
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6. “Controls independent of those produced by the
manufacturer of the test or analyser
should be used.”
Regulatory Requirements Reinforce the Need to use
Third Party Controls
Many regulatory bodies and standards from
around the world highly recommend the use
of true third party controls over those of the
instrument or reagent manufacturer.
NATA
AS 4633 (ISO 15189).
Supplemental Requirements for accreditation in the field of
Medical testing.
“…quality control materials should be different
from the calibrator materials to ensure that the QC
procedure provides an independent assessment of
the measurement procedure’s performance in its
entirety, including the procedure for calibration of
the measurement.”
CLSI
CLSI C24-A3 Statistical Quality Control for Quantitative
Measurement Procedures.
Principles and Definitions;Approved Guideline – Third Edition,
6.2.1.
“Medical laboratories shall perform internal quality
control. Use of third party human matrix quality
control is recommended for all analytes.”
QCI
Essential Standards for Registration of Medical Testing
Laboratories in India, 3.5.2 Quality Assurance.
“Use of third party human matrix controls
independent of those produced by the manufacturer of
the test or analyser should be used”
DAC Dubai
Accreditation Requirements for Medical Field ofTesting DAC-REQ-10
“Use of independent third party control materials
should be considered, either instead of, or in addition
to, any control materials supplied by the reagent or
instrument manufacturer”
ISO 15189 5.6.2.2
ISO 15189:2012 Medical Laboratories - Requirements
for quality and competence
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7. Highest Quality Material
Randox controls are the most commutable
available providing a matrix that reacts to the
examining system in the same manner as a
patient sample. Our lyophilised controls contain
no added preservatives or stabilisers which can
cause interference.
Acusera Third Party Controls
The Acusera range of true third party controls is extensive, covering over 390 routine and esoteric parameters.
All controls are designed to deliver unbiased performance assessment with any instrument or method.
Randox controls have the most accurately
assigned target values and ranges on the
market. This is made possible through access
to a unique database of over 31,000 laboratory
participants.
Accurate Target Values Consolidation
With Randox multi-analyte QC, you can
dramatically reduce the number of controls
used in your laboratory and save money by
replacing multiple instrument specific controls
with a single multi-analyser product.
Randox lyophilised controls have a shelf life
of up to four years enabling long term QC
monitoring. The extended working stability of
Acusera controls means they meet and often
exceed the stability claims quoted.
Unrivalled Stability
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8. Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com
Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151
6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA.
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