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BioRad 3rd Party Controls
BioRad 3rd Party Controls
Third Party vs
Instrument
Controls Manufacturer Controls
The term “third party” is used to describe a Many instrument manufacturers provide both
quality control product that helps provide an calibrators and control materials for their own systems.
independent assessment of a diagnostic device These controls are designed for use only on their
or method, and is not optimized for any specific own test systems, but more importantly, they are
instrument or reagent system. Third party often manufactured from the same materials as the
controls are manufactured independently of calibrators. Consequently, the control may mimic the
the test system calibrators and reagents. Such calibrator, making it less sensitive to changes in device
controls generally begin with a human base performance. This can lead to acceptance of patient
matrix that helps provide a product more similar test results with analytical error that could be medically
to a patient sample. Third party controls with a important. Often times, a laboratory using a instrument
longer shelf life allow use of the same control lot manufacturer or in-kit control may receive a different
over multiple changes in reagents and calibrators, control lot with each new reagent lot. This does not
giving the laboratory the ability to detect shifts provide the laboratory with the benefits of long-term
that may occur with new reagents or calibrators. QC monitoring.
A control with a long shelf life allows for long-term QC monitoring across
different reagent lots and saves time and money due to fewer lot crossovers.
Year 1 Year 2 Year 3
1
Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes
Bio-Rad Laboratories QUALITY CONTROL
“. . . quality control materials should be different “Medical laboratories shall perform internal quality
from the calibrator materials to ensure that the QC control. Use of third party human matrix quality
procedure provides an independent assessment control is recommended for all analytes.”
of the measurement procedure’s performance in Essential Standards for Registration of Medical Testing
its entirety, including the procedure for calibration Laboratories in India, Quality Council of India
3.5.2 Quality Assurance
of the measurement.”
CLSI C24-A3, Statistical Quality Control for
Quantitative Measurement Procedures: Principles and “For each test system, the laboratory is responsible
Definitions; Approved Guideline—Third Edition, 6.2.1
for having control procedures that monitor the
Relation to Calibrators
accuracy and precision of the complete analytical
process.”
“Controls independent of those produced by the
42 CFR Part 493.1256 Medicare, Medicaid, and CLIA
manufacturer of the test or analyzer should Programs; Laboratory Requirements Relating to Quality
be used.” “The laboratory must have a system Systems and Certain Personnel Qualifications; Final Rule
1. T
he laboratory used in-kit controls provided by 3. Further
investigations revealed that the laboratory
the reagent manufacturer for their APTT testing. was unaware of a procedural change calling for
The values for these in-kit controls were found an adjustment in incubation time recommended
to be within the insert range provided by the by the manufacturer.
reagent manufacturer.
4. A
fter changing the procedure and correcting
2. B
io-Rad Lyphochek Coagulation Control was
®
the incubation time, the APTT values for the
also run, and the results were out of range (high). Bio-Rad Lyphochek® Coagulation Control were
then within the acceptable range.
Conclusion
he Bio-Rad Lyphochek® Coagulation Control detected a problem that led to the discovery of a procedural
T
error that potentially could have affected patient test results. The in-kit controls from the reagent manufacturer
did not detect this problem.
Read more stories, regulations and frequently asked questions online at thirdpartyQC.bio-rad.com
Detecting Shifts Following
Instrument Maintenance
A True Laboratory Situation
What Happened?
1. F
ollowing routine preventive maintenance on 3. A
fter additional troubleshooting, the technical
their instrument, results for the instrument specialist from the instrument manufacturer
manufacturer’s controls appeared to show no determined that the slide reading station needed
change, and were within the expected range. adjustment.
2. T
he laboratory manager noticed a shift in 4. F
ollowing adjustment of the slide reading station,
Triglyceride and Cholesterol values for the the Bio-Rad controls were within acceptable
Bio-Rad Lyphochek® Assayed Chemistry range again.
Control, causing them to be out of range on
the high side.
Conclusion
io-Rad Lyphochek® Assayed Chemistry Control detected a shift in the recoveries for Triglycerides and
B
Cholesterol that the instrument manufacturer’s control did not detect. This shift could have potentially affected
patient test results.
1. R
esults for the instrument manufacturer’s intact 3. R
ecalibrating and trying different reagent lots did
PTH control were within acceptable limits. not resolve the issue.
2. T
he results for intact PTH in Bio-Rad Liquichek™ 4. A
fter further investigations, the luminometer was
Specialty Immunoassay Control were higher replaced, and results for the Bio-Rad control
than expected. then agreed with the expected values.
Conclusion
The instrument manufacturer’s control did not identify any system problem. If a third party control (Bio-Rad
Liquichek™ Specialty Immunoassay Control) had not been tested, the problem with the luminometer could
have gone on undetected – potentially affecting patient test results.
Bio-Rad is Your Trusted
Partner For Third Party QC
Discover a comprehensive range of over
300 third party quality controls, including What Customers Say
controls for daily use and a wide selection About Bio-Rad QC
of External Quality Assurance Services
(EQAS) programs from the #1 choice in
independent, unbiased products. “I trust Bio-Rad controls
because they have not
been formulated for only
one specific test system.”
Lab Manager, France
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