The clinical laboratory is no longer its own limited
ecosystem, as it is increasingly integrated with patient
care, assisting diagnosis, monitoring therapies and
predicting clinical outcomes. Although efforts and
resources are continuously focused to achieve a satisfactory
degree of analytical quality, there is clear evidence
that the preanalytical phase is much more vulnerable
to uncertainties and accidents, which can
substantially influence patient care. Most errors within
the preanalytical phase result from system flaws
and insufficient audit of the operators involved in
specimen collection and handling responsibilities,
leading to an unacceptable number of unsuitable
specimens due to in vitro hemolysis, clotting, insufficient
volume, wrong container, contamination and
misidentification. A reliable approach to overcome
this problem entails prediction of accidental events
(exhaustive process analysis, reassessment and rearrangement
of quality requirements, dissemination of
operating guidelines and best-practice recommendations,
reduction of complexity and error-prone activities,
introduction of error-tracking systems and
continuous monitoring of performances), an increase
in and diversification of defenses (application of multiple
and heterogeneous systems to identify nonconformities),
and a decrease in vulnerability
(implementation of reliable and objective detection
systems and causal relation charts, education and
training). This policy, which requires integration
between requirements and design, full commitment
and interdepartmental cooperation, should make
laboratory activity more compliant to the inalienable
paradigm of total quality in the testing process.