Failure Modes and Effects Analysis (FMEA) - Complete Blood Count
Steps in the Failure Failure Failure Likelihood Likelihood Severity Risk Profile Actions to
Process Mode Causes Effects of of Detection (1-10) Number Reduce
Occurrence (1-10) (RPN) Occurrence
(1-10) Failure
Data Misinterpret Human Incorrect 3 6 10 180 Cross-check
Interpretatio ation of error during result critical
n and CBC data result report, values, use
Reporting interpretatio impacting automated
n clinical systems for
decisions preliminary
interpretatio
n.
Sample Mislabeling Lack of Mislabeling 3 6 10 180 Use quality
Collection the CBC proper can lead to control
sample given training or delayed or protocols that
human error wrong verify the
during diagnoses, correct
collection missed or labeling and
incorrect identification
treatments, of samples
blood before
transfusion processing.
errors, and
additional
laboratory
testing.
Reagent Incorrect Incorrect Inaccurate 5 4 8 160 Implement
Preparation reagent measuremen CBC results; barcode
preparation ts, expired potential for scanning and
for CBC reagents, misdiagnosis clear
Failure Modes and Effects Analysis (FMEA) - Complete Blood Count
improper labeling,
mixing perform
regular
calibration,
and establish
standard
mixing
procedures.
Sample Inadequate Insufficient This can lead 5 6 6 180
preparation mixing of the inversion of to clotting, Invert the
blood sample the tube: If especially in collection
the tube is the case of tube gently
not inverted underfilling, 8–10 times
enough times or the immediately
(typically anticoagulant after
8-10 gentle not being collection to
inversions), evenly mix the blood
the blood distributed and
may not be throughout anticoagulant
mixed the sample. . Avoid
properly with As a result, shaking the
the the test could tube, as it
anticoagulant yield could cause
. inaccurate hemolysis.
cell counts,
particularly
for platelets
and red
blood cells.