CAP 15189SM

Program—
Measurement
Uncertainty Guideline
for Laboratories
Working Document
 Background – Why This Is Necessary
Starting in 2014, the CAP 15189 program will assess laboratories
according to the 2012 version of the ISO 15189 standard, rather
than the 2007 version.

The ISO 15189:2012 standard has revised text regarding measurement

uncertainty (MU). To clarify the laboratory’s responsibility and the
CAP’s assessment standards, we have developed this position
requirements statement.

Key Definitions
Measurement Uncertainty/MU — How certain you are of your results for
a particular measurement/testing process.

CLSI Definition: “Uncertainty (of measurement) — Nonnegative

parameter characterizing the dispersion of the quantity values being
attributed to a measurand, based on the information used.”1

Note: MU is a spot estimate of the error of a result based on known imprecision

within the range; the analytical measurement range (AMR) is the total range
of numbers from the quantitative measurement method that the laboratory
should have confidence in using.

Guideline
For each of its tests, a laboratory must have MU values that it can
provide if requested. For quantitative tests, this will represent the
expected variability in the result. For qualitative tests, this often
represents the sensitivity and/or specificity of the test.

Your laboratory does not have to report out the MU with every
result, but it must be able to supply it to any clinician who requests it.
The laboratory director must define and approve it. The laboratory
director must set performance requirements for MU, expressed as
a confidence level within a range.

© 2014 College of American Pathologists. All rights reserved. 2

 Further Practical Guidance
The practical estimation of MU for quantitative methods comes down
to calculating the standard deviation (SD) from statistical quality
control (SQC) data, then multiplying that SD by a coverage factor
to provide a confidence range for a test result. Typically done using
Gaussian statistics, a coverage factor of 1.95 or 2 is often used to give
expanded measurement uncertainty coverage of approximately 95%
(roughly assumes that 95% of the time the true value for the specimen
in question would be in this range). Bias is ignored in this approach, as
it assumes that the method calibration is traceable with minimal error
to a “true” reference value. If the error in the calibrator(s) is known,
include it in the MU calculation; however, when using commercial
calibrators, this often is not provided to the laboratory and, therefore,
cannot be determined or included in the MU calculation. Ideally,
the SD used to provide a measurement uncertainty value for a given
patient result should be determined at or close to the reported value;
when using quality control values to provide an SD, use the data from
the control with the closest mean value to the patient result to provide
the MU.

The following reference guide2 can be used to explain the CAP 15189
program position:

MU is dependent on intermediate actions, for example

• Calibration results
• Proficiency testing (PT) results
If your laboratory is not meeting these, your MU calculation is invalid.

If you detect an instrument out of calibration, this negates the MU

assessment.

If you fail PT, this also negates the MU assessment, because it shows
you don’t have a constant system.

© 2014 College of American Pathologists. All rights reserved. 3

 References
1. Joint Committee for Guides in Metrology. JCGM 200–International
vocabulary of metrology–Basic and general concepts and
associated terms (VIM). JCGM website.
http://www.iso.org/sites/JCGM/VIM-introduction.htm.
Updated December 9, 2009. Accessed June 26, 2014.

2. Westgard JO. Getting practical about measurement uncertainty.

WESTGARD QC website.
http://www.westgard.com/labs-must-mu-htm.
Updated June 18, 2014. Accessed June 18, 2014.

© 2014 College of American Pathologists. All rights reserved. 4

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