The Importance of Third Party Controls - LT324USA MAR 2014 | Page 6

Quality Control

Regulatory requirements reinforce the need to use
Third Party Quality 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.

“Controls independent of those
produced by the manufacturer of the
test or analyzer should be used.”

“…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.”

NATA

CLSI

The National Association of Testing Authorities, Australia (NATA)
recommends the use of independently produced controls over
pooled patient sera and manufacturer’s own controls as detailed in
Australian Standard 4633 (ISO 15189).
Supplemental Requirements for accreditation in the field of Medical testing.

The Clinical and Laboratory Standards Institute (CLSI) encourages
the use of third party controls in C24-A3, the Statistical Quality
Control for Quantitative Measurement Procedures.
Principles and Definitions; Approved Guideline – Third Edition, 6.2.1.